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临床试验/NCT06454825
NCT06454825已完成4 期

Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年4月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Postoperative nausea and vomiting

研究概览

简要总结

In an effort to prevent or treat consistently high rates of PONV following maxillofacial operations, several medications, techniques and multimodal protocols have been studied. In the present study, the investigators hypothesized that combining metoclopramide with granisetron will improve PONV incidence when compared with granisetrone alone.

详细描述

Despite advances in anesthetic techniques and antiemetic drugs that accompany increasing awareness of anesthesia providers, postoperative nausea and vomiting (PONV) remains one of the most common problems after general anesthesia. PONV is one of the major problems leading to patient dissatisfaction, prolonged stay in postoperative care unit and hospital, readmissions and thus it can increase health care costs. In the studies performed in PONV prone patients and high-risk surgeries, as compared with other antiemetic medications, "setrons" provided lower nausea and vomiting incidence postoperatively, but were unable to completely prevent this "big little" problem.The blood in the stomach has been indicated as one of the major causes of PONV following maxillofacial surgery thus, using metoclopramide may relieve the complaints by evacuating this irritant. After institutional ethic committee and National Medicines, 66 consecutive patients, classified as ASA I and II physical status and aged between 18 and 60 years were included in the study. Apfel's simplified PONV risk score including female sex, history of motion sickness or PONV, smoking status and predicted use of postoperative opioids was recorded.Procedures were performed under general anesthesia. Patients in Group G received 3 mg granisetron (Neoset, Deva, Istanbul) and the patients in group GM received 3 mg granisetron + 10 mg metoclopramide (Metpamid, Sifar İlaç, Istanbul) 30 minutes before the end of operation intravenously. A nursing staff collected the data concerning PONV, VAS, systolic, diastolic and mean arterial pressures, heart rate, peripheral arterial saturation, total doses of drugs used, overall bleeding score, infused fluid volume, VAS, surgical procedure, duration of surgery and rescue antiemetics for nausea if applied for 24 hours.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • Undergoing orthognathic surgery
  • ASA I and II physical status
  • aged between 18 and 60 years
  • must be volunteer to take study drugs

排除标准

  • Unable or unwilling to give informed consent
  • Underwent to genioplasty
  • Documented hypersensitivity to study drugs
  • Gastroesophageal reflux or hiatal hernia
  • Diabetes mellitus
  • Renal insufficiency
  • Pregnancy
  • Electrolyte imbalance
  • Neurological disease
  • Mental retardation
  • Prolonged QT interval.

研究组 & 干预措施

Granisetron group

Active Comparator

one group received granisetron 3 mg drug

干预措施: Intravenous drug (Drug)

Granisetron and Metoclopramide group

Experimental

one group received a combination of granisetron 3 mg and metoclopramide 10 mg drugs

干预措施: Intravenous drug (Drug)

结局指标

主要结局

Postoperative nausea and vomiting

时间窗: fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively

The primary outcome of interest in the present study was the incidence of PONV.

次要结局

  • Infused fluid volume(before extubation)
  • Diastolic arterial pressure(preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.)
  • total doses of drugs(before extubation)
  • Visual analogue scale(fully awake and on the 1st, 2nd, 4th, 6th , 8th and 24th hours postoperatively)
  • Systolic arterial pressure(preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.)
  • Mean arterial pressure(preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.)
  • peripheral arterial saturation(preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.)
  • Duration of surgery(before extubation)
  • heart rate(preoperatively, at the induction, every 30 minutes interval till the end of the surgery, before extubation.)
  • Bleeding amount(before extubation)
  • Rescue antiemetic(it was recorded until follow-up period ended and if applied it would be recorded. Between fully awake in ward and 24th hours postoperatively.)

研究者

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

Özge Özyılmaz

Associate Professor

Bezmialem Vakif University

研究点 (1)

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