Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

A Randomised Controlled Study of Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

Surgery is known to be associated with stress response affecting in a negative way the clinical outcome and patient experience. The stress response includes both sympathetic nervous system activation and systemic inflammatory response. The pituitary- sympathetic one leads to a number of metabolic changes as hyperglycemia, nitrogen loss and lipolysis on the other hand the systemic inflammatory response aggravates the perioperative metabolic changes. One of components of ERAS is preoperative carbohydrate load. Oral carbohydrate was associated with attenuation of the postoperative metabolic stress response. Nitrate rich drinks before exercises have a promising impact due to improving blood flow, mitochondrial efficiency, glucose uptake and the sarcoplasmic calcium handling all of which maximize resistance to fatigue and improved exercise performance.

Study Overview

• Status: Recruiting
• Conditions: Length of Hospital Stay
• Intervention / Treatment: Drug: Low-concentration carbohydrate and nitrates; Drug: Low-concentration carbohydrate; Other: Water with placebo capsules

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ibrahim Mamdouh Esmat; Phone Number: 01001241928; Email: ibrahim_mamdouh@med.asu.edu.eg
• Study Contact Backup: Name: Tarek Mohamed Ashoor; Email: tarekashoor@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain-Shams University Hospitals
    • Contact: Ibrahim Mamdouh Esmat; Phone Number: 01001241928; Email: ibrahim_mamdouh@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ageing from 18 to 60 years,
• American Society of Anesthesiologists (ASA) physical status I,II
• scheduled for elective open gynecological surgeries

Exclusion Criteria:

Patients with

• Previous chemotherapy treatment,
• Disseminated malignant disease,
• BMI more than 40,
• Known allergy to one or more of the study medications
• Refusal to participate in the study
• Patients diagnosed with diabetes milieus either type I or type II,
• Patients with previous bariatric surgeries
• Patients under medications that delay gastric emptying (tricyclic anti-depressants, chronic use of laxatives)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-concentration carbohydrate and nitrates group (CHON group )	Drug: Low-concentration carbohydrate and nitrates; Patients in the CHON group will be given 400 mL of a clear carbohydrate drink (12.5 g/100 mL maltodextrin, 50 kcal/100 mL) and 2 capsules of beet root extract 1 gm on the evening before surgery (8 hours) and another 200 mL of the carbohydrate drink and 1 capsule of beet root extract 1 gm on the day of surgery, 2 h before anesthesia induction.
Active Comparator: Low-concentration carbohydrate group (CHO group)	Drug: Low-concentration carbohydrate; Patients in the CHO group will be given the same carbohydrate drink in the CHON group with 2 placebo capsules with the evening drink and one with the morning drink.
Placebo Comparator: W group	Other: Water with placebo capsules; Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of hospital stay (Days)	The length of hospital stay (Days)	The study end point will be 7 days from the operation or when patient will be discharged from hospital which of which will be earlier.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB 00006379//10-7-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No