AnesthesiaNCT07105618
Total Intravenous Anesthesia in Patients Undergoing Craniotomy
A study testing Dexmedetomidine, Fentanyl and Magnesium in people with Anesthesia, run by Zagazig University at 1 site in Egypt.
Trial summary
Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine, Fentanyl and Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- Physical status: American Society of Anesthesiologists Physical Status (ASA) 1\& II.
- Body mass index ≤ 30 kg/m2.
- Type of operation: elective craniotomy for brain tumor resection.
- Duration of surgery: within 4 hours.
Who cannot join
- Patient with hemodynamic instability or anticipated postoperative mechanical ventilation.
- Patients with a known history of allergy to the study drugs.
- Advanced hepatic, renal, cardiovascular, and neurologic diseases.
- Patients with chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy
Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications.
Read the detailed description
Total intravenous anesthesia, particularly with propofol-based regimens, has gained favor in neurosurgical procedures for its neuroprotective properties, and reduced intracranial pressure; however, the choice of adjunct agents in total intravenous anesthesia remains a subject of ongoing investigation, especially regarding their influence on hemodynamic stability, analgesia, brain relaxation, and postoperative outcomes.
Total intravenous anesthesia techniques for craniotomy allow rapid recovery and stable hemodynamic parameters, so they decrease the hospital stay. The current study will compare the efficacy and safety profiles of dexmedetomidine, fentanyl, and magnesium sulfate as adjuncts in total intravenous anesthesia for patients undergoing craniotomy.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine, Fentanyl, Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine as an adjunct to total intravenous anesthesia.
FentanylDrug
Fentanyl as an adjunct to total intravenous anesthesia.
MagnesiumDrug
Also called Magnesium sulphate
Magnesium sulphate as an adjunct to total intravenous anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Intravenous loading dose of dexmedetomidine 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour. Receives: Drug: Dexmedetomidine |
| Fentanyl group | Active comparator | Intravenous loading dose of fentanyl 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour. Receives: Drug: Fentanyl |
| Magnesium group | Active comparator | Magnesium sulphate 30-50 mg/kg intravenous over 15-30 minutes before propofol infusion, followed by intraoperative maintenance infusion of 10-20 mg/kg/hour. Receives: Drug: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total intraoperative propofol consumption
The total intraoperative propofol consumption (in milligrams).
Measured: 4 hours
Secondary outcomes (6)
Intraoperative heart rate
Monitoring the changes in heart rate intraoperative.
Measured: 4 hours
Intraoperative mean arterial pressure
Monitoring the changes in mean arterial pressure intraoperative.
Measured: 4 hours
Brain relaxation score
Evaluating the brain relaxation right after the dura is opened using a scale from 1 to 4 (1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain).
Measured: 4 hours
Additional doses of intraoperative fentanyl.
The total number of patients requiring additional dose of intraoperative fentanyl.
Measured: 4 hours
The time to first request for rescue analgesia
The time to first request for rescue analgesia in first 24 hour.
Measured: The first 24 hours postoperative.
Postoperative pain assessment
Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery.
Measured: The first 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fatma Mahmoud Ahmed, MD, Principal investigator, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105618
- Sponsor's protocol ID
- Craniotomy anesthesia
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali AR, El Ghoneimy MN. Dexmedetomidine versus fentanyl as adjuvant to propofol: comparative study in children undergoing extracorporeal shock wave lithotripsy. Eur J Anaesthesiol. 2010 Dec;27(12):1058-64. doi: 10.1097/EJA.0b013e32833e6e2d.
PubMed 20805754Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.
PubMed 12393361Chandar Chinnarasan V, Bidkar PU, Swaminathan S, Mani M, Vairappan B, Chatterjee P, Joy JJ, Dey A, Ramadurai R, Gunasekaran A. Comparison of dexmedetomidine versus fentanyl-based total intravenous anesthesia technique on the requirement of propofol, brain relaxation, intracranial pressure, neuronal injury, and hemodynamic parameters in patients with acute traumatic subdural hematoma undergoing emergency craniotomy: A randomized controlled trial. Surg Neurol Int. 2024 Dec 13;15:462. doi: 10.25259/SNI_892_2024. eCollection 2024.
PubMed 39777171Preethi J, Bidkar PU, Cherian A, Dey A, Srinivasan S, Adinarayanan S, Ramesh AS. Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial. Eur J Trauma Emerg Surg. 2021 Jun;47(3):831-837. doi: 10.1007/s00068-019-01249-4. Epub 2019 Oct 29.
