NCT06763705

Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (estimated)
• Sponsor: Qassim Health Cluster · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blinded, prospective study which will be conducted at the Department of Gastroenterology, King Saud Hospital, Unaizah, Qassim, Saudi Arabia. This study aims to compare safety and efficacy of different types of sedation medications for elective colonoscopy. Colonoscopy is a procedure to examine and visualize the colon by a fiberoptic tube called colonoscope. Sedation helps one to relax to avoid feel any discomfort or pain during the procedure.

Detailed description

The study will involve 157 patients who meet the inclusion criteria and are scheduled for elective colonoscopy. Sample size is calculated by ANOVA F test. Participants will be randomly assigned into three groups using computer-based randomization. Group I will receive intravenous midazolam + fentanyl, Group II will receive propofol only, and Group III will receive fentanyl + propofol. Dosages will be titrated as needed during the procedure, with sedation administered by trained nurses/doctors under the supervision of an anesthesiologist to ensure patient safety. Experienced endoscopists will perform the procedures, and all participants will undergo a pre-procedure evaluation, including medical history, physical examination, and assessment of allergies, comorbidities, and ASA classification. Data on patient demographics, procedure details, and sedative dosages will be collected, alongside monitoring of vital signs, oxygen saturation, and blood pressure before, during, and after the procedure. The primary outcomes for the study include the degree of sedation, onset of sedation, patient satisfaction, and procedure completion rate. The degree of sedation will be assessed using the Observer's Assessment of Alertness/Sedation (OAA/S) scale, while the onset of sedation will be defined as the time it takes for the patient to show drowsiness and reduced responsiveness. Secondary outcomes include adverse events, recovery time, and endoscopist satisfaction. Adverse events, such as hypotension, tachycardia, bradycardia, and hypoxia, will be recorded using pre-defined criteria for each. Recovery will be assessed every 10 minutes post-procedure using the Aldrete score, with a score of 10 indicating full recovery, after which patients can be discharged. Both patient and endoscopist satisfaction will be measured on a scale of 0 to 5 using Likert scale. This comprehensive approach aims to determine the efficacy, safety, and patient/endoscopist experience associated with the three sedative regimens during colonoscopy

Conditions

• Deep Sedations
• Conscious Sedation
• Colonoscopy

Interventions

Type	Name	Description
DRUG	Midazolam	It will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group.
DRUG	Propofol	It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group.
DRUG	Fentanyl	Fentanyl will not be used in isolation but will be used in combination with either Midazolam or Propofol in Midazolam + Fentanyl group and Propofol + Fentanyl group, respectively.

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-12-15
• Completion: 2025-12-31
• First posted: 2025-01-08
• Last updated: 2025-07-25

Locations

1 site across 1 country: Saudi Arabia