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Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

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ClinicalTrials.gov Identifier: NCT03806374
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE January 2, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Intubation with less hemodynamic changes [ Time Frame: 15 minutes after induction of anesthesia. ]
    changes in blood pressure with intubation
  • Smooth Maintenance of anesthesia [ Time Frame: anesthesia time ]
    changes in blood pressure during anesthesia
  • less postoperative pain killers [ Time Frame: 24 hours postoperative ]
    amount of pain killers used and timing
  • Intubation with less hemodynamic changes [ Time Frame: Anesthesia time ]
    changes in pulse rate during anesthesia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?
Official Title  ICMJE Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?
Brief Summary To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.
Detailed Description Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
    ketamine
  • Drug: Propofol
    propofol
  • Drug: Fentanyl
    fentanyl
  • Drug: Cisatracurium
    cisatracurium
  • Drug: Lidocaine
    lidocaine
Study Arms  ICMJE
  • Active Comparator: Fentanyl
    Administered propofol and fentanyl for induction.
    Interventions:
    • Drug: Propofol
    • Drug: Fentanyl
    • Drug: Cisatracurium
  • Active Comparator: Ketamine and lidocaine
    Administered propofol, ketamine and lidocaine for induction.
    Interventions:
    • Drug: Ketamine
    • Drug: Propofol
    • Drug: Cisatracurium
    • Drug: Lidocaine
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 10, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I and II between
  • Age between 18-55 years
  • Undergoing minor surgical procedure less than an hour.

Exclusion Criteria:

  • Patients with hypertension
  • Patients with Ischemic heart diseases
  • Patients with chronic renal or liver diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806374
Other Study ID Numbers  ICMJE ASUH9418
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Anis Metry, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date January 2019

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