Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy

Qassim Health Cluster

Status and phase: Enrolling; Phase 4

Conditions: Deep Sedations; Conscious Sedation; Colonoscopy

Treatments: Drug: Midazolam; Drug: Fentanyl; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06763705

607/45/15284

Details and patient eligibility

About

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.

Full 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

Enrollment: 157 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 3 patient groups

Midazolam + Fentanyl

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Midazolam

Propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Propofol +Fentanyl

Experimental group

Description:

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

Treatment:

Drug: Propofol

Drug: Fentanyl