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

Comparison of Total Intravenous Anesthesia vs. Inhalational Anesthesia on Brain Relaxation, Subdural Pressure and Hemodynamics in Patients With Acute Subdural Hematoma Undergoing Emergency Craniotomy- A Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Subdural Hematoma
• Intervention / Treatment: Drug: Propofol; Drug: Isoflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Puducherry, India, 605006
    • Preethi.J

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• Extradural hematoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P; Maintenance of anesthesia with 100-150mcg/kg/min propofol, O2 and air and FiO2 of 40%	Drug: Propofol; Intraoperative anesthesia will be maintained using propofol 100-150 mcg/kg/min, oxygen and air and FiO2 of 40% in propofol group (GROUP P)
Active Comparator: Group I; Maintenance of anesthesia with 1 MAC of isoflurane,O2 and air and FiO2 of 40%	Drug: Isoflurane; in(GROUP I) maintenance will be done with 1 MAC of isoflurane, oxygen and air and FiO2 of 40%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brain relaxation score	At the time of dura opening

Secondary Outcome Measures

Outcome Measure	Time Frame
intracranial pressure	at the time of creating first burr hole
blood pressure	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
Mean arterial pressure	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
heart rate	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
Cardiac output	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
Stroke volume	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
Stroke volume variations	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
systemic vascular resistance	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
cardiac index	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
cerebral perfusion pressure	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

Collaborators and Investigators

• Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 11, 2018
• Study Completion (Actual): December 27, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Acute; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Isoflurane
• Other Study ID Numbers: PGRMC-27.10.2016/29

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No