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临床试验/NCT06288542
NCT06288542Unknown不适用

The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries: A Randomized Control Trial

Cairo University0 个研究点目标入组 111 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
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

No Intervention

control group . this group will not receive any iv fluids

group r

Active Comparator

this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia

干预措施: group R (Other)

group d

Experimental

Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia

干预措施: group d (Other)

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

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

Yasmin Hassab elnaby

assistant professor

Cairo University

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