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临床试验/NCT06319144
NCT06319144已完成不适用

Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

Weifang Medical University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Preoperative blood glucose 30min

研究概览

简要总结

The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
  • The patient or his/her guardian or immediate family members gave informed consent;
  • American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.

排除标准

  • Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
  • Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
  • Intravenous nutritional support within 8 hours prior to the examination;
  • Patients diagnosed with type I or type II diabetes.

研究组 & 干预措施

Experimental group

Active Comparator

Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator.

干预措施: 5% glucose (Other)

结局指标

主要结局

Preoperative blood glucose 30min

时间窗: Measurements taken 0.5 hours Preoperative.

A fingertip blood glucose concentration of \<3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 0.5 hours Preoperative.

Postoperative blood glucose 2h

时间窗: Measured at 2 hours postoperatively.

A fingertip blood glucose concentration of \<3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 2 hours postoperatively.

Dizziness level

时间窗: Measured at 0.5 hours postoperatively.

The visual analogue scale (VAS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.

Postoperative nausea and vomiting

时间窗: Measured at 2 hours postoperatively.

The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.

次要结局

  • Anesthesia awakening time(Approximately 30min after surgery)
  • Quality of postoperative recovery (QoR40)(Approximately 24hours after surgery)

研究者

发起方
Weifang Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Cheng

Research investigator

Weifang Medical University

研究点 (1)

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