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临床试验/NCT03757208
NCT03757208已完成不适用

Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.

University of Oulu0 个研究点目标入组 113 人开始时间: 2013年4月8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
入组人数
113
主要终点
Time of drinking, eating and first mobilisation (minutes after operation)

研究概览

简要总结

Background: Preoperative carbohydrate loading has been shown to reduce preoperative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have been focused on patients undergoing day-case surgery.

Objective: The aim of this prospective randomized study was to determine whether preoperative carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.

Design: A randomised controlled trial. Setting: Secondary care in a district general and a university hospital in Finland between 2013-2016.

Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation disorders, BMI >40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse.

Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery, and the control (Fasting) group fasted from midnight according to standard protocol.

Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first mobilization after surgery, and the time to discharge and hospital readmission were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-70 yr (ASA physical status I-II) eligible for day-case cholecystectomy

排除标准

  • Patients with bleeding or coagulation disorders, BMI >40, dementia or suffering from insulin-treated diabetes, migraine, Meniere's disease or with history of alcohol or drug abuse

研究组 & 干预措施

Fasting group

No Intervention

Carbohydrate rich drink (CHD) group

Active Comparator

干预措施: carbohydrate rich drink (Dietary Supplement)

结局指标

主要结局

Time of drinking, eating and first mobilisation (minutes after operation)

时间窗: One day (in recovery room after operation to discharge time)

Time of discharge (hours after operation)

时间窗: One day (time of discharge)

Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)

时间窗: One day (4 hours after operation and at discharge)

Number of given pain and antiemetic medication (n)

时间窗: One day (in recovery room after operation to discharge time)

次要结局

未报告次要终点

研究者

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

Heli Helminen

Principal Investigator

University of Oulu

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