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

Ain Shams University

Status and phase: Not yet enrolling; Phase 4

Conditions: Upper Gastrointestinal Endoscopy; Anesthesia

Treatments: Drug: ketamine and propofol; Drug: Dexmedetomidine and propofol; Drug: Midazolam and propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07190612

FMASU MD228/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine and propofol

Group 2

Experimental group

Description:

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

Treatment:

Drug: ketamine and propofol

Group 3

Experimental group

Description:

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

Treatment:

Drug: Midazolam and propofol