Effects of Combined Antiemetic Protocol For The Prevention Of Postoperative Nausea And Vomiting In Orthognathic Surgery: A Randomized Double Blinded Clinical Study
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
- 是
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
one group received granisetron 3 mg drug
干预措施: Intravenous drug (Drug)
Granisetron and Metoclopramide group
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
Özge Özyılmaz
Associate Professor
Bezmialem Vakif University
