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

NCT04962776 | Recruiting Phase 4

• 1 other identifier: IRB 6379/2021/FMASU MD261/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Length of Hospital Stay

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Low-concentration carbohydrate and nitrates group (CHON group )

ACTIVE COMPARATOR

Drug: Low-concentration carbohydrate and nitrates

Low-concentration carbohydrate group (CHO group)

ACTIVE COMPARATOR

Drug: Low-concentration carbohydrate

W group

PLACEBO COMPARATOR

Other: Water with placebo capsules

Interventions

Low-concentration carbohydrate and nitrates DRUG

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.

Low-concentration carbohydrate and nitrates group (CHON group )

Low-concentration carbohydrate DRUG

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.

Low-concentration carbohydrate group (CHO group)

Water with placebo capsules OTHER

Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.

W group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Nitrates; Water

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals; Hydroxides; Alkalies; Oxides; Oxygen Compounds

Central Study Contacts

Ibrahim Mamdouh Esmat

CONTACT

01001241928; ibrahim_mamdouh@med.asu.edu.eg

Tarek Mohamed Ashoor

CONTACT

tarekashoor@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 15, 2021
• Study Start: August 1, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)