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

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Length of Hospital Stay

Treatments: Other: Water with placebo capsules; Drug: Low-concentration carbohydrate; Drug: Low-concentration carbohydrate and nitrates

Study type: Interventional

Funder types: Other

Identifiers

NCT04962776

IRB 6379/2021/FMASU MD261/2025

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Low-concentration carbohydrate and nitrates group (CHON group )

Active Comparator group

Treatment:

Drug: Low-concentration carbohydrate and nitrates

Low-concentration carbohydrate group (CHO group)

Active Comparator group

Treatment:

Drug: Low-concentration carbohydrate

W group

Placebo Comparator group

Treatment:

Other: Water with placebo capsules