跳至主要内容
临床试验/CTRI/2024/05/068021
CTRI/2024/05/068021尚未招募4 期

A prospective randomized double blinded study - Effect of combined paracetamol and dexamethasone on post operative nausea and vomiting.

Lakshmi Priya R1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年6月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
incidence of post operative nausea and vomiting

研究概览

简要总结

Post operative nausea and vomiting (PONV) is one of the most

common distressed, with incidence ranging from 12-38%. The

pathophysiology of PONV is multifactorial; multiple pathways,

neurotransmitters, and risk factors are involved. Some of the

contributing factors for PONV include age < 50 years, female

gender, history of previous PONV or motion sickness,

nonsmoking, obesity, surgical- and anesthetic-related factors

like gastric inflation during mask ventilation, use of opioids and

nitrous oxide and/or parental anxiety.

The feelings associated with PONV are unpleasant and

distressful requiring multimodal treatment approaches. Recent

evidence indicated that inadequate prevention or treatment of

PONV potentiates prolonged recovery and hospitalization,

unpleasant hospital experiences, and increased health care

costs. For instance, prolonged vomiting may result in electrolyte

imbalance (hypocalcemia, hypochloremia, and hyponatremic

metabolic alkalosis) and dehydration, Mallory-Weis tears,

esophageal rupture, aspiration, wound dehiscence, increased

intracranial pressure, postoperative bleeding, and airway

obstruction especially in patients undergoing ENT surgery.

The use of antiemetics can reduce the occurrence of PONV

from over 52% to less than 30% in certain populations. To

decrease the incidence of PONV, a number of antiemetics

including antihistamines, butyrophenones, serotonin receptor

antagonists, corticosteroids, and anesthetic agents have been

tried in clinical use. Nevertheless, most of the antiemetics are

associated with undesirable adverse effects, such as sedation,

hypotension, dysphoria, dry mouth, restlessness, and

extrapyramidal symptoms.

Several studies have shown that dexamethasone, a

corticosteroid, is an effective antiemetic for PONV prophylaxis in

various types of surgery and in improving surgical outcomes.

Dexamethasone is an economical and efficacious antiemetic

drug with negligible side effects. Paracetamol is an analgesic or

anti-pyretic which can inhibit the activity of the cyclooxygenase

enzyme, which leads to inhibition of the prostaglandin production, equivalent to the NSAID.

The Primary objective of this study is to prove whether the

combination of paracetamol and dexamethasone is better

dexamethasone alone in preventing PONV. It is to find out if

paracetamol has any role in reducing PONV and can add to the

efficacy of dexamethasone in further reducing PONV.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 to 2
  • All Elective FESS surgery
  • All procedures done under General anaesthesia with a duration of less than 3 hours
  • Willingness to participate in the study.

排除标准

  • Patient’s refusal to give consent
  • Allergy to paracetamol, ondansetron
  • Emergency cases
  • ASA 3 and above
  • Patients requiring admission to the intensive care unit or mechanical ventilation
  • Patients with history of gastroesophageal reflux disorder, peptic ulcer disease, inflammatory bowel disease.
  • Patients with history of PONV, systemic diseases with nausea and vomiting
  • Patients requiring opioids in the post operative period.

结局指标

主要结局

incidence of post operative nausea and vomiting

时间窗: 1) incidence of nausea and vomiting is assessed from 1 minute | after induction till the entire surgery and 12 hours | post operatively | 2) severity of nausea and vomiting is assessed from 1 minute | after induction till the entire surgery and 12 hours | post operatively | 3) need for rescue antiemetics is assessed from 1 | minute after induction till the entire surgery and | 12 hours post operatively

次要结局

  • incidence of post operative pain(1) incidence of pain is assessed from 1 minute)

研究者

发起方
Lakshmi Priya R
申办方类型
Other [Self financing]
责任方
Principal Investigator
主要研究者

LAKSHMI PRIYA R

Sri Ramachandra Institute of Higher Education and Research, Porur

研究点 (1)

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