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

Length of Hospital Stay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962776
• Other study ID #: IRB 00006379//10-7-2021
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Ain Shams University
• Contact: Ibrahim Mamdouh Esmat
• Phone: 01001241928
• Email: ibrahim_mamdouh[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Length of Hospital Stay

Intervention

Drug:
• Low-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.
• Low-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.

Other:
• Water 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

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of hospital stay (Days)	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.