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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04962776
Enrollment
90
Registered
2021-07-15
Start date
2021-08-01
Completion date
2026-04-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Hospital Stay

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.

Interventions

DRUGLow-concentration carbohydrate and nitrates

Patients in the CHON group will be given 400 mL of a clear carbohydrate drink (12.5 g/100 mL maltodextrin, 50 kcal/100 mL) and 2 capsules of beet root extract 1 gm on the evening before surgery (8 hours) and another 200 mL of the carbohydrate drink and 1 capsule of beet root extract 1 gm on the day of surgery, 2 h before anesthesia induction.

DRUGLow-concentration carbohydrate

Patients in the CHO group will be given the same carbohydrate drink in the CHON group with 2 placebo capsules with the evening drink and one with the morning drink.

OTHERWater with placebo capsules

Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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)

Countries

Egypt

Contacts

Primary ContactIbrahim Mamdouh Esmat
ibrahim_mamdouh@med.asu.edu.eg01001241928
Backup ContactTarek Mohamed Ashoor
tarekashoor@med.asu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026