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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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