NCT07270289

Brief Summary

Postoperative nausea and vomiting (PONV) remain among the most common and distressing complications after general anaesthesia, with important consequences for patient comfort, satisfaction, recovery trajectories, and length of stay following surgery. The incidence of PONV is especially high after laparoscopic and gynaecological procedures due to patient- and procedure-related risk factors, making effective prevention and management a priority in perioperative care \[5,8\]. Anaesthetic technique is a recognized, modifiable determinant of PONV. Numerous clinical trials and randomized studies have demonstrated that the choice between propofol-based total intravenous anaesthesia (TIVA) and volatile inhalational maintenance can materially influence PONV incidence. Propofol-based TIVA has been repeatedly associated with lower rates of early and overall PONV compared with volatile agents in diverse surgical populations, supporting its role as an antiemetic strategy in addition to pharmacologic prophylaxis \[1,2,4,9\]. Trials specifically conducted in gynaecological and laparoscopic surgical populations report consistent reductions in nausea and vomiting with propofol maintenance compared with isoflurane or other volatile agents. These procedure-specific data are directly relevant to studies in gynecological laparoscopy, where baseline PONV risk is elevated and where anesthetic technique may yield a clinically meaningful reduction in patient morbidity \[5,8,9\]. Meta-analyses and systematic reviews pooling randomized controlled trials provide higher-level evidence that TIVA reduces the relative risk of PONV compared with volatile anaesthesia. Trial-sequential and pooled analyses estimate a clinically important risk reduction favoring TIVA, although effect sizes vary with study populations, prophylactic antiemetic regimens, and outcome time windows; these syntheses underpin the rationale for a targeted randomized comparison in the gynecological laparoscopic setting \[2,4,10\].

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of post operative neasea

    Any episode of nausea (NRS ≥ 4/10 or requiring treatment)

    24 hours

  • incidance of postoperative vomting

    any episode of vomiting/retching recorded at 0-2, 2-6, and 6-24 h; need for rescue antiemetic

    24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients will be offed from inhalational anesthesia and Switched to propofol TIVA for the final 10 minutes of surgery

Procedure: inhalational anaesthesiaProcedure: total intravenous anesthesia (TIVA)

Group B

ACTIVE COMPARATOR

patients will be Continued on inhalational anaesthesia (sevoflurane or isoflurane per protocol)during the same final phase through extubation.

Procedure: inhalational anaesthesia

Interventions

patients will be offed from inhalational anesthesia

Group AGroup B

patients will be Switched Total Intravenous Anesthesia (TIVA)

Group A

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female, age 18-50 years.
  • Elective laparoscopic procedure under general anaesthesia with endotracheal intubation.
  • Expected surgical duration ≥ 30 minutes. -.Ability to consent and complete questionnaires

You may not qualify if:

  • Pregnancy or lactation.
  • BMI ≥ 40 kg/m²; severe cardiopulmonary disease; hepatic/renal failure.
  • History of malignant hyperthermia or contraindication to study drugs.
  • Known allergy to propofol, , , sevoflurane/desflurane.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at Anesthesia, Intensive Care and Pain Management

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 8, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 8, 2025

Record last verified: 2025-11