| CTRI Number |
CTRI/2015/01/005425 [Registered on: 19/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Effect of two different anaesthetic drugs (propofol versus desflurane) on higher mental functions undergoing neurosurgery for brsin haemorrhage |
|
Scientific Title of Study
|
Comparision of effect of desflurane and propofol on postoperative cognitive dysfunction in patients undergoing aneurysm neck clipping after sub arachnoid haemorrhage |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nanish SHARMA |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NANISH SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE ,PGIMER , CHANDIGARH
DEPARTMENT OF ANAETHESIA AND INTENSIVE CARE
Chandigarh
CHANDIGARH
160036
India |
| Phone |
8727049007 |
| Fax |
|
| Email |
nanish.sharma26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemant Bhagat |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE ,PGIMER , CHANDIGARH
DEPARTMENT OF ANAETHESIA AND INTENSIVE CARE
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NANISH SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE ,PGIMER , CHANDIGARH
DEPARTMENT OF ANAETHESIA AND INTENSIVE CARE
Chandigarh
CHANDIGARH
160036
India |
| Phone |
8727049007 |
| Fax |
|
| Email |
nanish.sharma26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE,PGIMER, CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NANISH SHARMA |
JUNIOR RESIDENT, DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE ,CHANDIGARH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NANISH SHARMA |
PGIMER , CHANDIGARH |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE ,CHANDIGARH
Chandigarh
CHANDIGARH |
8727049007
nanish.sharma26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (INTRAMURAL ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
aSAH Patients with ASA 1,2or3 with Hunt & Hess grade 1,2 or 3 with WFNS grade 1,2 or3, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DESFLURANE AS MAINTAINENCE AGENT |
DESFLURANE as INHALATIONAL ANAESTHETIC AGENT given targeted to depth of anaesthesia measured to BIS VALUE OF 40-60. |
| Intervention |
PROPOFOL AS MAINTENANCE AGENT |
PROPOFOL AS INTRAVENOUS ANAESTHETIC AGENT given as continous infusion with targeted depth of anaesthesia measured by BIS index (value 40-60) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
(1) Patients scheduled for aSAH surgery with clinical and radiological evidence of cerebral aneurysm.
(2) Age between 18 to 65 yrs.
(3) H and H grade 1 ,2 & 3 and WFNS grade 1, 2 & 3.
(4) ASA 1, ASA 2 and ASA 3 will be included
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
(1) Patients with systemic disease other than hypertension and diabetes mellitus.
(2) Patients with infectious diseases and respiratory complications.
(3) Duration of anesthesia more than six hours.
(4) Second operation.
(5) Low level of education.
(6) Patients with known psychiatric disease.
(7) Cardiovascular disease and respiratory impairment.
(8) History of drug abuse.
(9) Known allergy to any of the anesthetic agent to be used in study.
(10) Patients who are unconscious, intubated or tracheostomised even after two weeks following exposure to anesthesia will also be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparision of POCD between study group desflurane and propofol postoperatively |
MOCA score 0 to 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparision of haemodynamics and brain bulge between study groups desflurane and propofol intraoperatively |
brain bulge score 0 to4 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/07/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anaesthesiologist commonly use TIVA or inhalational agent in aneurysmal surgery. There is no randanmised trial comparing their effects in SAH patients undergoing craniotomy and clipping surgery.Both propofol and desflurane have the advantage of fast awakening and are popularin neurosurgical practice. Hence, this study is designed to prospectively evaluate the effects of propofol and desflurane on POCD in patients of aSAH undergoing craniotomy and clipping of aneurysmal neck. |