| 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
|
|
|
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
|
|
|
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. |