Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Phase 4

Completed

• Conditions: Anesthesia Recovery; Anesthesia Emergence; Shivering; Postoperative Recovery
• Interventions: Drug: dexmedetomidine 1 µg/kg IV; Drug: dexmedetomidine 0.25 µg/kg IV; Drug: dexmedetomidine 0.5 µg/kg IV; Drug: Placebo Comparator

• Registration Number: NCT02141412
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.

Detailed Description

Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-19
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• 18-80 year-old
• ASA class I, II, and III
• patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h

Exclusion Criteria

• duration of surgery less than 1h or more than 3 h
• allergy to dexmedetomidine
• vasoactive antidepressant or analgesics
• obesity (BMI>30)
• fever
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	dexmedetomidine 1 µg/kg IV	Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane
Group I	dexmedetomidine 0.25 µg/kg IV	Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane
Group II	dexmedetomidine 0.5 µg/kg IV	Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane
Group IV	Placebo Comparator	Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Primary Outcome Measures

Name	Time	Method
Postanaesthetic shivering incidence and score	change from baseline every 10 minutes up to 1 hour post-operatively
Quality of emergence from anesthesia	Change from baseline every 5 minutes till extubation	The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	every 10 minutes up to 1 hour post-operatively
Time to extubation, awakening and orientation	1 hour post-operatively
Pain scores	every 10 minutes up to 1 hour post-operatively
Patient's Temperature	every 10 minutes up to 1 hour post-operatively
Sedation scores	every 10 minutes up to 1 hour post-operatively

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon