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Recruiting NCT04962776

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

Phase IV Interventional Length of Hospital Stay

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-concentration carbohydrate and nitrates, Low-concentration carbohydrate, Water with placebo capsules.
Who it may be relevant to
Registry conditions: Length of Hospital Stay. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • The length of hospital stay (Days) [Time frame: 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.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain-Shams University Hospitals — Cairo

Identifiers

NCT: NCT04962776 · IRB 6379/2021/FMASU MD261/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