Total Intravenous Anesthesia (TIVA) Versus Inhalational Anesthesia at The End of Laparoscopic Obstetric Surgery Regarding Postoperative Nausea and Vomiting

NCT ID: NCT07270289

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

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].

Conditions

Laparoscopic Obstetric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

inhalational anaesthesia

Intervention Type: PROCEDURE

patients will be offed from inhalational anesthesia

total intravenous anesthesia (TIVA)

Intervention Type: PROCEDURE

patients will be Switched Total Intravenous Anesthesia (TIVA)

Group B

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

Group Type: ACTIVE_COMPARATOR

inhalational anaesthesia

Intervention Type: PROCEDURE

patients will be offed from inhalational anesthesia

Interventions

inhalational anaesthesia

patients will be offed from inhalational anesthesia

Intervention Type: PROCEDURE

total intravenous anesthesia (TIVA)

patients will be Switched Total Intravenous Anesthesia (TIVA)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ashraf kamel

Resident doctor at Anesthesia, Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

tiva vs inhala anesth in ponv

Identifier Type: -

Identifier Source: org_study_id