The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 主要终点
- frequency of post-opertive nausea and vomiting in 24 hour
研究概览
简要总结
This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures
详细描述
A history of PONV risk factors will be recorded. After consenting, patients will be assigned using a computerized randomization function to Ringer solution (group R) or 5% dextrose (group D) or control group (group C). Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia. Group R will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia. Group C will receive no fluids. The anesthesia providers, surgeons, perioperative nurses, postanesthesia care unit (PACU) nurses and investigators will be blinded to group assignment throughout.
As for pre-medication, all patients will receive IV midazolam (0.02 mg/kg). Anesthesia will be induced with propofol (1.5-2 mg/kg), fentanyl (1-2 μg/kg) and atracurium(o.5mg/kg) to facilitate endotracheal intubation. The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2/air. Intraoperative IV maintenance fluid will be standardized at 3 mL/kg/h with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased >20% from baseline. For postoperative pain relief, paracetamol 1 g will be given I.V. during surgery in all patients and continued orally after operation (1g every 6 h). In addition, all patients will be ambulated within 6 h after completion of surgery. Standardized antiemetic and analgesic rescue medications will be available. Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2; 1 dose of rescue medication when the VRS score is 3 to 6; and ≥2 doses for nausea score of 7 to 10, to reduce the nausea score to 0 to 2.
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion
- •ASA physical status I and ll.
排除标准
- •patients with a previous history of PONV.
- •Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension
- •patients with cardiac, renal or hepatic dysfunction.
- •patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery
- •patients who have abnormal blood glucose on the night before surgery
- •patients who are unable to understand and use the verbal rating scale (VRS);Growth developmental, and motor-mental retardation.
研究组 & 干预措施
group c
control group . this group will not receive any iv fluids
结局指标
主要结局
frequency of post-opertive nausea and vomiting in 24 hour
时间窗: FROM ENROLLMENT TO 24 HOURS AFTER SURGERY
using verbal rating scale (VRS)
次要结局
- TOTAL AMOUNT OF ANTIEMETIC REQUIRED(From end of surgery to 24 hours postoperative)
研究者
Yasmin Hassab elnaby
assistant professor
Cairo University
