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

NCT07190612 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: FMASU MD228/2024
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Upper Gastrointestinal Endoscopy; Anesthesia

Keywords

sedation; ketamine; dexmetomidine; propofol; upper endoscopy; anesthesia; midazolam

Outcome Measures

Primary Outcomes (2)

• Recovery time

  The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.

  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.

  Preoperatively - before the surgery

Secondary Outcomes (8)

• 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

Study Arms (3)

Group 1

EXPERIMENTAL

Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule)

Drug: Dexmedetomidine and propofol

Group 2

EXPERIMENTAL

Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule)

Drug: ketamine and propofol

Group 3

EXPERIMENTAL

Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule)

Drug: Midazolam and propofol

Interventions

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.

Also known as: Precedex, Diprivan

Group 1

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.

Also known as: Dormicum, Diprivan

Group 3

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.

Also known as: Ketam

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Dexmedetomidine; Propofol; Midazolam; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Hazem Mohammad, Msc.

  AinShams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem M Hazem Mohamed Sabry, Specialist, MMsc.

CONTACT

00201006948041; hazem.mohamed@med.asu.edu.eg

Ahmad Mostafa, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three study groups: propofol in combination with either: midazolam, dexmetomidazine, or ketamine.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: September 24, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share