Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

Sedation and Analgesia Clinical Trial

Official title:

Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597268
• Other study ID #: AP2007-50110
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 30, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation and Analgesia

Intervention

Drug:
• Dexmedetomidine
intravenous dexmedetomidine 1 mic/kg
• Ketamine
ketamine 1mg/kg
• Midazolam
midazolam 0.05 mg/kg

Locations

Country	Name	City	State
Egypt	Walaa Y Elsabeeny	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ramsy sedation score (RSS)	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	3 to 6 months