Acute Subdural Hematoma Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03284190 -
Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study
|
N/A | |
| Recruiting |
NCT06364059 -
A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
|