Conscious Sedation for Outpatient Colonoscopy

Study Overview
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Brief Summary
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Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.

Detailed Description
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Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.

Official Title
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Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or II physical status 18-65 years Scheduled for elective colonoscopy Exclusion Criteria: History of allergy to any of the study drugs Alcohol or drug abuse. Second and third-degree heart block. Morbid obesity. Pregnant and lactating women. Psychiatric disorders. Severe cardiac, respiratory, renal, and liver diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (Dexmedetomidine)Dex group<br>The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure | Drug: Dexmedetomidine<br>* dexmedetomidine sedation<br>* Other names: dexmedetomidine infusion;|
| Active Comparator: Propofol-Remifentanil (P-R) group<br>Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. | Drug: Propofol<br>* propofol sedation<br>* Other names: propofol infusion;Drug: Remifentanil<br>* Remifentanil sedation<br>* Other names: Remifentanil infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation | Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation. | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure | Mean arterial blood pressure in mmHg | Perioperative | 
| Heart rate | Heart rate in beats/minutes | Perioperative | 
| Oxygen saturation | Arterial oxygen saturation as a percentage of the total haemoglobin. | Perioperative | 
| Hypotension | Number of patients with hypotension | Perioperative | 
| Bradycardia | Number of patients with bradycardia | Perioperative | 
| Analgesia | Measured by visual analogue scale [from 0 no pain to 10 worst imaginable pain] | Perioperative |