Length of Hospital StayPhase 4NCT04962776
Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
A Phase 4 study testing Low-concentration carbohydrate and nitrates and Low-concentration carbohydrate in people with Length of Hospital Stay, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Length of Hospital Stay
- What is being tested?
- Low-concentration carbohydrate and nitrates and Low-concentration carbohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients ageing from 18 to 60 years,
- American Society of Anesthesiologists (ASA) physical status I,II
- scheduled for elective open gynecological surgeries
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tarek Mohamed Ashoor contact
Egypt1 site, 1 recruiting
- Recruiting
Ain-Shams University Hospitals
Cairo
Ibrahim Mamdouh Esmat, 01001241928, ibrahim_mamdouh@med.asu.edu.eg
About this study
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
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.
- Conditions
- Length of Hospital Stay
- Being tested
- Low-concentration carbohydrate and nitrates, Low-concentration carbohydrate, Water with placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-concentration carbohydrate and nitratesDrug
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 carbohydrateDrug
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.
Water with placebo capsulesOther
Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Low-concentration carbohydrate and nitrates group (CHON group ) | Active comparator | Not described Receives: Drug: Low-concentration carbohydrate and nitrates |
| Low-concentration carbohydrate group (CHO group) | Active comparator | Not described Receives: Drug: Low-concentration carbohydrate |
| W group | Placebo comparator | Not described Receives: Other: Water with placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospital stay (Days)
The length of hospital stay (Days)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Aug 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Length of Hospital StayStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962776
- Sponsor's protocol ID
- IRB 6379/2021/FMASU MD261/2025
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04962776
- Acronym / sponsor ID
- IRB 6379/2021/FMASU MD261/2025
- Conditions
- Length of Hospital Stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-concentration carbohydrate and nitrates group (CHON group ) | Active comparator | Drug: Low-concentration carbohydrate and nitrates |
| Low-concentration carbohydrate group (CHO group) | Active comparator | Drug: Low-concentration carbohydrate |
| W group | Placebo comparator | Other: Water with placebo capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients ageing from 18 to 60 years,
- American Society of Anesthesiologists (ASA) physical status I,II
- scheduled for elective open gynecological surgeries
Key exclusion criteria (9 listed)
- Patients with
- Previous chemotherapy treatment,
- Disseminated malignant disease,
- BMI more than 40,
- Known allergy to one or more of the study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-concentration carbohydrate and nitratesPatients 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. | Drug | Low-concentration carbohydrate and nitrates group (CHON group ) |
| Low-concentration carbohydratePatients 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. | Drug | Low-concentration carbohydrate group (CHO group) |
| Water with placebo capsulesPatients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery. | Other | W group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Length of Hospital Stay
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarek Mohamed Ashoor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-concentration carbohydrate and nitrates and Low-concentration carbohydrate in people with Length of Hospital Stay, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Mamdouh Esmat (01001241928, ibrahim_mamdouh@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.