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CTRI Number  CTRI/2024/06/068859 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
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 recovery profile of desflurane vs sevoflurane in FESS surgery  
Scientific Title of Study   Comparison of recovery profile of Desflurane Vs Sevoflurane in patients undergoing FESS surgery under General Anaesthesia  
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Birva Khara 
Designation  Professor 
Affiliation  Pramukh Swami Medical College,Bhaikaka university  
Address  Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  9537122077  
Fax    
Email  Birvank@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreyani Chaudhari  
Designation  Resident Doctor, Department of Anesthesiology  
Affiliation  Pramukh Swami Medical College , Bhaikaka University  
Address  Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  8758562489  
Fax    
Email  cshreyanee@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreyani Chaudhari  
Designation  Resident Doctor, Department of Anesthesiology  
Affiliation  Pramukh Swami Medical College,Bhaikaka university 
Address  Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad

Anand
GUJARAT
388325
India 
Phone  8758562489  
Fax    
Email  cshreyanee@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology Shree Krishna Hospital Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand Gujarat,India,PIN CODE 388325 
 
Primary Sponsor  
Name  Shree Krishna Hospital Anand  
Address  Karamsad, Anand, Gujrat ,India ,Pin code 388325 
Type of Sponsor  Private medical college 
 
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 Birva Khara  Pramukh Swami Medical College   Department of anaesthesiology, Pramukh Swami Medical College Anand GUJARAT
Anand
GUJARAT 
9537122077

Birvank@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaikaka University,Kar amsad,Anand,Gujarat-3 88325  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   In Group D patients, anaesthesia will be maintained with oxygen, air and Desflurane through closed circuit via mechanical ventilation till end of surgery. 
Comparator Agent  Sevoflurane   in Group S patients anaesthesia will be maintained with oxygen, air and Sevoflurane through closed circuit via mechanical ventilation till end of surgery. 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients of all age group undergoing FESS surgery under general anaesthesia. 
 
ExclusionCriteria 
Details  1)Patients having history of mental dysfunction
2)Discontinuation of inhalation agent intraoperatively due to severe hypotension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate the recovery profile in patients undergoing FESS surgery under general anaesthesia  post operative period 0 to 6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   24/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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   Patient undergoing FESS surgery under general anesthesia will be recruited to participate in this study.
In group D Desflurane will be used as inhalation agent and In group S Sevoflurane willbe used as inhalation agent.
Preoperative assessment will be done and written informed consent will be obtained from all the patients who fulfil the inclusion criteria. Patients will be randomly assigned to any one of the two groups. In the preoperative room, after confirming the NBM hours and checking the vitals, both the groups will receive loading dose of injection Dexmedetomidine 1 mcg/kg over 20 minutes in preoperative room and continued intraoperatively in the dose of 0.2mcg-0.7mcg/kg/hr according to hemodynamics. In the operation theatre, after attaching monitors, premedication with injection Fentanyl 2 mcg/kg and injection Loxicard 2% 1.5 mg/kg intravenously will be given before the procedure. Induction for both groups will be achieved by Injection Propofol 2 mg/kg iv . After performing check ventilation, succinyl choline 2 mg/kg will be administered intravenously to both groups to aid in intubation. Oral intubation will be done with PC ETT of appropriate size through conventional laryngoscope. Intermediate muscle relaxation will be achieved with Vecuronium 0.1 mg/kg. Throat pack will be inserted. For maintenance of anaesthesia, In Group D patients, anaesthesia will be maintained with oxygen, air and Desflurane, and in Group S patients anaesthesia will be maintained with oxygen, air and Sevoflurane. Intraoperative muscle relaxation will be maintained with Vecuronium 0.05 mg/kg. The initial inspired concentration of desflurane and sevoflurane will be adjusted to maintain MAP value less than 20% of baseline value . Oxygen saturation and end tidal carbon dioxide values will be monitored continuously. Heart rate, blood pressure will be recorded every 5 min during surgery. Injection ondansetron 4 mg and Injection Paracetamol 1 gm iv will be given at end of surgery. Sevoflurane/desflurane will be discontinued at the end of surgery and time will be noted, throat pack will be removed and 100% oxygen will be delivered. Residual neuromuscular blockade will be reversed using Glycopyrrolate 0.01mg/kg iv and Neostigmine 0.05 mg/kg iv. 
The times from discontinuing inhalation agent to eye opening, tracheal extubation, obeying verbal commands, as well as the time to orientation to name will be assessed at 30-60 s intervals. The duration of anesthesia and surgery will be recorded.
On arrival in recovery room, heart rate, blood pressure and oxygen saturation will be monitored until the patient is fully awake. If required iv analgesic will be given for post operative pain relief. The modified Aldrete scoring system will be used to access recovery from anesthesia.The modified Aldrete scores will be evaluated every 10 min after arrival in recovery room for the first half hour then every 15 or 30 mins until discharge. The time to achieve modified Aldrete Score >9 after discontinuation of the inhalation agent will be noted.
 
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