| CTRI Number |
CTRI/2024/04/066479 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Desflurane ( a inhalational anesthetic agent) and Propofol ( a intravenous anaesthetic agent) in adult patients undergoing lumbar spine surgeries under general anesthesia. The emergence and recovery characteristics are compared among patients. |
|
Scientific Title of Study
|
Comparision of Desflurane and Propofol for emergence and recovery characteristics in adult patients undergoing lumbar spine surgeries under general 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 |
Kranthi Kumar Nannapaneni |
| Designation |
Junior Resident |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
2nd Floor, Department Of Anaesthesiology, Command Hospital Air Force, Cambridge Layout, HAL Road, Bangalore, Karnataka.
Bangalore KARNATAKA 560007 India |
| Phone |
9490575052 |
| Fax |
|
| Email |
drkranthibsf@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Avanish Bhardwaj |
| Designation |
Professor |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
2nd floor, Department Of Anaesthesiology, Command Hospital Air Force, Cambridge Layout, HAL Road, Bangalore, Karnataka.
Bangalore KARNATAKA 560007 India |
| Phone |
9914734466 |
| Fax |
|
| Email |
avanishbhardwaj78@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Avanish Bhardwaj |
| Designation |
Professor |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
2nd floor, Department Of Anaesthesiology, Command Hospital Air Force, Cambridge Layout, HAL Road, Bangalore, Karnataka.
Bangalore KARNATAKA 560007 India |
| Phone |
9914734466 |
| Fax |
|
| Email |
avanishbhardwaj78@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd Floor, Department Of Anaesthesiology, Command Hospital Air Force, Cambridge Layout, HAL Road, Bangalore, Karnataka, India 560007 |
|
|
Primary Sponsor
|
| Name |
Kranthi Kumar Nannapaneni |
| Address |
Department of Anaesthesiology, Command Hospital Air Force, Cambridge Layout, Bangalore, Karnataka, 560007 |
| Type of Sponsor |
Other [Command Hospital Air Force] |
|
|
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 Kranthi Kumar Nannapaneni |
Command Hospital Airforce (Bangalore) |
2nd Floor, Department of Anaesthesia, Command Hospital Air Force, Cambridge Layout, Bangalore, Karnataka, 560007. Bangalore KARNATAKA |
9490575052
drkranthibsf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Air Force |
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 |
| Intervention |
Desflurane , Propofol |
As general anaesthetic agents in adult patients undergoing lumbar spine surgeries. |
| Comparator Agent |
DESFLURANE , PROPOFOL |
Desflurane a inhalational anaesthetic agent and Propofol a intravenous anaesthetic agent are used for maintaining general anesthesia. They are given through out the time of surgery. Dose of these agents is adjusted as the desired effect to achieve anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lumbar spine surgeries under General Anaesthesia.
ASA physical status I and II |
|
| ExclusionCriteria |
| Details |
Significant cardiovascular , respiratory, hepatic, renal, neurological, psychiatric or metabolic.
Documented allergic reaction to the anaesthetic agent being used. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing “Modified Aldrete Score†between both the groups after extubation. |
AT 10Min, 20Min and 30Min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare time to extubation, spontaneous eye opening & response to verbal commands after switching off the anaesthetic agent.
Compare intraoperative hemodynamic stability by monitoring SBP, DBP, MAP, HR.
Compare requirement of blood products, total requirement of intravenous fluids, need for vasopressor & inotropes intra operatively
Visual Analogue Scale (VAS) scores at the time of discharge from post anaesthetic care unit (PACU) & Incidence of post operative nausea vomiting (PONV)
|
From the time of switching off the anesthetic agent the time taken will be recorded for extubation, eye opening & response to verbal command. |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
The proposed randomized controlled study will be conducted in the Department of Anaesthesia at Command Hospital (Air Force) Bengaluru. This study will be conducted on the patients undergoing lumbar surgeries under General Anaesthesia over a period of 18 months after approval from the Institutional ethical committee. Patients will be explained in detail regarding the study in their vernacular language and written informed consent will be obtained from them. All the 90 patients will be randomized using a computer-generated algorithm and concealment done using opaque sealed envelope into two groups with 45 patients in each group [n=45]. Group D patients will be receive Desflurane as the anaesthetic agent for maintenance of anaesthesia and Group P patients will receive Propofol as the anaesthetic agent for maintenance of anaesthesia. Demographic and clinical data including age, sex, height, weight, etc. will be recorded for all the patients. American Society of Anesthesiology (ASA) physical status, comorbidities and medications, if any will be noted. Recovery in the postoperative period will be compared in both the groups using "Modified Aldrete Score" which will be recorded at 10, 20 and 30 minutes after extubation in the post anaesthesia care unit. Comparing desflurane and propofol as an anaesthetic agent in spine surgeries can provide valuable insights into optimizing anesthetic plans, tailoring them to the specific demands of extended surgical procedures and ultimately contributing to enhanced patient care. |