PubMed 31664468
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy
- ClinicalTrials.gov ID
- NCT07105618
- Acronym / sponsor ID
- Craniotomy anesthesia
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications.
Detailed description
Total intravenous anesthesia, particularly with propofol-based regimens, has gained favor in neurosurgical procedures for its neuroprotective properties, and reduced intracranial pressure; however, the choice of adjunct agents in total intravenous anesthesia remains a subject of ongoing investigation, especially regarding their influence on hemodynamic stability, analgesia, brain relaxation, and postoperative outcomes.
Total intravenous anesthesia techniques for craniotomy allow rapid recovery and stable hemodynamic parameters, so they decrease the hospital stay. The current study will compare the efficacy and safety profiles of dexmedetomidine, fentanyl, and magnesium sulfate as adjuncts in total intravenous anesthesia for patients undergoing craniotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidineIntravenous loading dose of dexmedetomidine 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour. |
| Fentanyl group | Active comparator | Drug: FentanylIntravenous loading dose of fentanyl 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour. |
| Magnesium group | Active comparator | Drug: MagnesiumMagnesium sulphate 30-50 mg/kg intravenous over 15-30 minutes before propofol infusion, followed by intraoperative maintenance infusion of 10-20 mg/kg/hour. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- Physical status: American Society of Anesthesiologists Physical Status (ASA) 1\& II.
- Body mass index ≤ 30 kg/m2.
- Type of operation: elective craniotomy for brain tumor resection.
- Duration of surgery: within 4 hours.
Key exclusion criteria (4 listed)
- Patient with hemodynamic instability or anticipated postoperative mechanical ventilation.
- Patients with a known history of allergy to the study drugs.
- Advanced hepatic, renal, cardiovascular, and neurologic diseases.
- Patients with chronic opioid use.
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine as an adjunct to total intravenous anesthesia. | Drug | Dexmedetomidine group |
| FentanylFentanyl as an adjunct to total intravenous anesthesia. | Drug | Fentanyl group |
| MagnesiumAlso: Magnesium sulphateMagnesium sulphate as an adjunct to total intravenous anesthesia. | Drug | Magnesium group |
Primary outcome
The total intraoperative propofol consumption
Time frame: 4 hours
The total intraoperative propofol consumption (in milligrams).
6 secondary outcomes
Intraoperative heart rate
Time frame: 4 hours
Intraoperative mean arterial pressure
Time frame: 4 hours
Brain relaxation score
Time frame: 4 hours
Additional doses of intraoperative fentanyl.
Time frame: 4 hours
The time to first request for rescue analgesia
Time frame: The first 24 hours postoperative.
Postoperative pain assessment
Time frame: The first 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 20805754Ali AR, El Ghoneimy MN. Dexmedetomidine versus fentanyl as adjuvant to propofol: comparative study in children undergoing extracorporeal shock wave lithotripsy. Eur J Anaesthesiol. 2010 Dec;27(12):1058-64. doi: 10.1097/EJA.0b013e32833e6e2d.
- Background: PubMed 12393361Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.
- Background: PubMed 39777171Chandar Chinnarasan V, Bidkar PU, Swaminathan S, Mani M, Vairappan B, Chatterjee P, Joy JJ, Dey A, Ramadurai R, Gunasekaran A. Comparison of dexmedetomidine versus fentanyl-based total intravenous anesthesia technique on the requirement of propofol, brain relaxation, intracranial pressure, neuronal injury, and hemodynamic parameters in patients with acute traumatic subdural hematoma undergoing emergency craniotomy: A randomized controlled trial. Surg Neurol Int. 2024 Dec 13;15:462. doi: 10.25259/SNI_892_2024. eCollection 2024.
- Background: PubMed 31664468Preethi J, Bidkar PU, Cherian A, Dey A, Srinivasan S, Adinarayanan S, Ramesh AS. Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial. Eur J Trauma Emerg Surg. 2021 Jun;47(3):831-837. doi: 10.1007/s00068-019-01249-4. Epub 2019 Oct 29.
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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.
Fatma Mahmoud Ahmed, MD principal investigator
Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Fentanyl and Magnesium in people with Anesthesia, run by Zagazig 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The total intraoperative propofol consumption (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07105618, which also lists 4 linked publications.
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 24 Aug 2026.