Patients Undergoing Elective CraniotomyPhase 1/2TIVANCT06031883
Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia
A Phase 1/2 study testing Ketamine in people with Patients Undergoing Elective Craniotomy, run by Minia University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients Undergoing Elective Craniotomy
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 5 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Patients Undergoing Elective Craniotomy
- Being tested
- Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Fentanyl
Total intravenous anesthesia in craniotomy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of brain relaxation score
1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Feb 2023
- Primary completion1 Dec 2024
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Elective CraniotomyStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University Hospital
- Responsible party
- Principal investigator, Eron Ashraf Faried, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031883
- Sponsor's protocol ID
- 685-2023
- Acronym
- TIVA
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia for Patients Undergoing Craniotomy
- ClinicalTrials.gov ID
- NCT06031883
- Acronym / sponsor ID
- TIVA / 685-2023
- Conditions
- Patients Undergoing Elective Craniotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Minia University Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: KetamineKetamine 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 |
| 2 | Experimental | Drug: KetamineFentanyl 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: FentanylTotal intravenous anesthesia in craniotomy | Drug | 1, 2 |
Primary outcome
Evaluation of brain relaxation score
Time frame: Intraoperative
1:perfectly relaxed , 2:satisfactory relaxed , 3:firm brain and 4:bulging brain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Patients Undergoing Elective Craniotomy
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RecruitingPhase 4
Effect of Volatile- Based Versus Total Intravenous Anesthesia on Brain Homeostasis and Neurocognitive Outcome
Brain Edema Caused by Drugs, Cerebral Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine in people with Patients Undergoing Elective Craniotomy, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of brain relaxation score (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.