Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures
- Conditions
- Upper Gastrointestinal EndoscopyAnesthesia
- Interventions
- Registration Number
- NCT07190612
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Dexmedetomidine and propofol Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule) Group 2 ketamine and propofol Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule) Group 3 Midazolam and propofol Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mean arterial pressure (MAP)(mmHg) perioperatively systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure
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
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 %