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Completed

NCT Number: NCT07190612

Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures

The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.

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Key information

Conditions

Upper Gastrointestinal Endoscopy Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Precedex, Diprivan

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.

Other names: Dormicum, Diprivan

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.

Other names: Ketam

Primary outcomes

  1. 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.

  2. Induction time

    Time frame: Preoperatively - before the surgery

    The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.

Secondary outcomes

  1. Mean arterial pressure (MAP)(mmHg)

    Time frame: perioperatively

    systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure

  2. Ramsay Sedation Scale

    Time frame: 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).

  3. Endoscopist satisfaction

    Time frame: Perioperatively

    Endoscopist assessment of the sedation as excellent/good/not bad/bad

  4. Endoscopy procedure time

    Time frame: Peri- operatively

    The duration of time the endoscope was in the oral orifice.

  5. Rescue propofol total doses (mg)

    Time frame: 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

  6. Sedation-related adverse effects (SRAEs) and complications

    Time frame: 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.

  7. Heart rate

    Time frame: Perioperatively

    (beats/min)

  8. Peripheral oxygen saturation (SPO2)

    Time frame: Perioperatively

    oxygen %

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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