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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
75
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.
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.
Recovery time
The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.
Time frame: 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.
Time frame: Preoperatively - before the surgery
Mean arterial pressure (MAP)(mmHg)
systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure
Time frame: perioperatively
Ramsay Sedation Scale
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).
Time frame: 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
Time frame: Perioperatively
Endoscopy procedure time
The duration of time the endoscope was in the oral orifice.
Time frame: 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
Ahmad Mostafa, PhD
CONTACT
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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.
Time frame: 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.
Time frame: Perioperatively
Heart rate
(beats/min)
Time frame: Perioperatively
Peripheral oxygen saturation (SPO2)
oxygen %
Time frame: Perioperatively