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CTRI Number  CTRI/2025/07/091912 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The Effect of Desflurane Switch at the End of Sevoflurane Based General Anaesthesia on Patient Emergence and Recovery 
Scientific Title of Study   The Impact of Desflurane Switch at the Conclusion of Sevoflurane Based General Anaesthesia on Patient Emergence and Recovery: A Randomized Controlled Trial 
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 Maria Clifson 
Designation  Principal Investigator 
Affiliation  MOSC Medical College Hospital, Kolenchery 
Address  2A Golden Dew Villas, Vennala High School Road, Vennala
Medical College Road, Kolenchery
Ernakulam
KERALA
682028
India 
Phone  9495362286  
Fax    
Email  drmariaclifson@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sam Philip 
Designation  Guide and Head of Department 
Affiliation  MOSC Medical College Hospital, Kolenchery 
Address  Department of Anaesthesia, MOSC Medical College Hospital, Medical College Road
Medical College Road, Kolenchery, 682311
Ernakulam
KERALA
682311
India 
Phone  9447209010  
Fax    
Email  drsam_p@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maria Clifson 
Designation  Principal Investigator 
Affiliation  MOSC Medical College Hospital, Kolenchery 
Address  2A Golden Dew Villas, Vennala High School Road, Vennala
Medical College Road, Kolenchery
Ernakulam
KERALA
682028
India 
Phone  9495362286  
Fax    
Email  drmariaclifson@gmail.com  
 
Source of Monetary or Material Support  
MOSC Medical College Hospital, Kolenchery, Medical College Road, Kolenchery, Kerala, India 682311 
 
Primary Sponsor  
Name  Dr Maria Clifson 
Address  Department of Anaesthesiology, MOSC Medical Coollege Hospital, Kolenchery, 682311 
Type of Sponsor  Other [Self] 
 
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 Maria Clifson  Operation theatre complex, Department of Anaesthesia   MOSC Medical College Hospital, Medical College Road, Kolenchery, Ernakulam, 682311
Ernakulam
KERALA 
9495362286

drmariaclifson@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MOSC Medical College Institutional Ethics Commiittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Desflurane  General anaesthesia lasting more than 2 hours with sevoflurane switched to desflurane in last 30mins 
Comparator Agent  Sevoflurane  General anaesthesia lasting more than 2 hours with sevoflurane 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists 1 and 2 patients undergoing elective surgeries lasting more than 2 hours under general anesthesia 
 
ExclusionCriteria 
Details  Patient refusal, Allergy to study drugs, Parturient, BMI more than 30, History or family history of malignant hyperthermia 
 
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 compare the eye opening time (the time when inhalational anaesthetic is stopped at the end of surgery till the patients first opened their eyes on verbal instruction) between sevoflurane and sevoflurane switched to desflurane  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time to reach Bispectral Index 80 after discontinuing the inhalational anaesthetic between sevoflurane and sevoflurane switched to desflurane  18 months 
To compare the time to endotracheal extubation (the time between stopping administration of inhalational anaesthetic to endotracheal tube removal after sufficient recovery) between sevoflurane and sevoflurane switched to desflurane  18 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   09/08/2025 
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 Applicable 
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  

Patients posted for surgeries requiring general anaesthesia lasting more than 2 hours with endotracheal intubation belonging to the age group of 18-65 years are selected for this study and will be divided into two separate groups, group A and group B consisting of 45 participants each.

The patient will be preoxygenated with a face mask, using 100% oxygen for 3 min followed by intravenous (IV) fentanyl (2 mcg/kg) and propofol (2 mg/kg) for anaesthesia induction. After the loss of consciousness, IV rocuronium (1 mg/kg) will be administered for attaining adequate muscle relaxation. Direct laryngoscopy and endotracheal intubation will be performed by an experienced anaesthesiologist using an appropriately sized endotracheal tube after 1 minute of rocuronium administration.  General anaesthesia is maintained with oxygen, air and sevoflurane to ensure a BIS level of 40–60. Adequate muscle relaxation is ensured during surgery using bolus doses of rocuronium by observing the TOF count.

In both groups, sevoflurane is used intraoperatively as an inhalation anaesthetic to maintain adequate depth of anaesthesia. Patients in Group-A will receive sevoflurane until the end of surgery, while those in Group B will be switched to desflurane 30 minutes before the end of surgery. 

At the end of the surgery, residual neuromuscular blockade will be reversed using IV sugammadex (2-4mg/kg) after assessing TOF count.

The eye-opening time will be measured at 10-s intervals from the point when sevoflurane or desflurane is stopped at the end of the surgery until the patient first open their eyes after verbal instructions from the anaesthesiologist. BIS at the time of eye opening is recorded. The time to removal of endotracheal tube and the time to reach BIS 80 after stopping sevoflurane and desflurane are also noted.

 
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