| CTRI Number |
CTRI/2019/04/018478 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the anaesthesia recovery quality using three different agents in patients undergoing lumbar laminectomy |
|
Scientific Title of Study
|
Comparison of recovery profiles of patients undergoing lumbar laminectomy under propofol, sevoflurane or desflurane anesthesia. A randomized, prospective, clinical, comparative study |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Srivastava |
| Designation |
Professor |
| Affiliation |
SGPGI, Lucknow |
| Address |
Department of Anaesthesiology,
First Floor, A Block, SGPGI,Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904594 |
| Fax |
|
| Email |
shashian2002@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Srivastava |
| Designation |
Professor |
| Affiliation |
SGPGI, Lucknow |
| Address |
Department of Anaesthesiology,
First Floor, A Block, SGPGI,Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904594 |
| Fax |
|
| Email |
shashian2002@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar Verma |
| Designation |
Junior Residet |
| Affiliation |
SGPGI, Lucknow |
| Address |
Department of Anaesthesiology,
First Floor, A Block, SGPGI,Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904594 |
| Fax |
|
| Email |
drakverma80@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGPGI |
| Address |
Rae Bareilly Road , Lucknow,226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashi Srivastava |
SGPGI, Lucknow |
Dept.of Anaesthesiology, First Floor,A Block,SGPGI,Rae Bareilly Road Lucknow
Lucknow
UTTAR PRADESH |
8004904594
shashian2002@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee SGPGIMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol, Sevoflurane and Desflurane |
Comparing recovery profiles of patients undergoing surgery under propofol, sevoflurane or desflurane anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and II
2. Age between 18 to 65 year
3. Patients of either gender
4. Education level minimum up to 8th standard
5. Single or two level disease necessitating decompression/discectomy without instrumentation
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Inability to read or speak or communicate
3. Patients with psychiatric disorders/behavioral impairment or on antipsychotic drugs
4. Patients with significant hepatic, cardiovascular,pulmonary or renal disorders
5. Morbid obesity
6. Patients with allergy to study drugs or history of malignant hyperthermia
7. Chronic drug/alcohol abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To compare the preoperative versus postoperative cognitive and psychomotor recovery profiles of patients undergoing lumbar laminectomy and discectomy under general anaesthesia maintained with propofol, sevoflurane or desflurane. |
Thrice preoperatively. Post extubation at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours and at 4 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the incidences of postoperative complications like headache, giddiness, nausea, vomiting or pain at injection sites.
2) To compare the time taken by subjects administered these three anaesthetic regimens to achieve a modified Aldrete’s Score of 9.
3) To compare the satisfaction of the patients regarding the quality of anaesthesia
|
After 4 hours post intubation |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="79" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2019 |
| Date of Study Completion (India) |
31/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized clinical observational study aims to compare the postoperative cognitive and psychomotor recovery profiles of patient undergoing lumbar laminectomies under propofol, sevoflurane and desflurane anaesthesia. It utilises the Mini Mental status examination, Treiger Dot test and Digit Substitution test which are administered to the patients preoperatively and then in the post operative period ( at given time intervals) and their scoring which are reflective of their recovery characteristics are then recorded and analyzed later. As a secondary measure, the time taken to achieve discharge like recovery (Modified Aldrete score 9) and the incidences of side effects and the satisfaction levels of patients are also recorded. |