Conscious Sedation for Outpatient Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Propofol; Drug: Remifentanil

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Shebin El-kom
    • Cairo, Shebin El-kom, Egypt, 32511
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (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	Drug: Dexmedetomidine; dexmedetomidine sedation; Other Names: dexmedetomidine infusion
Active Comparator: Propofol-Remifentanil (P-R) 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.	Drug: Propofol; propofol sedation; Other Names: propofol infusion; Drug: Remifentanil; Remifentanil sedation; Other Names: Remifentanil infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Abd-Elazeem A Elbakry, MD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: April 21, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• 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; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol; Dexmedetomidine
• Other Study ID Numbers: 2019/3/15/9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No