A clinical trial to compare the effects of two anaesthetic drugs- desflurane and isoflurane in patients undergoing elective neurosurgery.

Completed

• Conditions: Emergence from anaesthesia and recovery of early post-operative neurological deficits

• Registration Number: CTRI/2010/091/000616
• Lead Sponsor: Dr Aparanjit Paul

Brief Summary

This study is a prospective, double-blinded randomized controlled trial comparing the effects of 2 inhalational anaesthetic agents - desflurane and isoflurane with regard to emergence and recovery of early neurological deficits in patients undergoing supratentorial craniotomy. Our hypothesis is that desflurane causes quicker emergence from anaesthesia and faster recovery from an early post-operative neurological deficit compared to isoflurane. The study will be conducted on 60 adult (18 ? 70 years, ASA I-III) patients (30 patients in each arm) undergoing elective neurosurgery for supratentorial mass lesions. Primary outcome measures include time to extubation, eye opening, obeying motor commands, orientation and recovery of post-operative motor deficits. Secondary outcome measures include brain relaxation score and number of episodes of hypotension(MAP < 20% baseline), hypertension(MAP>20% baseline) and bradycardia (heart rate <45bpm)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-07
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• a)Elective neurosurgical patients with supratentorial intra-axial mass lesions b)Age 18 -75 years c)ASA grade I.
• III d)Pre-operative GCS ? 15/15.

Exclusion Criteria

• a)Previous craniotomyb)Hepatic or renal disease (elevated SGOT/SGPT/ALP/creatinine)c)Alcohol or drug abused)Hypothyroidism?
• any thyroid function test outside normal limitse)BMI > 35f)Midline shift > 5mm on CT/MRIg)Female patients ?
• pregnant/breastfeeding.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i.Time to obeying motor commandsii.Time to extubationiii.Time to eye openingiv.Time to orientationv.Time to recovery of motor deficits	i-iv. At end of surgery v. withing 12 hours after surgery

Secondary Outcome Measures

Name	Time	Method
I. Brain Relaxation Score II. Number Of Episodes Of : Hypotension(MAP < 20% Baseline), Hypertension(MAP>20% Baseline) And Bradycardia (Heart Rate <45bpm)	During the surgery

Trial Locations

Locations (1)

Christian Medical College and Hospital, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College and Hospital, Vellore

🇮🇳Vellore, TAMIL NADU, India

Dr. Grace Korula

Principal investigator

04162282105

grace.korula@gmail.com