| CTRI Number |
CTRI/2024/08/072931 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
study of comparison of quality of recovery in patients undergoing lumbar spine surgery under general anaesthesia versus spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of quality of recovery after lumbar spine surgery under general anaesthesia versus spinal anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tirumala Sai Ram Reddy P |
| Designation |
Post GraduateTrainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
9676117043 |
| Fax |
|
| Email |
P.tejareddy777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajmohan Rao T |
| Designation |
Professor |
| Affiliation |
kalinga Institute of medical sciences |
| Address |
Depatment of Anaesthesiology,Kalinga Institute of Medical Sciences,
KIIT deemed to be university,Bhubanesswar
Khordha
ORISSA
751024
India |
| Phone |
9701185818 |
| Fax |
|
| Email |
rajmohanrao@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajmohan Rao T |
| Designation |
Professor |
| Affiliation |
kalinga Institute of medical sciences |
| Address |
Depatment of Anaesthesiology,Kalinga Institute of Medical Sciences,
KIIT deemed to be university,Bhubanesswar
Khordha
ORISSA
751024
India |
| Phone |
9701185818 |
| Fax |
|
| Email |
rajmohanrao@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| kalinga Institute of medical sciences, bhubaneswar, odisha, 751024. |
|
|
Primary Sponsor
|
| Name |
Tirumala Sai Ram Reddy P |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences, KIIT deemed to be university,
Bhubaneswar,751024 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| P Tirumala Sai Ram Reddy |
Pradyuman Bal Memorial Hospital, Kalinga institute of medical sciences |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar,751024
Khordha
ORISSA |
9676117043
p.tejareddy777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUNAL ETHICS COMMITEE KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia |
Group 1 : patient will be induced with general anaesthesia post operative quality of recovery score QOR 15 will be assessed
after 24 hours |
| Intervention |
Spinal Anaesthesia |
Patient will be operated under spinal Anaesthesia post operative quality of recovery score QOR15 will be assessed after 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)American Society of Anesthesiologists (ASA) physical status I and II posted for single level lumbar spine fusion and decompression surgeries.
2)Age: 18 – 75 Years |
|
| ExclusionCriteria |
| Details |
1) History of allergy to the local Anesthetic drugs, which will be used in the study
2) Contraindication for spinal anesthesia
3) Increased intracranial pressure
4) Sepsis at site of injection
5) Coagulopathy
6) Morbid obesity (BMI MORE THAN 35) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary Outcome of the study will be to compare the Quality of Recovery (QoR-15) after lumbar spine surgery under Spinal Anaesthesia versus General Anaesthesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Hemodynamic changes.
2) Blood loss
3) Duration of surgery
4) Postoperative nausea and vomiting
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Recovery after surgery and Anaesthesia is a complex process dependent on patient condition, surgical procedure, duration of surgery and type of anaesthesia. Quality of recovery (QoR15) score after anaesthesia is an important measurement of early postoperative health status of patients. (2) The Aim of our study is to compare the Quality of Recovery (QoR15) after Lumbar spine surgery under spinal anaesthesia and general anaesthesia |