| CTRI Number |
CTRI/2025/11/098070 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between Desflurane Versus Sevoflurane On Post Operative Recovery Profile And Airway Reflexs |
|
Scientific Title of Study
|
Comparison Of Efficacy Among Desflurane Versus Sevoflurane On Post Operative Recovery Profile And Airway Reflexs In Patients Under Going 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 |
Dr Anita Pareek |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner, Rajasthan, India |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner, Rajasthan, India
Bikaner RAJASTHAN 334001 India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anita Pareek |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner, Rajasthan, India |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner, Rajasthan, India
Bikaner RAJASTHAN 334001 India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anita Pareek |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner, Rajasthan, India |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner, Rajasthan, India
Bikaner RAJASTHAN 334001 India |
| Phone |
9828101281 |
| Fax |
|
| Email |
dranitapareek23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia SPMC bikaner |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner |
| Address |
Department Of Anaesthesia Sardar Patel Medical College Bikaner |
| Type of Sponsor |
Government medical college |
|
|
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 Aditya Kishore |
OT A block, Department Of Anaesthesia |
Department Of Anaesthesia Sardar Patel Medical College Bikaner RAJASTHAN |
09855491027
10adityakishore10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SPMC MEDICAL COLLEGE BIKANER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desflurane versus sevoflurane |
post operation recovery
and airway reflexs |
| Intervention |
direct laryngoscopy and tracheal intubation |
intra inhalational anaesthic agents |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 Or 2
Elective surgery requiring General Anaesthesia
Written Informed Consent by Patients |
|
| ExclusionCriteria |
| Details |
BMI more than 35 kg/m2
Difficult Intubation
Respiratory Diseases
Preganacy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recovery Profile Evaluation
Airway Reflexes Assessment |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamics Variables
Post Anaesthesia Complications
Patient Satisfaction
|
60 min post op |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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="0" 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
|
For general anaesthesia,
volatile anaesthetics like desflurane and sevoflurane are frequently employed
due to their predictability, ease of use and medicinal outcomes. Sevoflurane is
frequently used to maintain anaesthesia during day care surgery because of its
quick emergence and recovery and comparatively reduced blood gas solubility
when compared to other volatile anaesthetics. Furthermore,
sevoflurane is frequently employed as an induction agent since it does not
irritate the airways, resulting in smooth volatile induction. Since desflurane
is the least blood gas soluble of the volatile anaesthetics in the market right
now, it’s emergence and recovery are more quickly than sevoflurane.
Furthermore, emergence and recovery are linked to desflurane use that is more
predictable than sevoflurane. To enable quick
and simple anaesthetic induction, dependable intra-operative analgesia, and amnesia,
novel medications are used in anaesthesia. Inhalational and volatile liquid
anaesthetics are gaining popularity because of how simple it is to administer
them and because of how consistently they emerge and recover. Contrary to usual
inhalational anaesthetics, desflurane and sevoflurane have low blood-gas
partition coefficients. If the patient wakes up more quickly, less
time will be spent in the post-anaesthesia care unit and with their airway
exposed. The quality of emergence and rate of recovery are impacted by the
anaesthetic method chosen. The best general anaesthesia should result in a
painless induction, the best possible operating conditions, and a speedy
recovery with the fewest possible side effects, such as nausea, vomiting, and
postoperative discomfort. Desflurane and
sevoflurane, two inhaled general anaesthetics, are used the most frequently due
to their simplicity of administration and consistent intraoperative and
recovery characteristics. Rapid recovery minimises postoperative respiratory
complications and ensures early, effective coughing. Sevoflurane has quick
induction and emergence characteristics and a low blood:gas partition
coefficient. Studies
comparing desflurane and sevoflurane anaesthesia with laryngeal mask airway
(LMA) have shown similar rates of: Respiratory illness, with desflurane
allowing for faster recovery Gag reflex after emergence, compared with
sevoflurane. Some studies
reported that desflurane has a consistent and rapid recovery profile in the
obese population compared to sevoflurane, isoflurane and propofol. Verma et al in their study concluded patients in the three groups had similar impairments
in their psychomotor and cognitive functions which recovered at comparable time
periods postoperatively. Emergence and early recovery were, however, faster in
the desflurane group. Desflurane is known to have a rapid onset and offset of action, thereby
making it possible for the anaesthesiologist to control the depth of
anaesthesia rapidly. It also provides haemodynamic stability with preservation
of tissue perfusion even in face of hypotension; however it is irritating to
the airway and therefore is not routinely utilised for inhalational induction. However, studies have shown that controlled desflurane induction along with opioid
premedication can be rapid and well tolerated. Sevoflurane
administration has been associated with a smooth, rapid loss of consciousness
during inhalation induction and a rapid recovery following discontinuation of
anaesthesia. In the present study, a comparison of efficacy
between desflurane and sevoflurane will be done to assess postoperative
recovery characteristics in patients undergoing general anaesthesia. |