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临床试验/NCT03483350
NCT03483350Unknown3 期

Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children

Assiut University0 个研究点目标入组 90 人开始时间: 2018年3月最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
90
主要终点
Vomiting score

研究概览

简要总结

Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.

The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons.

详细描述

Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients.

The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons. The CRTZ receives input from vagal afferents in the gastrointestinal tract, and it can also detect emetogenic toxins, metabolites, and drugs circulating in the blood and cerebrospinal fluid due to its lack of the bloodbrain barrier. Multiple neurotransmitter pathways are implicated in the physiology of nausea and vomiting. Enterochromaffin cells in the gastrointestinal tract release serotonin, and the vagus nerve communicates with the CRTZ via 5-HT3 receptors. The CRTZ communicates with the NTS primarily via dopamine-2 (D2) receptors.

PONV may increase hospital expenditure by prolongation of hospital stay, and management of vomiting related complications such as dehydration, electrolyte disturbances, and pulmonary aspiration. Pediatric laparoscopic surgery is commonly associated with higher incidence of PONV. Mixtures of different classes of antiemetics have been used successfully to decrease the incidence of PONV but there was no agreement on the optimal combination. Granisetron a newer 5-HT3 antagonist has stronger receptor binding and has been found to be more potent and longer acting as antiemetic for preventing postoperative nausea and vomiting following laparoscopic surgery. Midazolam is commonly used as a premedication to relief anxiety. Midazolam given intravenously before the end of surgery was effective in decreasing the incidence of PONV. sub-hypnotic dose of midazolam was suggested that have a role in the management 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
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • This study will include children, scheduled for elective Laparoscopic surgery
  • Age 4-12 years
  • ASA I or II

排除标准

  • Patients will be excluded who meet these criteria
  • Patient refusal
  • Any contraindication of laparoscopic surgery;as personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, liver disease, renal dysfunction and cardiac conduction abnormalises
  • Known allergy to the drugs included in the study

研究组 & 干预措施

1- 1st group

Experimental

1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery

干预措施: Granisetron (Drug)

2- 2nd

Experimental

2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery

干预措施: Midazolam (Drug)

3- 3rd group

Experimental

3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery

干预措施: Granisetron (Drug)

3- 3rd group

Experimental

3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery

干预措施: Midazolam (Drug)

结局指标

主要结局

Vomiting score

时间窗: for48hours(two day)

Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time

次要结局

  • Nausea score(for48hours(two day))

研究者

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

Wesam Nashat Ali

Lecturer of anesthesiology Assiut University

Assiut University

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