Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia Recovery Anesthesia Emergence Shivering Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane

Group Type ACTIVE_COMPARATOR

dexmedetomidine 0.25 µg/kg IV

Intervention Type DRUG

Group II

Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane

Group Type ACTIVE_COMPARATOR

dexmedetomidine 0.5 µg/kg IV

Intervention Type DRUG

Group III

Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane

Group Type ACTIVE_COMPARATOR

dexmedetomidine 1 µg/kg IV

Intervention Type DRUG

Group IV

Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Interventions

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dexmedetomidine 0.25 µg/kg IV

Intervention Type DRUG

dexmedetomidine 0.5 µg/kg IV

Intervention Type DRUG

dexmedetomidine 1 µg/kg IV

Intervention Type DRUG

Placebo Comparator

Patients in Group IV will receive same volume of normal saline at closure of sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No