Combining low-concentration carbohydrates with nitrates before gynecological surgery
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
This study is testing if drinking a mix of low-concentration carbohydrates and nitrates before gynecological surgery can help patients recover better and stay in the hospital for a shorter time.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT04962776 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of preoperative coadministration of low-concentration carbohydrates and nitrates compared to low-concentration carbohydrates alone in patients undergoing open gynecological surgeries. The aim is to reduce the stress response associated with surgery, which can negatively impact recovery and length of hospital stay. By utilizing nitrate-rich drinks, the study seeks to improve blood flow and metabolic efficiency, potentially enhancing patient outcomes. The trial will involve patients aged 18 to 60 with specific health criteria to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 60 scheduled for elective open gynecological surgeries with ASA physical status I or II.
Not a fit: Patients with diabetes, previous chemotherapy, or certain medication use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and improved recovery for patients undergoing gynecological surgeries.
How similar studies have performed: While the specific combination of treatments is novel, similar approaches using carbohydrate loading have shown promise in enhancing recovery in surgical patients.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cairo
- Ain-Shams University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ibrahim Mamdouh Esmat
- Email: ibrahim_mamdouh@med.asu.edu.eg
- Phone: 01001241928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.