Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Saudi Arabia
King Saud Hospital
RECRUITING
Unaizah
Contact Information
Primary
Mohammed S Alsulaimi, consultant gastroenterologist
Dr.abosaud@windowslive.com
+966 551132380
Backup
Muhammad Y Memon, FCPS,MRCP
memon.dryousuf@gmail.com
966 570357122
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 157
Treatments
Experimental: Midazolam + Fentanyl
Midazolam AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Midazolam: Initial dose 0.5-1 mg. Additional doses: 1 mg every 2-3 min depending sedation level, maximum dose: 6 mg. till completion of the colonoscopy procedure Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug
Experimental: Propofol
Propofol Before start of colonoscopy procedure patient will be sedated with propofol in this group. Dose:induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. Maximum total dose of 200 mg. Till completion of the colonoscopy
Experimental: Propofol +Fentanyl
Propofol AND Fentanyl Before start of colonoscopy procedure patient will be sedated with these drugs in this group. Doses: Propofol: Induction dose of 20-50 mg followed by intermittent boluses of 10-20 mg according to the patient response. maximum total dose of 200 mg. Till completion of the colonoscopy procedure.~Fentanyl Initial dose: 12.5-75 μg Additional doses: 12.5-50 μg every 2-3 minutes. Maximum dose: 100 ug. Till completion of the colonoscopy procedure
Related Therapeutic Areas
Sponsors
Leads: Qassim Health Cluster