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The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.
The investigators aim to compare the efficacy of ketamine-propofol, dexmedetomidine-propofol, and midazolam-propofol combinations as procedural sedative agents for adult patients undergoing elective upper gastrointestinal endoscopic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule) |
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| Group 2 | Experimental | Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule) |
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| Group 3 | Experimental | Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine and propofol | Drug | Dexmedetomidine infusion syringe (50mls): will be filled with 2mls of dexmedetomidine (200µg) diluted in 48 ml of 0.9% normal saline to make a final volume of 50mls and a final dexmedetomidine concentration of 4µg/ml. It will be infused as 1µg /kg/hr iv. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score. | From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively. |
| Induction time | The time to reach a sedation level of ≥ 4 on Ramsay's sedation score. | Preoperatively - before the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure (MAP)(mmHg) | systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure | perioperatively |
| Ramsay Sedation Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazem Mohammad, Msc. | AinShams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Cairo | Egypt |
Due to confidentiality
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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 | Jul 20, 2024 | Sep 14, 2025 |
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Three study groups: propofol in combination with either: midazolam, dexmetomidazine, or ketamine.
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| Midazolam and propofol | Drug | Midazolam infusion syringe (50mls): will be filled with 10mls of Midazolam (50mg) diluted in 40mls 0.9% normal saline to make a final volume of 50mls to reach a final midazolam concentration of 1mg/ml. It will be administered as a bolus dose of 0.05 mg/kg iv over 2 minutes then infused at a rate of 0.025mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. |
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| ketamine and propofol | Drug | Ketamine infusion syringe (50mls): will be filled with 2mls of ketamine (100mg) diluted in 48mls 0.9% normal saline to make a final volume of 50mls to reach a final ketamine concentration of 2mg/ml. It will be administered as a bolus dose of 0.25 mg/kg iv then infused at a rate of 0.25mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. |
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All patients will be targeted to reach deep sedation defined as a Ramsay Sedation Scale score of ≥4 (scale range: 1-6; 1 = anxious/awake, 6 = no response to stimuli).
| Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours. |
| Endoscopist satisfaction | Endoscopist assessment of the sedation as excellent/good/not bad/bad | Perioperatively |
| Endoscopy procedure time | The duration of time the endoscope was in the oral orifice. | Peri- operatively |
| Rescue propofol total doses (mg) | In the case of RSS<4 or if the patient shows limb movement at any time within the procedure, propofol 20 mg IV increments will be given, and total given doses in mg will be recorded | Perioperatively |
| Sedation-related adverse effects (SRAEs) and complications | Any incidence of respiratory (e.g. apnea, desaturation) or hemodynamic compromise (e.g hypotension, bradycardia, tachycardia, arrhythmia, cardiac arrest) or any other adverse effects (e.g. nausea, vomiting, allergy, seizure, recovery agitation, and delayed recovery) will be managed accordingly and documented. | Perioperatively |
| Heart rate | (beats/min) | Perioperatively |
| Peripheral oxygen saturation (SPO2) | oxygen % | Perioperatively |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2024 | Sep 14, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2024 | Sep 14, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| D008874 | Midazolam |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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