Upper Gastrointestinal Endoscopy, Anesthesia
Conditions
Keywords
sedation, ketamine, dexmetomidine, propofol, upper endoscopy, anesthesia, midazolam
Brief summary
The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.
Detailed description
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.
Interventions
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.
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Three study groups: propofol in combination with either: midazolam, dexmetomidazine, or ketamine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Both male and female patients aged between 18 and 65 years * Patients who are scheduled for elective upper gastrointestinal endoscopic procedures with sedation * Patients who are classified as ASA (American Society of Anesthesiologists) I and II
Exclusion criteria
* Patient's refusal to participate * Respiratory compromise as patients with respiratory failure or with active chest conditions, e.g., bronchial asthma or pneumonia * Cardiovascular compromise including heart failure and shocked patients * Severe uncontrolled hematemesis with shock or risk of aspiration. * Patients who are allergic or have any contraindications to any of the used drugs. * Patients who have a chronic neuropsychiatric disorder or are on a neuropsychiatric drug. * Patients on long-term sedative medication have a history of drug or alcohol abuse. * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively. | The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score. |
| Induction time | Preoperatively - before the surgery | The time to reach a sedation level of ≥ 4 on Ramsay's sedation score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ramsay Sedation Scale | Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours. | 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). |
| Endoscopist satisfaction | Perioperatively | Endoscopist assessment of the sedation as excellent/good/not bad/bad |
| Endoscopy procedure time | Peri- operatively | The duration of time the endoscope was in the oral orifice. |
| Rescue propofol total doses (mg) | Perioperatively | 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 |
| Mean arterial pressure (MAP)(mmHg) | perioperatively | systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure |
| Sedation-related adverse effects (SRAEs) and complications | Perioperatively | 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. |
| Heart rate | Perioperatively | (beats/min) |
| Peripheral oxygen saturation (SPO2) | Perioperatively | oxygen % |
Contacts
Primary ContactHazem M Hazem Mohamed Sabry, Specialist, MMsc.
Backup ContactAhmad Mostafa, PhD
Outcome results
None listed