Clinical trial NCT06763705: Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy
Official title: Evaluation of Safety and Efficacy of Non-anesthesia Provider-administered Different Anesthetic Regimens During Colonoscopy. Asingle Center, Prospective Double Blind, Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Deep Sedations
Conscious Sedation
Colonoscopy
Keywords: colonoscopy
Lead sponsor: Qassim Health Cluster
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, double-blinded study 3 arms study
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility 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

Primary outcomes:
measure: Degree of sedation
timeFrame: every 3 minutes till the end of procedure
measure: Onset of sedation
timeFrame: It will be measured every 1 minute till 20 minutes.
measure: Adverse events and complication
timeFrame: Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone
Secondary outcomes:
measure: Patient's satisfaction with the procedure
timeFrame: 2 hours from the start of the procedure.
measure: procedure completion rate
timeFrame: Decision for procedure completion successfully or not will be at 1 hour. Procedure completion rate at 6 months
Other outcomes:
Locations:
city: Unaizah
country: Saudi Arabia
facility: King Saud Hospital
state: Qassim
Study officials:
References: