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TIVA: Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06031883
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total requirement of intra operative propofol and post operative analgesia

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Ketamine group recieve induction and maintenance doses of ketamine by target controlled infusion

Drug: Ketamine
Total intravenous anesthesia in craniotomy
Other Names:
  • Fentanyl

    		•
    Experimental: 2

    Fentanyl group recieve induction and maintenance doses of fentanyl by target controlled infusion

    Drug: Ketamine
    Total intravenous anesthesia in craniotomy
    Other Names:
  • Fentanyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of brain relaxation score [2 hours]

      1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients aged 18-70 years old ASA I - III with GCS 14-15 and BMI<35 scheduled for elective craniotomy for resection of supratentorial masses
    Exclusion Criteria:
    • Patients will be excluded if they will refuse to give a written consent. Also patients with GCS < 14 or having endocrine or blood diseases or sever cardiac disease or sever liver disease or renal failure and patients with uncontrolled hypertension or uncontrolled diabetes mellitus and patients have allergy to any of the study drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eron Minya Egypt

    Sponsors and Collaborators

    • Minia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eron Ashraf Faried, Eron Ashraf Faried, Minia University
    ClinicalTrials.gov Identifier:
    NCT06031883
    Other Study ID Numbers:
    • 685-2023
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Fentanyl
    Ketamine

    Study Results

    No Results Posted as of Sep 11, 2023