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

NCT ID: NCT04962776

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Low-concentration carbohydrate and nitrates group (CHON group )

Group Type: ACTIVE_COMPARATOR

Low-concentration carbohydrate and nitrates

Intervention Type: 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 group (CHO group)

Group Type: ACTIVE_COMPARATOR

Low-concentration carbohydrate

Intervention Type: 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.

W group

Group Type: PLACEBO_COMPARATOR

Water with placebo capsules

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain-Shams University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ibrahim Mamdouh Esmat

Role: CONTACT

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Tarek Mohamed Ashoor

Role: CONTACT

tarekashoor@med.asu.edu.eg

Facility Contacts

Ibrahim Mamdouh Esmat

Role: primary

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Other Identifiers

IRB 6379/2021/FMASU MD261/2025

Identifier Type: -

Identifier Source: org_study_id