Skip to main content
Clinical Trials/NCT04962776
NCT04962776
Recruiting
Phase 4

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

Ain Shams University1 site in 1 country90 target enrollmentAugust 1, 2021

Overview

Phase
Phase 4
Intervention
Low-concentration carbohydrate and nitrates
Conditions
Length of Hospital Stay
Sponsor
Ain Shams University
Enrollment
90
Locations
1
Primary Endpoint
The length of hospital stay (Days)
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
April 30, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Mamdouh Esmat

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

Ain Shams University

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)

Arms & Interventions

Low-concentration carbohydrate and nitrates group (CHON group )

Intervention: Low-concentration carbohydrate and nitrates

Low-concentration carbohydrate group (CHO group)

Intervention: Low-concentration carbohydrate

W group

Intervention: Water with placebo capsules

Outcomes

Primary Outcomes

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.

The length of hospital stay (Days)

Study Sites (1)

Loading locations...

Similar Trials