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Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures

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ClinicalTrials.gov Identifier: NCT04597268
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2020)		 Ramsy sedation score (RSS) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)		 Ramsy sedation score (RSS) [ Time Frame: 3 to 6 months ]
time to achievement of Ramsy sedation score (RSS) 3-4
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures
Official Title  ICMJE Safety and Efficacy of Dexmedetomidine vs Ketamine vs Midazolam Combined With Propofol in Gastrointestinal Procedures for Cancer Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation and Analgesia
Intervention  ICMJE
  • Drug: Dexmedetomidine
    intravenous dexmedetomidine 1 mic/kg
    Other Name: propofol- dexmedetomidine
  • Drug: Ketamine
    ketamine 1mg/kg
    Other Name: propofol- ketamine
  • Drug: Midazolam
    midazolam 0.05 mg/kg
    Other Name: propofol- midazolam
Study Arms  ICMJE
  • Experimental: dexmedetomidine
    IV dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Experimental: ketamine
    IV ketamine
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    IV midazolam
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)		 75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 25, 2021
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Walaa Y Elsabeeny, MD 01007798466 ext 002 walaa.elsabeeny@nci.cu.edu.eg
Contact: Nahla N Shehab, MD 01221682808 ext 002 nahla.shehab2@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04597268
Other Study ID Numbers  ICMJE AP2007-50110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data available upon reasonable request through contacting the corresponding author
Responsible Party Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
Study Sponsor  ICMJE National Cancer Institute, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walaa Y Elsabeeny, MD Lecturer
Study Director: Nahla Y Shehab, MD Lecturer
PRS Account National Cancer Institute, Egypt
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP