Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
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
- Length of Hospital Stay
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Ain Shams University
- Enrolment target
- 90
- Started
- 1 August 2021
- Main results due
- 31 January 2027
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 60 years.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Ain-Shams University Hospitals
Cairo, Egypt
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04962776. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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