| CTRI Number |
CTRI/2024/10/074675 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effect two type of anaesthesia on patients undergoing lumbar spine surgery |
|
Scientific Title of Study
|
Comparison of general anaesthesia versus spinal anaesthesia on perioperative
outcomes in lumbar spine surgery: A retrospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUBODH KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesiology,Pain medicine & Critical care
Room No.- 434, Surgical Block, AIIMS,New Delhi
South
DELHI
110029
India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBODH KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesiology, Pain medicine & Critical care
Room No.- 434, Surgical Block, AIIMS,New Delhi
DELHI
110029
India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUBODH KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Department of Anaesthesiology, Pain medicine & Critical care
Room No.- 434, Surgical Block, AIIMS,New Delhi
DELHI
110029
India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar
New Delhi -110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS
Ansari Nagar
Delhi - 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| SUBODH KUMAR |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Pain Medicine & Critical care
Room NO. -434,Surgical Block
AIIMS
Ansari Nagar, Delhi
110029
South
DELHI |
9793184350
SUBODH.08AIIMS@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTE ETHICS COMICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M510||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with myelopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a. Age ≥ 18 years. |
|
| ExclusionCriteria |
| Details |
a. Revision spine surgery
b. Spine surgery for fracture and neoplasm
c. Combined spinal epidural anaesthesia.
d. Incomplete and inadequate records
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of time to discharge after lumbar spine surgery between the two anaesthetic techniques. |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Comparison of post operative opioid consumption, postoperative nausea & vomiting (PONV), time to ambulation, blood loss, blood transfusion, surgeon satisfaction score & complications |
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Anaesthesia for lumbar spine surgery only general anaesthesia (GA) flashes in anaesthesiologists mind. However now this immutable fact has been challenged by recent literature which places spinal anaesthesia (SA) noninferior to GA for lumbar spine surgery. Predilection for GA in lumbar spine surgery thought to be not just anaesthesiologists and surgeons prejudice but also of patients which cannot be supported by evidences. Spine surgery has undergone a paradigm shift in recent times with the introduction of minimally invasive spine surgery which are of less duration and have better surgical outcome.Anaesthesia for these surgeries are also undergoing fundamental changes from GA to SA with the backing of recent evidence. It has been found that SA may be more advantageous in terms of perioperative hemodynamics, postoperative nausea vomiting (PONV), length of hospital stay and operation cost. However there appears to be conflicting evidence regarding superiority of SA over GA as few studies have found SA associated with more intraoperative hypotension ,cough , hiccup etc. The purpose of this retrospective study is to compare the perioperative and postoperative outcome between SA and GA among the patients who had undergone lumbar spine surgery. |