Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy

NCT03757208 | Completed

• 1 other identifier: Uoulu 192/2012
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Preoperative Care

Keywords

Carbohydrate loading, oral carbohydrate beverage

Outcome Measures

Primary Outcomes (4)

• Number of given pain and antiemetic medication (n)

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

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

  One day (4 hours after operation and at discharge)

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

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

• Time of discharge (hours after operation)

  One day (time of discharge)

Study Arms (2)

Fasting group

NO INTERVENTION

Carbohydrate rich drink (CHD) group

ACTIVE COMPARATOR

Dietary Supplement: carbohydrate rich drink

Interventions

carbohydrate rich drink DIETARY_SUPPLEMENT

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

Carbohydrate rich drink (CHD) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Seinajoki Central Hospital: collaborator

Related Publications (1)

• Helminen H, Branders H, Ohtonen P, Saarnio J. Effect of pre-operative oral carbohydrate loading on recovery after day-case cholecystectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):605-611. doi: 10.1097/EJA.0000000000001002.

  PMID: 31021880 DERIVED

Study Officials

• Kari Haukipuro, Ph.M.D

  University Hospital of Oulu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 28, 2018
• Study Start: April 8, 2013
• Primary Completion: May 16, 2016
• Study Completion: November 15, 2017
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share