Laparoscopic Obstetric SurgeryNCT07270289
Total Intravenous Anesthesia (TIVA) Versus Inhalational Anesthesia at The End of Laparoscopic Obstetric Surgery Regarding Postoperative Nausea and Vomiting
A study testing inhalational anaesthesia and total intravenous anesthesia (TIVA) in people with Laparoscopic Obstetric Surgery, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Laparoscopic Obstetric Surgery
- What is being tested?
- inhalational anaesthesia and total intravenous anesthesia (TIVA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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].
Read more
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].
- Conditions
- Laparoscopic Obstetric Surgery
- Being tested
- inhalational anaesthesia, total intravenous anesthesia (TIVA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalational anaesthesiaProcedure or surgery
patients will be offed from inhalational anesthesia
total intravenous anesthesia (TIVA)Procedure or surgery
patients will be Switched Total Intravenous Anesthesia (TIVA)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | patients will be offed from inhalational anesthesia and Switched to propofol TIVA for the final 10 minutes of surgery Receives: Procedure: inhalational anaesthesia; Procedure: 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. Receives: Procedure: inhalational anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative neasea
Any episode of nausea (NRS ≥ 4/10 or requiring treatment)
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Obstetric SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270289
- Sponsor's protocol ID
- tiva vs inhala anesth in ponv
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia (TIVA) Versus Inhalational Anesthesia at The End of Laparoscopic Obstetric Surgery Regarding Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07270289
- Acronym / sponsor ID
- tiva vs inhala anesth in ponv
- Conditions
- Laparoscopic Obstetric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: inhalational anaesthesia, Procedure: total intravenous anesthesia (TIVA)patients will be offed from inhalational anesthesia and Switched to propofol TIVA for the final 10 minutes of surgery |
| Group B | Active comparator | Procedure: inhalational anaesthesiapatients will be Continued on inhalational anaesthesia (sevoflurane or isoflurane per protocol)during the same final phase through extubation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhalational anaesthesiapatients will be offed from inhalational anesthesia | Procedure or surgery | Group A, Group B |
| total intravenous anesthesia (TIVA)patients will be Switched Total Intravenous Anesthesia (TIVA) | Procedure or surgery | Group A |
Primary outcome
Incidence of post operative neasea
Time frame: 24 hours
Any episode of nausea (NRS ≥ 4/10 or requiring treatment)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing inhalational anaesthesia and total intravenous anesthesia (TIVA) in people with Laparoscopic Obstetric Surgery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post operative neasea (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.