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

Phase 4

Recruiting

• Conditions: Length of Hospital Stay
• Interventions: Drug: Low-concentration carbohydrate; Other: Water with placebo capsules; Drug: Low-concentration carbohydrate and nitrates

• Registration Number: NCT04962776
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-15
• Study Start: 2021-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-23
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Patients ageing from 18 to 60 years,
• American Society of Anesthesiologists (ASA) physical status I,II
• scheduled for elective open gynecological surgeries

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-concentration carbohydrate group (CHO group)	Low-concentration carbohydrate	-
W group	Water with placebo capsules	-
Low-concentration carbohydrate and nitrates group (CHON group )	Low-concentration carbohydrate and nitrates	-

Primary Outcome Measures

Name	Time	Method
The length of hospital stay (Days)	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)

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt