NCT04962776 Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
| NCT ID | NCT04962776 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ain Shams University |
| Condition | Length of Hospital Stay |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2021-08-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04962776 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Length of Hospital Stay. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04962776 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04962776 currently recruiting?
Yes, NCT04962776 is actively recruiting participants. Contact the research team at ibrahim_mamdouh@med.asu.edu.eg for enrollment information.
Where is the NCT04962776 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT04962776 clinical trial?
NCT04962776 is sponsored by Ain Shams University. The trial plans to enroll 90 participants.