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CTRI Number  CTRI/2021/08/035860 [Registered on: 23/08/2021] Trial Registered Prospectively
Last Modified On: 20/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of gradual return of consciousness and recovey features of sevoflurane and desflurane inhaled anaesthesia drugs in patients after long duration surgeries under general anaesthesia 
Scientific Title of Study   “COMPARISON OF DESFLURANE AND SEVOFLURANE FOR EMERGENCE AND RECOVERY CHARACTERISTICS IN ADULT PATIENTS UNDERGOING PROLONGED SURGERIES(more than 4 hrs) UNDER GENERAL ANAESTHESIA”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramakrishna 
Designation  Junior Resident 
Affiliation  Command Hoapital Air Force 
Address  Department of Anaesthesiology command hospital Air Force

Bangalore
KARNATAKA
560007
India 
Phone  7013548299  
Fax    
Email  ramakrishnarendla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avanish Bhardwaj 
Designation  Associate Professor 
Affiliation  Command Hospital, Air Force 
Address  Dept of Anaesthesiology Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9148842423  
Fax    
Email  avanishbhardwaj78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramakrishna 
Designation  Junior Resident 1 ( post graduate trainee) 
Affiliation  Command Hoapital Air Force 
Address  Department of Anaesthesiology command hospital Air Force

Bangalore
KARNATAKA
560007
India 
Phone  7013548299  
Fax    
Email  ramakrishnarendla@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology at Command Hospital Air Force Bangalore  
 
Primary Sponsor  
Name  Commandant and Principal Command Hospital Air Force 
Address  Department of Anaesthesiology Command Hospital Air Force Bangalore 560007 
Type of Sponsor  Other [Command hospital , Air Force, Defence services] 
 
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 Ramakrishna  Dept of Anaesthesiology command hospital Airforce  2nd floor, department of Anaesthesiology, operation theatre from 1to 6 and post anaesthesia care unit
Bangalore
KARNATAKA 		 7013548299

ramakrishnarendla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Command Hospital , Air Force , Bangalore ,Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E078||Other specified disorders of thyroid, (2) ICD-10 Condition: J988||Other specified respiratory disorders, (3) ICD-10 Condition: C00-D49||Neoplasms, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (6) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (7) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DESFLURANE  Dose: 4-6% (to keep entropy values between 40-60) Route: Inhalational Frequency:Administered continuously through out THE surgery for maintenance of anaesthesia. Newer inhalational anaesthetic agents such as desflurane provide several advantages over the older inhalational agents and it was introduced in India after sevoflurane.Because of its pharmacological properties, desflurane may yield a rapid recovery and better quality of emergence when compared with sevoflurane and this effect may be more pronounced in the prolonged surgeries. 
Comparator Agent  SEVOFLURANE  Dose:0.5% to 3% ( to keep entropy value between 40 and 60) Route: Inhalational Frequency: Administered continuously throughout the surgery for maintenance of anaestheia. Sevoflurane is fluorinated methyl isopropyl ether with its name derived from having seven fluorine atoms in its substituents. It has a sweet odor and can be used in a conventional vaporizer. The MAC of sevoflurane is 1.8. Sevoflurane has rapid induction and emergence characteristics due to low blood: gas partition.The most frequently used inhalational anaesthetics these days are sevoflurane and desflurane, which differ in their pharmacokinetic properties and hence, could have different effects on post operative quality and time of recovery.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.ASA physical status Grade I ,II and III

2.Patients undergoing surgeries under General Anaesthesia lasting for more than 4 hours and planned for extubation after surgery 
 
ExclusionCriteria 
Details  1.Significant cardiovascular, respiratory, hepatic, renal, neurologic, psychiatric or metabolic disease,Craniotomies and cardiac surgeries
2.ASA Grade > III
3.Any complication leading to deviation from the proposed anaesthesia plan and likely to prevent proper assessment of study variables.
4.Documented allergic reaction to the anaesthetic agent being used.
5.Patient on chronic opioid analgesic or chronic use of alcohol.
6.Patient’s refusal to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Desflurane and Sevoflurane with regards to emergence and recovery characteristics in patients undergoing prolonged surgeries under General Anaesthesia by comparing the “Modified Aldrete Score” between the two groups at 15, 30, 45 and 60 minutes after extubation.   By comparing the “Modified Aldrete Score” between the two groups at baseline, 15, 30, 45 and 60 minutes after extubation.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Compare time to extubation, spontaneous eye opening and response to verbal commands after switching off the volatile agent.

2.Compare the incidence of laryngospasm, emergence hypertension and postoperative nausea vomiting with use of both the anaesthetic agents.
 		 At 15 min, 30 min, 45 min and 60 min after extubation 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/08/2021 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
PRIMARY PURPOSE OF THE STUDY : To compare Desflurane and Sevoflurane with regards to emergence and recovery characteristics in patients undergoing prolonged surgeries under General Anaesthesia by comparing the  “Modified Aldrete Score” between the two groups at 15, 30, 45 and 60 minutes after extubation.


STUDY HYPOTHESIS : Our Null hypothesis states that “There is no difference between Desflurane and Sevoflurane for emergence and recovery characteristics in adult patients undergoing prolonged surgeries under General Anaesthesia”. Alternative hypothesis is that “There is a difference in between Desflurane and Sevoflurane for emergence and recovery characteristics in adult patients undergoing prolonged surgeries under General Anaesthesia”. Taking results of other similar studies performed elsewhere into consideration, as per our review of relevant literature we expect the Modified Aldrete score in between the two groups to be more in the Desflurane group.


 
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