Conscious Sedation for Outpatient Colonoscopy

NCT03925779 | Completed Phase 2

• 1 other identifier: 2019/3/15/9
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation

  Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.

  Perioperative

Secondary Outcomes (6)

• Mean arterial blood pressure

  Perioperative

• Heart rate

  Perioperative

• Oxygen saturation

  Perioperative

• Hypotension

  Perioperative

• Bradycardia

  Perioperative

Study Arms (2)

(Dexmedetomidine)Dex group

ACTIVE COMPARATOR

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

Propofol-Remifentanil (P-R) group

ACTIVE COMPARATOR

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; Drug: Remifentanil

Interventions

Dexmedetomidine DRUG

dexmedetomidine sedation

Also known as: dexmedetomidine infusion

(Dexmedetomidine)Dex group

Propofol DRUG

propofol sedation

Also known as: propofol infusion

Propofol-Remifentanil (P-R) group

Remifentanil DRUG

Remifentanil sedation

Also known as: Remifentanil infusion

Propofol-Remifentanil (P-R) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II physical status
• years
• Scheduled for elective colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Officials

• Abd-Elazeem A Elbakry, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anaesthesia

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 24, 2019
• Study Start: June 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 5, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

EG (1)