Postoperative Nausea and VomitingNCT06376929
Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level
A study testing oral carbohydrate containing fluid in people with Postoperative Nausea and Vomiting, run by Cairo University.
Trial summary
The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- oral carbohydrate containing fluid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females
- 3 years to 9 years
- Undergoing ophthalmic surgeries
- ASA I -II
Who cannot join
- • Parent refusal
- Age <3 or >9
- Underlying proemetic disease
- Positive history of Postoperative nausea and vomiting in patient, parent or sibling
- Currently on antiemetic medications
- History of juvenile diabetes
- Lengthy operations more than 3 hours
- intraoperative Blood transfusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Preoperative Low Dose Oral Carbohydrates Fluid Intake on Intraoperative Random Blood Glucose and Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Ophthalmic Surgeries
The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting.
Read the detailed description
Surgeries are considered one of the most common causes of stress response in our bodies. Common stressors include prolonged fasting, anxiety, massive tissue injury, and release of inflammatory mediators.
Hospital stay and wound healing are considered common areas of postoperative distress.
Paediatric patients undergoing surgery are subjected to stress as they are removed from their ordinary daily routine and are exposed to a number of preoperative procedures that cause anxiety and discomfort.
One major cause of discomfort and stress is the need for preoperative fasting, which is needed and accepted all over the world as a standard precaution to minimise the risk of aspiration and regurgitation during induction of general anaesthesia. Based mainly on recommendations issued by anaesthesia societies worldwide, the standard guidelines for preoperative fasting in paediatric surgery is 6 hours for solid food , 6 hours for formula milk or cow milk, 4 hours for breast milk, and 2 h for clear fluids including clear juice and water.
This strategy of preoperative fasting is a significant contributor to postoperative nausea and vomiting, other reactions such as postoperative pain , inflammatory response to surgery, and perioperative insulin resistance which is thought to affect the random blood sugar RBS. Moreover, surgical stress response causes elevation of anti insulin hormones and reduces insulin secretion which can be detrimental for surgical patients in many aspects including recovery, wound healing, and duration of hospital stay. Criticisms of standard preoperative fasting have forced practitioners to explore new ways of preparing patients for theatre. Studies previously conducted in adults exposed to cholecystectomy showed that administration of a carbohydrate beverage diminishes insulin resistance and the organs' response to trauma.
In our study we aim to address the difference between preoperative intake of oral carbohydrates and clear water on intraoperative RBS and postoperative nausea and vomiting. We thought to limit the type of surgeries to ophthalmic surgeries in an attempt to limit the discrepancy in PONV risk in different types of surgeries, higher risk of PONV and low risk of dropouts as not liable to be lengthy operations and lower risk of blood transfusion
It is thought that preoperative carbohydrate fluid intake will decrease the insulin resistance intraoperative, thus will affect the intraoperative level of random blood glucose, and post operative nausea and vomiting. This based on the idea that Preoperative fasting leads to mobilisation of lipids, increased catabolism of muscle protein, which results in ketone bodies elevation.The resulting increase in insulin resistance requires eight times the normal amount of insulin volume to maintain postoperative blood glucose at normal levels. Intraoperative catabolism is also affected by the invasiveness of the surgery, the type of anaesthesia, blood loss and body temperature, although no studies have evaluated lipid and protein catabolism but random blood glucose levels can be assessed easily and rapidly.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- oral carbohydrate containing fluid
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral carbohydrate containing fluidOther
administration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting
| Study group | Role | What they receive |
|---|---|---|
| oral carbohydrate group | Active comparator | Not described Receives: Other: oral carbohydrate containing fluid |
| control group | Placebo comparator | Not described Receives: Other: oral carbohydrate containing fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean values of Intraoperative random blood sugar in mg/dl
Mean values of Intraoperative random blood sugar in mg/dl
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd El Moneim Soaida, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376929
- Sponsor's protocol ID
- oralcarbohydrateinpediatric
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Low Dose Oral Carbohydrates Fluid Intake on Intraoperative Random Blood Glucose and Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Ophthalmic Surgeries
- ClinicalTrials.gov ID
- NCT06376929
- Acronym / sponsor ID
- oralcarbohydrateinpediatric
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting.
Detailed description
Surgeries are considered one of the most common causes of stress response in our bodies. Common stressors include prolonged fasting, anxiety, massive tissue injury, and release of inflammatory mediators.
Hospital stay and wound healing are considered common areas of postoperative distress.
Paediatric patients undergoing surgery are subjected to stress as they are removed from their ordinary daily routine and are exposed to a number of preoperative procedures that cause anxiety and discomfort.
One major cause of discomfort and stress is the need for preoperative fasting, which is needed and accepted all over the world as a standard precaution to minimise the risk of aspiration and regurgitation during induction of general anaesthesia. Based mainly on recommendations issued by anaesthesia societies worldwide, the standard guidelines for preoperative fasting in paediatric surgery is 6 hours for solid food , 6 hours for formula milk or cow milk, 4 hours for breast milk, and 2 h for clear fluids including clear juice and water.
This strategy of preoperative fasting is a significant contributor to postoperative nausea and vomiting, other reactions such as postoperative pain , inflammatory response to surgery, and perioperative insulin resistance which is thought to affect the random blood sugar RBS. Moreover, surgical stress response causes elevation of anti insulin hormones and reduces insulin secretion which can be detrimental for surgical patients in many aspects including recovery, wound healing, and duration of hospital stay. Criticisms of standard preoperative fasting have forced practitioners to explore new ways of preparing patients for theatre. Studies previously conducted in adults exposed to cholecystectomy showed that administration of a carbohydrate beverage diminishes insulin resistance and the organs' response to trauma.
In our study we aim to address the difference between preoperative intake of oral carbohydrates and clear water on intraoperative RBS and postoperative nausea and vomiting. We thought to limit the type of surgeries to ophthalmic surgeries in an attempt to limit the discrepancy in PONV risk in different types of surgeries, higher risk of PONV and low risk of dropouts as not liable to be lengthy operations and lower risk of blood transfusion
It is thought that preoperative carbohydrate fluid intake will decrease the insulin resistance intraoperative, thus will affect the intraoperative level of random blood glucose, and post operative nausea and vomiting. This based on the idea that Preoperative fasting leads to mobilisation of lipids, increased catabolism of muscle protein, which results in ketone bodies elevation.The resulting increase in insulin resistance requires eight times the normal amount of insulin volume to maintain postoperative blood glucose at normal levels. Intraoperative catabolism is also affected by the invasiveness of the surgery, the type of anaesthesia, blood loss and body temperature, although no studies have evaluated lipid and protein catabolism but random blood glucose levels can be assessed easily and rapidly.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| oral carbohydrate group | Active comparator | Other: oral carbohydrate containing fluid |
| control group | Placebo comparator | Other: oral carbohydrate containing fluid |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females
- 3 years to 9 years
- Undergoing ophthalmic surgeries
- ASA I -II
Key exclusion criteria (8 listed)
- • Parent refusal
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 |
|---|---|---|
| oral carbohydrate containing fluidadministration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting | Other | control group, oral carbohydrate group |
Primary outcome
Mean values of Intraoperative random blood sugar in mg/dl
Time frame: 3 months
Mean values of Intraoperative random blood sugar in mg/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing oral carbohydrate containing fluid in people with Postoperative Nausea and Vomiting, run by Cairo University.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala El Sabbagh (01005207896, halaelsabbagh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean values of Intraoperative random blood sugar in mg/dl (time frame: 3 months). 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 25 Apr 2024.