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

NCT ID: NCT06031883

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-03-05

Brief Summary

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

Detailed Description

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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

Conditions

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Patients Undergoing Elective Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Total intravenous anesthesia in craniotomy

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Total intravenous anesthesia in craniotomy

Interventions

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Ketamine

Total intravenous anesthesia in craniotomy

Intervention Type DRUG

Other Intervention Names

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Fentanyl

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University Hospital

OTHER

Sponsor Role collaborator

Minia University

OTHER

Sponsor Role lead

Responsible Party

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Eron Ashraf Faried

Eron Ashraf Faried

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eron

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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685-2023

Identifier Type: -

Identifier Source: org_study_id

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