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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Total Intravenous Anesthesia vs. Inhalational Anesthesia on Brain Relaxation, Subdural Pressure and Hemodynamics in Patients With Acute Subdural Hematoma Und

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.

Detailed Summary:

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 creati
Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

Current Primary Outcome: Brain relaxation score [ Time Frame: At the time of dura opening ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • intracranial pressure [ Time Frame: at the time of creating first burr hole ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Jawaharlal Institute of Postgraduate Medical Education & Research

Dates:
Date Received: May 4, 2017
Date Started: July 2017
Date Completion: December 2018
Last Updated: May 5, 2017
Last Verified: May 2017