Home » Trials » SLCTR/2025/039
Impact of Isoflurane and Desflurane on Recovery Time and Postoperative Nausea in Patients Undergoing Laparoscopic Cholecystectomy
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SLCTR Registration Number
SLCTR/2025/039
Date of Registration
The date of last modification
Oct 02, 2025
Scientific Title of Trial
Impact of Isoflurane and Desflurane on Recovery Time and Postoperative Nausea in Patients Undergoing Laparoscopic Cholecystectomy
Public Title of Trial
What is the effect of isoflurane compared to desflurane on recovery time and post operative nausea in patients undergoing laparoscopic cholecystectomy?
Disease or Health Condition(s) Studied
Postoperative nausea and vomiting, Laparascopic cholecystectomy
Scientific Acronym
None
Public Acronym
None
Brief title
Isoflurane vs. Desflurane: Effects on Recovery and Nausea After Laparoscopic Cholecystectomy
Universal Trial Number
U1111-1317-9971
Any other number(s) assigned to the trial and issuing authority
IRB Approval 13/Trg/83/2024
What is the research question being addressed?
What is the effect of isoflurane compared to desflurane on recovery time and postoperative nausea in patients undergoing laparoscopic cholecystectomy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Phase 2-3
Intervention(s) planned
Study setting: Combined Military Hospital Multan
Method of randomization into study arms: Simple randomization Unit of randomization: Individual Patient
Method of sequence generation: Computer-generated randomization
A total of 110 patients aged 18 years and above undergoing planned laparoscopic cholecystectomy will randomized into two equal groups of 55 patients each.
Intervention: Isoflurane, Dose: 1.2–1.5 MAC (Minimum Alveolar Concentration) Route: inhalational, used for anesthesia maintenance, given for the duration of the intraoperative period, as continuous maintenance until surgery completion).
Control: Desflurane Dose: 1.3–1.5 Minimum Alveolar Concentration (MAC) Route: inhalational, used for anesthesia maintenance, given for the duration of
the intraoperative period, as continuous maintenance until surgery completion).
Induction protocol for both groups: vi. Midazolam 0.02 mg/kg IV (premedication) vii. Propofol 2 mg/kg IV (induction) viii. Fentanyl 2 µg/kg IV (analgesia) ix. Rocuronium 0.6 mg/kg IV (muscle relaxation and intubation) x. Standard monitoring during and after procedure Participants will be blinded to the intervention status
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Postoperative recovery time The Modified Aldrete Scoring system will be used. A score of ?9 will be used as a reference to discharge the patient from the Post-anesthesia Care Unit, and the time from discontinuation of anesthetic agent to discharge will be measured |
[ Till time of discharge ] |
|
2.
Incidence of postoperative nausea and vomiting within the first 24 hours postoperatively. |
[ Incidence of the episode of vomiting and nausea will be recorded during the early (0-6 hours) and late phase (6-24 hours). ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
110 (55 in each arm)
Countries of recruitment
Pakistan
Anticipated start date
2025-10-06
Anticipated end date
2026-03-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Investigator funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-04-04
Approval number
13/Trg/83/2024
Details of Ethics Review Committee
| Name: | Institutional Review Board & Ethical Committee CMH Multan Institute of Medical Sciences |
| Institutional Address: | Ghaus ul Azam Road? near Naseem Hayat Rd, Pia Colony, Multan, Punjab, Pakistan |
| Telephone: | (061) 9201703 |
| Email: | administration@cims.pk |
Contact person for Scientific Queries/Principal Investigator
Inshal Jawed
General Physician
Mission Rd, New Labour Colony Nanakwara, Karachi, Karachi City, Sindh, Pakistan
+92 341 2636484
inshaljwd@gmail.com
Contact Person for Public Queries
Inshal Jawed
General Physician
Mission Rd, New Labour Colony Nanakwara, Karachi, Karachi City, Sindh, Pakistan
+92 341 2636484
inshaljwd@gmail.com
Primary study sponsor/organization
Inshal Jawed
General Physician
Mission Rd, New Labour Colony Nanakwara, Karachi, Karachi City, Sindh, Pakistan
+92 341 2636484
inshaljwd@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
