- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07270289
Total Intravenous Anesthesia (TIVA) Versus Inhalational Anesthesia at The End of Laparoscopic Obstetric Surgery Regarding Postoperative Nausea and Vomiting
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].
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
patients will be offed from inhalational anesthesia and Switched to propofol TIVA for the final 10 minutes of surgery
|
patients will be offed from inhalational anesthesia
patients will be Switched Total Intravenous Anesthesia (TIVA)
|
|
Active Comparator: Group B
patients will be Continued on inhalational anaesthesia (sevoflurane or isoflurane per protocol)during the same final phase through extubation.
|
patients will be offed from inhalational anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of post operative neasea
Time Frame: 24 hours
|
Any episode of nausea (NRS ≥ 4/10 or requiring treatment)
|
24 hours
|
|
incidance of postoperative vomting
Time Frame: 24 hours
|
any episode of vomiting/retching recorded at 0-2, 2-6, and 6-24 h; need for rescue antiemetic
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- tiva vs inhala anesth in ponv
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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