Caudal AnesthesiaPhase 4NCT06747975
Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia on Hypospadias Surgery
A Phase 4 study testing Dexamethasone and Ondansetron and Bupivacaine + saline in people with Caudal Anesthesia, run by Assiut University.
Trial summary
caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Caudal Anesthesia
- What is being tested?
- Dexamethasone and Ondansetron and Bupivacaine + saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 2 to 12 years old.
- Patients with stable vital signs.
- Patients with normal laboratory investigations.
- Patients undergoing Caudal anaesthesia for infraumbilical surgeries
Who cannot join
- Patient's parental refusal.
- Age < 2 or > 12 years.
- Contraindications to Caudal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection ,pilonidal cyst and congenital anomalies of lower spine because of unclear or impalpable anatomy
- Patients with cardiac morbidities.
- Failure of caudal block
- Diabetes mellitus
- Convulsions.
- Known allergy to any drugs used in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia
caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general anesthesia, accelerates the awakening, suppresses the surgical neurohumoral stress response and can be performed easily The objective of the current study is to determine the efficacy and safety of prophylactic intravenous administration of combination of 0.1mg/kg of dexamethasone plus 4mg of ondansetron immediately before establishment of caudal block for prevention of Nausea\&vomiting and Shivering in pediatric patients undergoing infra umbilical surgeries
Read the detailed description
Although it has some adverse effects: postoperative nausea and vomiting (PONV) are frequent and morbidity-related complication in children, PONV is still present in almost twice the frequency of adults, 33.2-82%. shivering is one of frequent, undesirable adverse effects, The incidence of shivering is up to 40-60% even in regional anaesthesia leads to O2 consumption and CO2 production,So we target in this study two effective drugs with less side effects to reduse these adverse effects Ondansetron is a highly potent selective 5 hydroxytryptamine receptor antagonist, which is widely used as an anti-emetic, Its mechanism of action as anti-shivering is not clear and it is proposed to act centrally at the level of the pre-optic anterior hypothalamic region by inhibition of serotonin reuptake Dexamethasone: is a potent class of steroid drugs ,It prevents thermoregulatory shivering via its central inhibitory effect on the thermoregulatory center and prevents non thermoregulatory shivering by its anti-inflammatory activity, i.e. antagonizing the activation of the inflammatory responses and release of cytokines during surgery The anti-emetic properties of dexamethasone are well established but the mechanisms underlying this anti-emetic effect remain largely unknown
- Conditions
- Caudal Anesthesia
- Being tested
- Dexamethasone and Ondansetron, Bupivacaine + saline
- Keywords
- dexamethasone, ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone and OndansetronDrug
patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline
Bupivacaine + salineDrug
patients will receive caudal epidural block (0.5 mL/kg of bupivacaine 0.25% only) and IV 5 mL normal saline
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | fifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline Receives: Drug: Dexamethasone and Ondansetron; Drug: Bupivacaine + saline |
| group B | Placebo comparator | fifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline Receives: Drug: Bupivacaine + saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of all emesis
the incidence of all emesis in the 24 h after surgery (PONV).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Fathy Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747975
- Sponsor's protocol ID
- dexamethasone+ondansetron PONV
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia
- ClinicalTrials.gov ID
- NCT06747975
- Acronym / sponsor ID
- dexamethasone+ondansetron PONV
- Conditions
- Caudal Anesthesia
- Keywords
- dexamethasone, ondansetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Dec 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.
caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general anesthesia, accelerates the awakening, suppresses the surgical neurohumoral stress response and can be performed easily The objective of the current study is to determine the efficacy and safety of prophylactic intravenous administration of combination of 0.1mg/kg of dexamethasone plus 4mg of ondansetron immediately before establishment of caudal block for prevention of Nausea\&vomiting and Shivering in pediatric patients undergoing infra umbilical surgeries
Detailed description
Although it has some adverse effects: postoperative nausea and vomiting (PONV) are frequent and morbidity-related complication in children, PONV is still present in almost twice the frequency of adults, 33.2-82%. shivering is one of frequent, undesirable adverse effects, The incidence of shivering is up to 40-60% even in regional anaesthesia leads to O2 consumption and CO2 production,So we target in this study two effective drugs with less side effects to reduse these adverse effects Ondansetron is a highly potent selective 5 hydroxytryptamine receptor antagonist, which is widely used as an anti-emetic, Its mechanism of action as anti-shivering is not clear and it is proposed to act centrally at the level of the pre-optic anterior hypothalamic region by inhibition of serotonin reuptake Dexamethasone: is a potent class of steroid drugs ,It prevents thermoregulatory shivering via its central inhibitory effect on the thermoregulatory center and prevents non thermoregulatory shivering by its anti-inflammatory activity, i.e. antagonizing the activation of the inflammatory responses and release of cytokines during surgery The anti-emetic properties of dexamethasone are well established but the mechanisms underlying this anti-emetic effect remain largely unknown
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Dexamethasone and Ondansetron, Drug: Bupivacaine + salinefifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline |
| group B | Placebo comparator | Drug: Bupivacaine + salinefifty patients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 2 to 12 years old.
- Patients with stable vital signs.
- Patients with normal laboratory investigations.
- Patients undergoing Caudal anaesthesia for infraumbilical surgeries
Key exclusion criteria (8 listed)
- Patient's parental refusal.
- Age < 2 or > 12 years.
- Contraindications to Caudal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection ,pilonidal cyst and congenital anomalies of lower spine because of unclear or impalpable anatomy
- Patients with cardiac morbidities.
- Failure of caudal block
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 |
|---|---|---|
| Dexamethasone and Ondansetronpatients will receive Caudal epidural block (0.5 mL/kg of bupivacaine 0.25% plus dexa- methasone 0.1 mg/kg plus 4mg ondansetron ), and IV 5 mL normal saline | Drug | group A |
| Bupivacaine + salinepatients will receive caudal epidural block (0.5 mL/kg of bupivacaine 0.25% only) and IV 5 mL normal saline | Drug | group A, group B |
Primary outcome
the incidence of all emesis
Time frame: 24 hours
the incidence of all emesis in the 24 h after surgery (PONV).
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 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Ondansetron and Bupivacaine + saline in people with Caudal Anesthesia, run by Assiut 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: opening soon, as of the sponsor's last update on 24 Dec 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.
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 Abdelrahman Fathy Ahmed Mahny, resident doctor (+20 10 05086251, dr.3bdo202020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of all emesis (time frame: 24 hours). 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 Dec 2024.