Conscious Sedation for Outpatient Colonoscopy

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925779
• Other study ID #: 2019/3/15/9
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2019
• Est. completion date: January 5, 2021

Study information

• Verified date: January 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 5, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine sedation
• Propofol
propofol sedation
• Remifentanil
Remifentanil sedation

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation	Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.	Perioperative
Secondary	Mean arterial blood pressure	Mean arterial blood pressure in mmHg	Perioperative
Secondary	Heart rate	Heart rate in beats/minutes	Perioperative
Secondary	Oxygen saturation	Arterial oxygen saturation as a percentage of the total haemoglobin.	Perioperative
Secondary	Hypotension	Number of patients with hypotension	Perioperative
Secondary	Bradycardia	Number of patients with bradycardia	Perioperative
Secondary	Analgesia	Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]	Perioperative