NCT06031883

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

July 30, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

September 4, 2023

Last Update Submit

July 27, 2025

Conditions

Patients Undergoing Elective Craniotomy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of brain relaxation score

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

    Intraoperative

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

KetamineDRUG

Total intravenous anesthesia in craniotomy

Also known as: Fentanyl
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eron

Minya, Egypt

Location

MeSH Terms

Interventions

KetamineFentanyl

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eron Ashraf Faried

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 11, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

March 5, 2025

Last Updated

July 30, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)