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

NCT03146104 | Completed Phase 4

• 1 other identifier: PGRMC-27.10.2016/29
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Brain relaxation score

  At the time of dura opening

Secondary Outcomes (10)

• 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

Study Arms (2)

Group P

ACTIVE COMPARATOR

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

Drug: Propofol

Group I

ACTIVE COMPARATOR

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

Drug: Isoflurane

Interventions

Propofol DRUG

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

Group P

Isoflurane DRUG

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

Group I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients posted for emergency craniotomy with TBI having
• Subdural hematoma
• GCS \< 8
• Age 18 to 60 years.
• Both males and females

You may not qualify if:

• Extradural hematoma

Sponsors & Collaborators

• Jawaharlal Institute of Postgraduate Medical Education & Research: lead

Study Sites (1)

Preethi.J

Puducherry, 605006, India

Location

Related Publications (1)

• 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.

  PMID: 31664468 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Acute

Interventions

Propofol; Isoflurane

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 9, 2017
• Study Start: August 1, 2017
• Primary Completion: November 11, 2018
• Study Completion: December 27, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

IN (1)