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临床试验/NCT07270289
NCT07270289尚未招募不适用

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

Assiut University0 个研究点目标入组 98 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
98
主要终点
Incidence of post operative neasea

研究概览

简要总结

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].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Incidence of post operative neasea

时间窗: 24 hours

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

incidance of postoperative vomting

时间窗: 24 hours

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

Incidence of post operative neasea

时间窗: 24 hours

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

incidance of postoperative vomting

时间窗: 24 hours

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ashraf kamel

Resident doctor at Anesthesia, Intensive Care and Pain Management

Assiut University

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