To observe the efficacy of intravenous amisulpride for the prevention of postoperative nausea and vomiting in patients undergoing surgeries under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To observe the incidence of post operative nausea and vomiting in patients undergoing elective or emergency surgery under general anaesthesia
研究概览
简要总结
After obtaining institutional ethics committee approval and written and informed consent from patients of ASA I, II or III who will be undergoing surgery under general anaesthesia will be included in this study. Preanaesthetic check-up will be carried out in all patients.
Patients will be kept Nil by mouth(NBM) for 8 hours for solids and 2 hrs for clear liquid before surgery.Appropriate fluids will be started in preoperative room and will be continued in the operation theatre (OT). After the patient is taken in the operating room, monitors like Pulse oximetry, electrocardiogram, non invasive blood pressure monitoring, manual blood pressure monitoring and end tidal carbon dioxide monitoring device will be applied and hemodynamic variables will be measured on arrival to the OT and every 5 min thereafter till the end of surgery.
Standard anesthesia technique for induction of general anesthesia will be used. Patients will be premedicated with injection midazolam, fentanyl, xylocard as per protocol and intravenous amisulpride 5 mg will be given. Patients will be induced with propofol and with or without muscle relaxation as per the case. General anaesthesia will be given by Endotracheal Tube/ IGEL/ LMA. Anesthesia will be maintained by O2,AIR and Sevoflurane/ Desflurane. End-tidal CO2 will be maintained between 35 and 40 mm of Hg. Pulse rate, electrocardiogram, NIBP, and oxygen saturation will be monitored continuously throughout the procedure. At the end of procedure if the patient will be given non depolarizing muscle relaxant neuromuscular blockade will be reversed with Inj.neostigmine and Inj.glycopyrolate. Before extubation as per the standard protocol Inj paracetamol 1gm(100ml)will be given.After extubation, patients will be shifted to recovery room for further observation.Post operative period will be defined from the closure of wound till 24 hours.
In the post-operative period, incidence of nausea, vomiting will be assessed by direct questioning the patient at 0.5, 1, 2, 6, 12, 24 hours after surgery.Severity of nausea will be assessed using a 11 point verbal rating scale(VRS), with 0 representing no nausea at all and 10 the worst nausea imaginable and “significant nausea†will be defined as any score of 4 and over.
The incidence of PONV will be defined as the occurrence of nausea and vomiting in the 24 hour period after the end of the surgery and time of the incidence of PONV from the administration of amisulpride will be noted.If it occurs, then rescue antiemetic ondansetron 4 mg intravenous will be given and total frequency of rescue anti-emetic doses given in the 24 hour postoperative period will be observed with time.
Type of rescue analgesic given in the first 24 hours will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients scheduled for surgery under general anaesthesia 2.Patients who are able to provide informed and written consent.
- •3.Patients with ASA status I,II,III.
排除标准
- •1.Refusal to give written and informed consent.
- •2.Haemodynamically unstable (patients in shock or on vasopressor support).
- •3.Patients expected to require post-operative ventilation or need a nasogastric tube or oro-gastric tube in situ after surgery.
- •4.Patients with Parkinson disease or a preexisting vestibular disorder or history of dizziness, a history of alcohol abuse, a clinical significant cardiac arrhythmia or epilepsy.
- •5.History of drug allergy/allergy to study drugs.
- •6.On steroid therapy, opioid therapy or medications causing nausea/vomiting 7.Pregnant and lactating patients.
- •8.Patients who received antiemetic drugs within 24 h before anesthesia.
- •9.Patients with congenital long QT syndrome.
结局指标
主要结局
To observe the incidence of post operative nausea and vomiting in patients undergoing elective or emergency surgery under general anaesthesia
时间窗: Post operative period 0-24 hours
次要结局
- 1.To assess Time of incidence of post operative nausea and vomiting from the administration of amisulpride.(2.To assess Frequency of rescue antiemetic(ondansetron) given after the occurrence of PONV in the 24 hours period postoperatively)
研究者
Dr Birva Khara
Pramukhswami Medical College,Shree Krishna Hospital, Bhaikaka University