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临床试验/NCT05071794
NCT05071794已完成4 期

Effect of Propofol on Postoperative Nausea and Vomiting in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia.

Pakistan Air Force (PAF) Hospital Islamabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
postoperative nausea and vomiting

研究概览

简要总结

As PONV is an unpleasant experience that badly affects the patients' quality of life after surgery and the anti-emetic effects of propofol have been seldomly studied in Pakistan, this study aims at investigation of the beneficial effects of propofol in reducing the occurrence of PONV.

详细描述

Cesarean Section is one of the most commonly performed surgical procedures in the obstetric patients. Adequate intra and postoperative analgesia is very important in providing comfort to the mother, early breastfeeding, ambulation and discharge as well as enhancing patient satisfaction.Spinal anesthesia is widely accepted as the anesthesia of choice for cesarean section owing to its safety and speed. PONV is an unpleasant condition, often underestimated side effect of anesthesia and surgery, quite common in women undergoing spinal anesthesia for cesarean.It is one of the significant problems in Post Anaesthesia Care Units. The etiology of PONV is multifactorial with patient factors (gender, history of motion sickness, age), intra Op factors (type of anesthesia, surgery and opioid use) and post Op factors (pain, post Op opioid use) which are found to be associated with the PONV. Apfel simplified scoring is based on four independent factors including female gender, non-smoker, history of PONV or motion sickness and use of opioids. Each predictor is given a score of 1. A score of 0,1,2,3 or 4 predicts the chance of developing PONV as approximately 10%, 20%, 40% or 80%.

The intense efforts accompanying emesis increase the risk of complications such as wound dehiscence, bleeding, aspiration pneumonitis, dehydration, electrolyte imbalance and interference with nutrition. While it is difficult to completely avoid the occurrence of PONV, it can be markedly reduced using a multimodal non-opioid analgesia, total intravenous anesthesia and adequate prophylactic antiemetic premedication. Propofol has been reported to have anti-emetic effects at sub hypnotic dose as a bolus or a continuous infusion in susceptible individuals undergoing surgeries, though the exact mechanism of this effect is yet to be discovered.

In a research published in BMC Anesthesiology, the data indicates a significant difference in the incidence of PONV in control group (93.9%) and the study group (8.7%) with a single sub hypnotic dose of propofol administered 10-15 min before the end of surgery in parturients undergoing cesarean section under spinal anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • Parturient aged between 18 - 50 years
  • Elective Cesarean under spinal anesthesia
  • Patients at increased risk of PONV based on Apfel score 2 or more
  • ASA Class II
  • Ability to give informed consent

排除标准

  • Allergy to propofol
  • ASA Class III and above
  • Anti emetic drug administered 24 hrs prior to surgery

研究组 & 干预措施

Propofol

Active Comparator

Subhypnotic dose of propofol, 0.5mg/kg, 10 - 15 min before end of surgery

干预措施: Propofol (Drug)

Placebo

Placebo Comparator

Normal saline 0.9%, 10 mL , 10 - 15 min before end of surgery

干预措施: saline 0.9% (Drug)

结局指标

主要结局

postoperative nausea and vomiting

时间窗: 1 hour stay in Postanaesthesia Care Unit

Subjective complaint of nausea or any episode of vomiting

次要结局

未报告次要终点

研究者

发起方
Pakistan Air Force (PAF) Hospital Islamabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atif Nazir

Registrar Anesthesiologist

Pakistan Air Force (PAF) Hospital Islamabad

研究点 (1)

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