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CompletedNCT03146104Updated Feb 26, 2019

Comparison of Total Intravenous Anesthesia vs. Inhalational Anesthesia in Acute Subdural Hematoma Patients

A Phase 4 interventional study of Propofol and Isoflurane in Acute Subdural Hematoma, sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

Consent will be taken from the relatives and the patient will be taken to the operating room. Inside the operation theatre patient will be shifted to operating table and standard monitors will be attached. The patient will then be given induction agent to make him/her unconscious and unaware of the surrounding and muscle relaxant to prevent movement will be administered. He/she will be intubated with appropriate size tube to maintain airway. In order to maintain anesthesia he/ she will be given either of inhalational or intravenous anesthetic throughout the surgery. Intracranial pressure will be measured using venflon needle as soon as burr hole is created in the skull. Throughout the surgery patients vital parameters will be monitored and appropriate treatment will be given in case if the vitals are not stable.

Read the detailed description

Patients meeting inclusion criteria will be enrolled in the study and randomized into one of the two group's propofol - P and isoflurane - I. Preoperative Glasgow coma scale (GCS) and computer tomography (CT) findings will be recorded. Intraoperatively peripheral intravenous line will be secured, standard monitors including non invasive blood pressure (NIBP), electrocardiogram (ECG), heart rate (HR), pulse oximetry, SPO2 probe will be connected. Pre-oxygenation will be done with 100% O2 for 3 minutes. In both the groups induction will be done using 3 mcg/kg fentanyl, 2 mg/kg propofol and muscle relaxation will be achieved with 0.1mg/kg vecuronium. Post induction patients will be intubated with appropriate size endotracheal tube (male with 8.0 and female with 7.0) and radial artery will be cannulated with zero pressure adjustment at mid axillary line for continuous blood pressure monitoring and blood sampling. Central line will be secured using 7 French triple lumen central venous catheter in the subclavian vein or internal jugular vein. Cardiac output monitor (EV1000) will be connected to arterial and central line and values of stroke volume (SV), systemic vascular resistance (SVR), cardiac output (CO) and cardiac index (CI) will be obtained. Intraoperative anesthesia will be maintained using propofol 100-150 mcg/kg/min, oxygen and air and FiO2 of 40% in propofol group (GROUP P) whereas in isoflurane group (GROUP I) maintenance will be done with 1 MAC of isoflurane, oxygen and air and FiO2 of 40%. In both the groups Etco2 will be maintained at 32-33 mmHg. HR and IBP will be kept within +/- 20% of the baseline values. If the systolic blood pressure decreases more 20% of base line, crystalloids will be given as initial management and failing to improve blood pressure, vasopressors namely phenylephrine or dopamine will be given intravenously. At the time of scalp incision mannitol 1 gm/kg will be given over 20min. On creating first burr hole a 22G/0.8mm venflon cannula will be placed under dura and connected to a pressure transducer system via a polyethylene catheter. Zero level of ICP will be adjusted with the transducer kept at the level of mastoid process(6). The pressure measured will be the estimate for intracranial pressure. Cerebral perfusion pressure (CPP) will be calculated as the difference between mean arterial pressure MAP and ICP. If the intracranial pressure is more than 25 mmHg then moderate hyperventilation will be given with Etco2 of 25-28 mmHg. Once the dura is opened brain relaxation score will be assessed on four point scale, using tactile evaluation by neurosurgeon who will be blinded to anaesthetic technique. The tension will be categorized as follows:

  1. Perfectly relaxed
  2. Satisfactorily relaxed
  3. Firm brain
  4. Bulging brain Meanwhile hemodynamic stability in terms of heart rate, blood pressure, MAP, cardiac output, stroke volume , stroke volume variation, systemic vascular resistance, cardiac index, and cerebral perfusion pressure will be measured before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes until surgery is completed.
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Conditions studied

  • Acute Subdural Hematoma
03

In context

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients posted for emergency craniotomy with TBI having

    • Subdural hematoma
    • GCS \< 8
    • Age 18 to 60 years.
    • Both males and females

Exclusion criteria

Exclusion Criteria:

  • Extradural hematoma
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Group P

    Maintenance of anesthesia with 100-150mcg/kg/min propofol, O2 and air and FiO2 of 40%

    Drug: Propofol

  • Active comparator
    Group I

    Maintenance of anesthesia with 1 MAC of isoflurane,O2 and air and FiO2 of 40%

    Drug: Isoflurane

Interventions

  • Intraoperative anesthesia will be maintained using propofol 100-150 mcg/kg/min, oxygen and air and FiO2 of 40% in propofol group (GROUP P)

  • in(GROUP I) maintenance will be done with 1 MAC of isoflurane, oxygen and air and FiO2 of 40%.

06

What researchers measure

Primary outcomes

  1. Brain relaxation score

    Time frame: At the time of dura opening

Secondary outcomes

  1. intracranial pressure

    Time frame: at the time of creating first burr hole

  2. blood pressure

    Time frame: Before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  3. Mean arterial pressure

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  4. heart rate

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  5. Cardiac output

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  6. Stroke volume

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  7. Stroke volume variations

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  8. systemic vascular resistance

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  9. cardiac index

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

  10. cerebral perfusion pressure

    Time frame: before induction, at the time of induction and at 1 , 2, 3, 4, 5th minute after induction and thereafter every 15 minutes for a maximum of 5 hours

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Study locations

1 site
  • Preethi.J
    Puducherry, 605006, India
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References and documents

Publications

  • Preethi 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03146104
Lead sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Responsible party
Dr.Preethi.J (Principal investigator, Jawaharlal Institute of Postgraduate Medical Education & Research) — Principal investigator
First posted
May 9, 2017
Start date
Aug 1, 2017
Primary completion
Nov 11, 2018
Completion
Dec 27, 2018
Last update
Feb 26, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Propofol · Isoflurane

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