Effect of Dexmedetomidine After Thyroidectomy

Not Applicable

Completed

• Conditions: Thyroid Tumor
• Interventions: Drug: Desflurane; Drug: Remifentanil; Procedure: Thyroidectomy; Other: Vital signs; Behavioral: Cough reflex; Behavioral: Ramsay Sedation Scale; Other: Extubation time and Recovery time; Behavioral: Visual analogue scale; Other: Postoperative bleeding; Other: Postoperative complications; Other: Time to remove drainage and duration of hospital staying; Drug: Normal saline; Drug: Dexmedetomidine

• Registration Number: NCT02412150
• Lead Sponsor: Chosun University Hospital

Brief Summary

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).

Detailed Description

Smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. After thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation.

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-09
• Status Verified: 2020-11
• Primary Completion: 2020-11-21
• Study Completion: 2020-11-25
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

Inclusion Criteria

• Female patient,
• Aged 20-60 yr,
• ASA physical status 1-2,
• Patients undergoing elective thyroidectomy under general anesthesia

Exclusion Criteria

• Sighs of difficult airway,
• History of respiratory disease or chronic cough,
• Cardiovascular disease,
• Pregnant or breast-feeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine (Group D)	Thyroidectomy	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Vital signs	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Cough reflex	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Ramsay Sedation Scale	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Extubation time and Recovery time	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Postoperative bleeding	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Postoperative complications	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Time to remove drainage and duration of hospital staying	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Visual analogue scale	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Thyroidectomy	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Vital signs	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Cough reflex	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Ramsay Sedation Scale	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Extubation time and Recovery time	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Visual analogue scale	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Postoperative bleeding	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Postoperative complications	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Time to remove drainage and duration of hospital staying	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Normal saline	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Desflurane	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Remifentanil	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Dexmedetomidine (Group D)	Dexmedetomidine	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage and duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Desflurane	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.
Normal Saline (Group N)	Remifentanil	After induction of anesthesia, anesthesia is maintained with desflurane and remifentanil during thyroidectomy. Fifteen minutes before the end of surgery, infusion of remifentanil for surgery is discontinued. Then, normal saline has started infusion for 15 min (same rate as Group D). Vital signs and complications of testing drugs are measured before and after infusion of testing drugs. Five minutes before the end of surgery, anesthetic gas (desflurane) is discontinued. After patient has awake, extubation has done. Extubation time and Recovery time,Cough reflex,Ramsay Sedation Scale, Visual analogue scale, and surgical outcomes such as postoperative bleeding, time to remove drainage duration of hospital staying, postoperative complications are measured until POD#3.

Primary Outcome Measures

Name	Time	Method
Postoperative bleeding	From the end of surgery to the 3rd postoperative day (an expected average of 3 days)	Postoperative bleeding: Sum of bleeding via barovac

Secondary Outcome Measures

Name	Time	Method
Extubation time	During the recovery time of anesthesia, an expected average of 20 min	time to extubation from the end of surgery
Recovery time of anesthesia	During the recovery time of anesthesia, an expected average of 20 min	time to transfer to recovery room from the end of surgery
Duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Duration of hospital stay
Ramsay Sedation scale	During the recovery time of anesthesia, an expected average of 20 min	Ramsay Sedation scale at recovery room
Pain score	From the end of surgery to the 3rd postoperative day (an expected average of 3 days)	Pain score: NRS
Incidence of postoperative complications	Participants will be followed for the duration of hospital stay, an expected average of 1 week	Hoarseness, hematoma, and reoperation
Coughing Response	During the recovery time of anesthesia, an expected average of 20 min	Coughing Response during recovery from anesthesia

Trial Locations

Locations (1)

Chosun University Hospital; 🇰🇷 Gwangju, Donggu, Korea, Republic of