Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Induction time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group 1
Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule)
Intervention: Dexmedetomidine and propofol (Drug)
Group 2
Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule)
Intervention: ketamine and propofol (Drug)
Group 3
Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule)
Intervention: Midazolam and propofol (Drug)
Outcomes
Primary Outcomes
Induction time
Time Frame: Preoperatively - before the surgery
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
Recovery time
Time Frame: 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.
Recovery time
Time Frame: 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
Time Frame: Preoperatively - before the surgery
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
Secondary Outcomes
- Mean arterial pressure (MAP)(mmHg)(perioperatively)
- Ramsay Sedation Scale(Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.)
- Endoscopist satisfaction(Perioperatively)
- Endoscopy procedure time(Peri- operatively)
- Rescue propofol total doses (mg)(Perioperatively)
- Sedation-related adverse effects (SRAEs) and complications(Perioperatively)
- Heart rate(Perioperatively)
- Peripheral oxygen saturation (SPO2)(Perioperatively)
- Mean arterial pressure (MAP)(mmHg)(perioperatively)
- Ramsay Sedation Scale(Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.)
- Endoscopist satisfaction(Perioperatively)
- Endoscopy procedure time(Peri- operatively)
- Rescue propofol total doses (mg)(Perioperatively)
- Sedation-related adverse effects (SRAEs) and complications(Perioperatively)
- Heart rate(Perioperatively)
- Peripheral oxygen saturation (SPO2)(Perioperatively)