drugset / Trial / NCT04962776

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

NCT04962776

Phase 4 Recruiting 90 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2021-08-01
Primary completion
2026-04-30
Completion
2026-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator beet root extract Unknown 1 g Oral
Comparator Low-concentration carbohydrate Unknown Oral
Comparator maltodextrin Unknown Oral

Indications

No indication recorded.