Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery

NCT06243367 | Recruiting

• 1 other identifier: 35129/12/21
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.

Conditions

Carbohydrate; Fasting; Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• The metabolic response

  The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively.

  5 days postoperatively

Secondary Outcomes (4)

• The postoperative inflammatory response

  First day postoperative

• Complications

  24 hours postoperatively

• Time of independent ambulation

  27 days postoperatively

• Postoperative discharge day

  27 days postoperatively

Study Arms (2)

Fast (Control) group

PLACEBO COMPARATOR

Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery

Other: Placebo drink

Carbohydrate group

EXPERIMENTAL

Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Dietary Supplement: Carbohydrate

Interventions

Placebo drink OTHER

Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery

Fast (Control) group

Carbohydrate DIETARY_SUPPLEMENT

Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Carbohydrate group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 21 and 70 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status l \& ll.
• Scheduled for elective major abdominal surgery

You may not qualify if:

• Disseminated malignant disease.
• Increased risk for gastric content aspiration.
• Body Mass Index (BMI) below 20 or above 30 kg/m2.
• Nutritional risk screening 2002 score above 3.
• Emergency surgery, diabetic patients, immunomodulatory therapy.
• Refusal of the patient.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Fasting

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Eman M AboOmar, Master

CONTACT

00201090822808; emantaher6669@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 6, 2024
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)