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临床试验/NCT03530007
NCT03530007Unknown2 期

Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section

Assiut University0 个研究点目标入组 120 人开始时间: 2018年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
120
主要终点
incidence of shivering

研究概览

简要总结

Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

详细描述

Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-65 years
  • Both sexes
  • American Society of Anesthesiologists
  • physical status I and II
  • scheduled for lower limb surgery under spinal anesthesia

排除标准

  • Uncooperative patients
  • psychologically unstable patients
  • obese patients with BMI >30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

研究组 & 干预措施

normal saline

Active Comparator

patients received normal saline for prevention of shivering during spinal anesthesia

干预措施: Normal saline (Drug)

ondansetron 4MG

Active Comparator

patients received 4 mg of ondansetron for prevention of spinal shivering

干预措施: Ondansetron 4 MG (Drug)

ondansetron 8MG

Active Comparator

patients received 8 mg of ondansetron for prevention of spinal shivering

干预措施: Ondansetron 8mg (Drug)

结局指标

主要结局

incidence of shivering

时间窗: for 24 hours after spinal anesthesia

Incidence of shivering among patients in both groups

次要结局

  • Axillary temperature(for 24 hours after spinal anesthesia)
  • incidence of nausea and vomiting(for 24 hours after spinal anesthesia)
  • core temperature(for 24 hours after spinal anesthesia)
  • incidence of hypotension(for 24 hours after spinal anesthesia)

研究者

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

Khaled Abdel-Baky Abdel-Rahman

lecturer

Assiut University

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