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

July 27, 2025 updated by: Eron Ashraf Faried, Minia University

Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Eron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Ketamine group recieve induction and maintenance doses of ketamine by target controlled infusion in addition of propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy
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 in addition of propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy
Drug: Ketamine
Total intravenous anesthesia in craniotomy
Other Names:
  • Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of brain relaxation score
Time Frame: Intraoperative
1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Collaborators

Minia University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 685-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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