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临床试验/NCT02736604
NCT02736604已完成不适用

Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
incidence and severity of post operative nausea and vomiting

研究概览

简要总结

Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant postoperative discomforts and lead to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is associated with significant morbidity. It may also result in delayed discharge, which is particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more susceptible to PONV than men and breast surgery, which is primarily done in an outpatient setting, is associated with high incidence of PONV, ranging between 15% and 84% in the absence of prophylactic treatment.

Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms: (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has been demonstrated to increase the incidence of PONV in some studies but not in others. The present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia on the undesirable clinical outcome of PONV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms

排除标准

  • ASA III, IV, V female patients
  • Age less than 18 years
  • Patients undergoing Breast Reconstructive Surgery
  • Patients with contraindications to Fentanyl, Diclofenac, Paracetamol, Atracurium
  • Chronic pain patients on long-term opioid medication
  • Use of regional anesthetic technique (e.g. Paravertebral Block)

研究组 & 干预措施

Air anesthesia

Experimental

air will be used as carrier agent for maintenance of anesthesia

干预措施: air anesthesia (Drug)

Air anesthesia

Experimental

air will be used as carrier agent for maintenance of anesthesia

干预措施: laryngeal mask airway (LMA Supreme Size 3/4 (Device)

Air anesthesia

Experimental

air will be used as carrier agent for maintenance of anesthesia

干预措施: sevoflurane (Drug)

Nitrous Oxide anesthesia

Active Comparator

nitrous oxide will be used as carrier agent for maintenance of anesthesia

干预措施: nitrous oxide anesthesia (Drug)

Nitrous Oxide anesthesia

Active Comparator

nitrous oxide will be used as carrier agent for maintenance of anesthesia

干预措施: laryngeal mask airway (LMA Supreme Size 3/4 (Device)

Nitrous Oxide anesthesia

Active Comparator

nitrous oxide will be used as carrier agent for maintenance of anesthesia

干预措施: sevoflurane (Drug)

结局指标

主要结局

incidence and severity of post operative nausea and vomiting

时间窗: up to 24 hours after surgery

Patients will be followed for 24 hours post-surgery or discharge from hospital whichever is earlier. postoperative nausea and vomiting intensity scale will be used to assess incidence and severity of nausea and vomiting.

次要结局

  • measurement of pain score and analgesic requirements(up to 24 hours after surgery)
  • Airway device cuff pressures(During the surgery)

研究者

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

Vijaya P Patil

professor and Anaesthetist

Tata Memorial Hospital

研究点 (1)

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