Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I; Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane	Drug: dexmedetomidine 0.25 µg/kg IV
ACTIVE_COMPARATOR: Group II; Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane	Drug: dexmedetomidine 0.5 µg/kg IV
ACTIVE_COMPARATOR: Group III; Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane	Drug: dexmedetomidine 1 µg/kg IV
PLACEBO_COMPARATOR: Group IV; Patients in Group IV will receive same volume of normal saline at closure of sevoflurane	Drug: Placebo Comparator; Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (ESTIMATE): May 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: anesthesia; recovery; optimal dose of dexmedetomidine; prevent shivering; improve quality of emergence; without delay
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: ANES.MA.10