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Clinical Trials/NCT04962776
NCT04962776RecruitingPhase 4

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

Ain Shams University1 site in 1 country90 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
The length of hospital stay (Days)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts 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)

Arms & Interventions

Low-concentration carbohydrate and nitrates group (CHON group )

Active Comparator

Intervention: Low-concentration carbohydrate and nitrates (Drug)

Low-concentration carbohydrate group (CHO group)

Active Comparator

Intervention: Low-concentration carbohydrate (Drug)

W group

Placebo Comparator

Intervention: Water with placebo capsules (Other)

Outcomes

Primary Outcomes

The length of hospital stay (Days)

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Ain Shams University

Study Sites (1)

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