A prospective randomized double blinded study - Effect of combined paracetamol and dexamethasone on post operative nausea and vomiting.
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
LAKSHMI PRIYA R
Sri Ramachandra Institute of Higher Education and Research, Porur
