Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Not Applicable

Completed

• Conditions: Sedation and Analgesia
• Interventions: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT04597268
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic procedures.

Detailed Description

Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or IV ketamine or IV midazolam; to study the effect of their combination on level of sedation and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic procedures.

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patients scheduled for gastrointestinal endoscopic procedures
• ≥ Age 18 years
• ASA I-II

Exclusion Criteria

• Allergy to any of the used drugs
• impaired renal or liver functions
• hypertensive patients
• patients with cardiovascular
• cerebrovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam	IV midazolam
dexmedetomidine	Dexmedetomidine	IV dexmedetomidine
ketamine	Ketamine	IV ketamine

Primary Outcome Measures

Name	Time	Method
Ramsy sedation score (RSS)	3 to 6 months	time to achievement of Ramsy sedation score (RSS) 3-4, Ramsy sedation scale score from 1 to 6, 1 meaning anxious and 6 meaning no response to stimulus

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt