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Recruiting Phase 4 NCT04962776

NCT04962776 Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

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Clinical Trial Summary
NCT ID NCT04962776
Status Recruiting
Phase Phase 4
Sponsor Ain Shams University
Condition Length of Hospital Stay
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2021-08-01
Primary Completion 2026-04-30

Trial Parameters

Condition Length of Hospital Stay
Sponsor Ain Shams University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 90
Sex FEMALE
Min Age 18 Years
Max Age 60 Years
Start Date 2021-08-01
Completion 2026-04-30
Interventions
Low-concentration carbohydrate and nitratesLow-concentration carbohydrateWater with placebo capsules

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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.

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)

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