RecruitingPhase 4NCT04962776

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


Sponsor

Ain Shams University

Enrollment

90 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • 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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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.


Locations(1)

Ain-Shams University Hospitals

Cairo, Egypt

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NCT04962776


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