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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam + Fentanyl | Experimental | 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 |
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| Propofol | Experimental | 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 |
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| Propofol +Fentanyl | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | It will not be used alone but in combination with Fentanyl in the Midazolam + Fentanyl group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of sedation | The degree of sedation shows the depth of sedation. It will be measured by the Observer's assessment of alertness/sedation scale with a minimum and maximum value of 1 and 5 reflecting depth of sedation. Where score 1 means deeply sedated while score 5 means fully awake. Higher scores means not enough sedation. | every 3 minutes till the end of procedure |
| Onset of sedation | Onset of sedation means how rapidly patient is sedated after giving the sedative medication. if after 20 minutes, patient not sedated then it will be considered failed to sedate. | It will be measured every 1 minute till 20 minutes. |
| Adverse events and complication | Adverse events are any unintended or undesirable clinical occurrences that arise during or after a medical procedure, treatment, or intervention. These events may be related to the procedure itself, the medications administered. These may include hypotension, bradycardia, tachycardia, hypoxia, oversedation leading to respiratory suppression | Monitored continuously during procedure and post procedure for 2 hours and then up to 48 hours after discharge on telephone |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's satisfaction with the procedure | It reflects patient's overall satisfaction about the colonoscopy procedure under given sedation. It will be assessed on Likert scale with minimum and maximum values of 1 to 5. On the Linkert scale 5 is maximum satisfaction and 1 is the least. | 2 hours from the start of the procedure. |
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Inclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud Hospital | Unaizah | Al-Qassim Region | 56437 | Saudi Arabia |
IPD data will not be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2025 | Jan 6, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D015742 | Propofol |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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a randomized, double-blinded study 3 arms study
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| Propofol | Drug | It will used alone in Propofol group and in combination with Fentanyl in the Propofol + Fentanyl group. |
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| Fentanyl | Drug | 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. |
|
| procedure completion rate |
The colonoscopy procedure will be considered successful if the endoscopist examines the colon from the rectum to the cecum. it will be done at 1 hour.The procedure completion rate, representing the percentage of successful procedures, will be calculated six months after collecting all data from the study. |
| Decision for procedure completion successfully or not will be at 1 hour. Procedure completion rate at 6 months |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |