| CTRI Number |
CTRI/2010/091/000616 [Registered on: 06/08/2010] |
| Last Modified On: |
31/03/2015 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of two anaesthetic drugs- desflurane and isoflurane in patients undergoing elective neurosurgery. |
|
Scientific Title of Study
|
A prospective, randomized, double-blinded study comparing the effects of Desflurane and Isoflurane on emergence from anaesthesia and recovery of post-operative motor deficits in patients undergoing elective neurosurgery for supratentorial mass lesions. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Aparanjit Paul |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesia
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282105 |
| Fax |
04162232035 |
| Email |
aparanjitpallapati@yahoo.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Grace Korula |
| Designation |
|
| Affiliation |
None |
| Address |
Department of Anaesthesia
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282105 |
| Fax |
04162232035 |
| Email |
grace.korula@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Aparanjit Paul |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anesthesiology
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
|
| Fax |
|
| Email |
aparanjitpaul@gmail.com |
|
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Source of Monetary or Material Support
|
| Fluid Research Grant from the Christian Medical College and Hospital, Vellore - 632004. |
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Primary Sponsor
Modification(s)
|
| Name |
Dr Aparanjit Paul |
| Address |
Department of Anesthesiology
CMCH, Vellore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology and Neurological Sciences |
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Grace Korula |
Christian Medical College and Hospital, Vellore |
Department of Anaesthesia,Christian Medical College and Hospital-632004
Vellore
TAMIL NADU |
04162282105
04162232035
grace.korula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College Vellore Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Emergence from anaesthesia and recovery of early post-operative neurological deficits, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane |
0.8 MAC |
| Comparator Agent |
Isoflurane |
0.8 MAC |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
a) Previous craniotomy
b) Hepatic or renal disease (elevated SGOT/SGPT/ALP/creatinine)
c) Alcohol or drug abuse
d) Hypothyroidism? any thyroid function test outside normal limits
e) BMI > 35
f) Midline shift > 5mm on CT/MRI
g) Female patients ? pregnant/breastfeeding
|
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| i. Time to obeying motor commands
ii. Time to extubation
iii. Time to eye opening
iv. Time to orientation
v. Time to recovery of motor deficits
|
i-iv. At end of surgery
v. withing 12 hours after surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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) |