Comparing three sedation methods for colonoscopy
Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
This study will test which sedation method—midazolam plus fentanyl, propofol alone, or fentanyl plus propofol—provides the best balance of comfort and safety for adults aged 18–60 having an elective colonoscopy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 157 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Qassim Health Cluster Academic / other |
| Locations | 1 site (Unaizah, Al-Qassim Region) |
| Trial ID | NCT06763705 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded, prospective Phase 4 trial will enroll 157 adults scheduled for elective colonoscopy at King Saud Hospital in Unaizah and randomly assign them to one of three sedation regimens. Group I will receive intravenous midazolam plus fentanyl, Group II propofol alone, and Group III fentanyl plus propofol, with doses titrated by trained staff under anesthesiologist supervision. Outcomes include sedation depth (OAA/S scale), time to sedation onset, patient and endoscopist satisfaction, procedure completion rate, adverse events, and recovery time, with continuous monitoring of vital signs. Data will be analyzed using ANOVA-based methods to compare safety and efficacy across groups.
Who should consider this trial
Good fit: Adults aged 18–60 with ASA physical status I or II who are scheduled for elective colonoscopy, can give informed consent, and have no contraindications to midazolam, propofol, or fentanyl are ideal candidates.
Not a fit: Patients older than 60, ASA III or higher, pregnant individuals, chronic benzodiazepine users, those with substance abuse, BMI >35 kg/m2, history of difficult airway, or allergies to the study drugs are excluded and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify a sedation approach that improves patient comfort, shortens recovery, and reduces sedation-related complications during colonoscopy.
How similar studies have performed: Previous randomized trials have generally shown propofol yields faster onset and recovery with safety comparable to benzodiazepine–opioid regimens, though results comparing combined regimens vary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adults aged 18-60 years * Both Genders * Indication of colonoscopy procedure without advanced intervention * American Society of Anesthesiologists (ASA) physical status I or II * Competent to give informed consent * Exclusion criteria: * Personal history of allergic reaction or other contra-indications to midazolam, propofol or fentanyl * Age below 18 or above 60 years * Chronic use of benzodiazepines * ASA physical status III or above * Pregnancy * History of smoking or alcohol abuse * Body mass index \> 35 kg/m2 * History of airway obstruction or difficult intubation
Where this trial is running
Unaizah, Al-Qassim Region
- King Saud Hospital — Unaizah, Al-Qassim Region, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Mohammed S Alsulaimi, consultant gastroenterologist
- Email: Dr.abosaud@windowslive.com
- Phone: +966 551132380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.