Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Phase 4

• Conditions: Anesthesia Complication
• Interventions: Drug: Dexmedetomidine Hydrochloride; Drug: Normal Saline

• Registration Number: NCT03312413
• Lead Sponsor: Min Su

Brief Summary

Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.

American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-10
• Study First Submitted: 2017-09-04
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-12
• Last Update Submitted: 2017-10-12
• Study First Posted: 2017-10-17
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-08-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 30Kg/m2 ≥ BMI > 18Kg/m2;
2. undergoing general anesthesia;
3. ASA physical status I and II
4. undergoing elective thyroid surgery.

Exclusion Criteria

1. hyperthyroidism;
2. preoperative bradycardia;
3. liver function impairment;
4. renal function impairment;
5. heart function failure;
6. history of asthma or COPD;
7. history of diabetes;
8. cognition function impairment;
9. pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine high dose group	Dexmedetomidine Hydrochloride	Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Dexmedetomidine low dose group	Dexmedetomidine Hydrochloride	Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Dexmedetomidine median dose group	Dexmedetomidine Hydrochloride	Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery
Control group (normal saline group)	Normal Saline	Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery

Primary Outcome Measures

Name	Time	Method
Incidence of coughing during anesthetic emergence	within 10 minutes after endotracheal extubation	incidence of coughing within 10 minutes after extubation

Secondary Outcome Measures

Name	Time	Method
Ccoughing on a four-point scale during anesthetic emergence	within 10 minutes after endotracheal extubation	Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale
Ramsay score during anesthetic emergence	within 30 minutes after endotracheal extubation	Ramsay score 1min, 5min, 10min, and 30min after extubation
VAS pain score	within 48 hrs after endotracheal extubation	VAS pain score 30min, 24 hrs and 48 hrs after extubation
Respiratory rate (RR)	within 30min after endotracheal extubation	Respiratory rate 1min, 5min, 10min, and 30min after extubation
Heart rate	within 30 minutes after endotracheal extubation	Heart rate 1min, 5min, 10min, and 30min after extubation
mean arterial pressure	within 30 minutes after endotracheal extubation	Mean arterial pressure 1min, 5min, 10min, and 30min after extubation
Bruggrmann comfort scale score	within 24 hrs after endotracheal extubation	Bruggrmann comfort scale score 30min and 24 hrs after extubation

Trial Locations

Locations (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China