Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

Study Overview
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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.

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.

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

Conditions
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Anesthesia Recovery, Anesthesia Emergence, Shivering, Postoperative Recovery

Intervention / Treatment
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* Drug: dexmedetomidine 0.25 µg/kg IV
* Drug: dexmedetomidine 0.5 µg/kg IV
* Drug: dexmedetomidine 1 µg/kg IV
* Drug: Placebo Comparator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>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<br> <br> |
| Active Comparator: Group II<br>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<br> <br> |
| Active Comparator: Group III<br>Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane | Drug: dexmedetomidine 1 µg/kg IV<br> <br> |
| Placebo Comparator: Group IV<br>Patients in Group IV will receive same volume of normal saline at closure of sevoflurane | Drug: Placebo Comparator<br>* Patients in Group IV will receive same volume of normal saline at closure of sevoflurane<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optimal dose of dexmedetomidine, prevent shivering, improve quality of emergence, anesthesia, without delay, recovery