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临床试验/NCT04461093
NCT04461093已完成不适用

Comparison of the Efficacy of Acupressure P6 Point, Dexamethasone and Ondansetron Versus Palonosetron Monotherapy for Preventing Postoperative Nausea and Vomiting in Laparoscopic Surgery

Mohd Zulfakar Mazlan, MBBS4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
The incidence of postoperative nausea and vomiting immediately, at

研究概览

简要总结

Postoperative nausea and vomiting (PONV) is defined as nausea and/or vomiting occurring within 24 hours after surgery, it commonly affects 20-30% patients but as high as 70-80% patients who are deemed high risk for PONV may be affected. PONV may cause unpleasant complications such as dehydration, electrolyte imbalance, suture dehiscence, aspiration of gastric contents, delayed recovery and prolonged hospital stay. Standard guideline recommended combination of anti-emetics to prevent PONV in high risk patients. The commonly used agents are dexamethasone and ondansetron which are cheaper although they are proven to be less effective as single agent when compared with newer agent such as palonosetron. As an adjunct or alternative to pharmacological treatment, acupressure P6 point has gained increasing attention for its possible value in preventing PONV. It is proven that acupressure reduced the incidences of PONV when combined with pharmacological treatment. It is postulated that acupressure active Aβ and Aδ fibres and stimulate the release of β-endorphine from hypothalamus. In addition, it is believed that acupressure might act on dopaminergic, serotonergic and norepinerphrinergic fibres which might has a role in PONV prevention.

详细描述

This study is designed to compare the efficacy of palonosetron monotherapy versus combination of acupressure P6 point with dexamethasone and ondansetron in preventing PONV. It has been proven that palonosetron is more superior as single agent when compared with acupressure, dexamethasone and ondansetron separately. However, this might not be cost effective as palonosetron is more expensive than the other agents. In addition, the combination therapy has been reported better in preventing PONV when compared with monotherapy. The investigators need to investigate whether the combination of acupressure with dexamethasone and ondansetron exert an effect equal or even better than palonosetron monotherapy. The investigators hypothesis is the combination of acupressure P6 point with dexamethasone and ondansetron provide better prophylaxis againts PONV when compared with palonosetron. The requirement for rescue anti-emetics for combination of acupressure P6 point with dexamethasone and ondansetron group is lesser than palonosetron.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Potential patients are identified and consented for study during pre-operative assessment. Both patients and assessors are blinded in this trial.

Participants and assessors are being blinded of the treatment or medications given intra-operatively. The acupressure wristband and anti-emetics will be given after general anaesthesia. The wristband will be removed prior to emergence, participants will not aware of the methods used to prevent nausea and vomiting. Postoperative participants will be assessed by independent nurses who are not involved in the study.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I or II female patients aged 18 - 65 years old in view female patients are at higher risk of postoperative nausea and vomiting.
  • Patients undergoing laparoscopic surgery.
  • High risk for PONV (APFEL score 3-4).

排除标准

  • Patients with known allergic to dexamethasone, ondansetron and wristband.
  • Patients who take anti-emetic, emetogenic drugs and glucocorticoids within 24 hours before surgery.
  • Patients with upper limb disability which affect the application of wristband.
  • Obese patients with BMI > 35 in view acupressure P6 wristband might be too tight to fit patient's wrist which might affect the correct placement of pressure point.
  • Pre-existing vertigo

结局指标

主要结局

The incidence of postoperative nausea and vomiting immediately, at

时间窗: Hours 48, postoperative

次要结局

  • The proportion of patients require rescue anti-emetics immediately,(Hours 48, postoperative.)

研究者

发起方
Mohd Zulfakar Mazlan, MBBS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohd Zulfakar Mazlan, MBBS

Comparison of the efficacy of acupressure P6 point, dexamethasone and ondansetron versus palonosetron monotherapy for preventing postoperative nausea and vomiting in laparoscopic surgery

Universiti Sains Malaysia

研究点 (4)

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