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
Overview
- Phase
- Phase 4
- Intervention
- Low-concentration carbohydrate and nitrates
- Conditions
- Length of Hospital Stay
- Sponsor
- Ain Shams University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- The length of hospital stay (Days)
- Status
- Recruiting
- Last Updated
- 5 months ago
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.
Investigators
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University
Eligibility Criteria
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 )
Intervention: Low-concentration carbohydrate and nitrates
Low-concentration carbohydrate group (CHO group)
Intervention: Low-concentration carbohydrate
W group
Intervention: Water with placebo capsules
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)