Clinical trial NCT03757208: Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy
Official title: Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Care
Keywords: Carbohydrate loading, oral carbohydrate beverage
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Seinajoki Central Hospital
First posted: 2018-11-28
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of given pain and antiemetic medication (n)
timeFrame: One day (in recovery room after operation to discharge time)
measure: Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)
timeFrame: One day (4 hours after operation and at discharge)
measure: Time of drinking, eating and first mobilisation (minutes after operation)
timeFrame: One day (in recovery room after operation to discharge time)
measure: Time of discharge (hours after operation)
timeFrame: One day (time of discharge)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Oulu
name: Kari Haukipuro, Ph.M.D
role: STUDY_CHAIR
References:
citation: 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.