Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy

Preoperative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757208
• Other study ID #: Uoulu 192/2012
• Status: Completed
• Phase: N/A
• Start date: April 8, 2013
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 15, 2017
• Est. primary completion date: May 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Preoperative Care

Intervention

Dietary Supplement:
• carbohydrate rich drink
The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Seinajoki Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of given pain and antiemetic medication (n)		One day (in recovery room after operation to discharge time)
Primary	Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)		One day (4 hours after operation and at discharge)
Primary	Time of drinking, eating and first mobilisation (minutes after operation)		One day (in recovery room after operation to discharge time)
Primary	Time of discharge (hours after operation)		One day (time of discharge)