Postoperative PainPhase 4NCT07852039
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
A Phase 4 study testing Caudal Dexmedetomidine and Intravenous Dexmedetomidine in people with Postoperative Pain and Caudal Anesthesia, run by Assiut University.
Trial summary
Caudal anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain, Caudal Anesthesia, Peripheral Perfusion
- What is being tested?
- Caudal Dexmedetomidine and Intravenous Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1 to 7 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective infraumbilical surgery.
- Anticipated duration of surgery less than 120 minutes.
- Written informed consent obtained from parents or legal guardians.
Who cannot join
- Coagulopathy or bleeding disorders.
- Pre-existing local infection at the caudal injection site.
- Known congenital heart disease.
- Neurological or neuromuscular disorders.
- Known allergy or hypersensitivity to dexmedetomidine, local anesthetics, or any study medication.
- Significant developmental delay affecting pain assessment.
- Failed caudal block.
- Parental or guardian refusal to participate.
About this study
Official title: Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery: A Randomized Double-Blind Controlled Study
Caudal anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. It can be given directly into the caudal space or through an intravenous (IV) line into the bloodstream, but it remains unclear which route provides better blood flow regulation and vital sign stability.
This study aims to compare the effects of caudal versus intravenous dexmedetomidine on peripheral blood flow, measured non-invasively using the Perfusion Index (PI), as well as heart rate and blood pressure in pediatric patients.
Read more
A total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups:
- Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion.
- Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine.
Neither the parents nor the healthcare team will know which study drug regimen the child receives. Investigators will record changes in the Perfusion Index, monitor heart rate and blood pressure throughout surgery and recovery, and evaluate postoperative pain scores and recovery room discharge times.
- Being tested
- Caudal Dexmedetomidine, Intravenous Dexmedetomidine
- Keywords
- Dexmedetomidine, Perfusion Index, Caudal Block, Levobupivacaine, Hemodynamics, Infraumbilical Surgery, Pediatric Anesthesia, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal DexmedetomidineDrug
Dexmedetomidine (1 µg/kg) combined with 0.25% levobupivacaine (total volume 1 mL/kg) administered into the caudal epidural space over 60 seconds under general anesthesia, along with a concurrent 10-minute IV placebo infusion of 20 mL normal saline.
Intravenous DexmedetomidineDrug
Dexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered as an intravenous infusion over 10 minutes, along with a concurrent caudal injection of 0.25% levobupivacaine (1 mL/kg) administered over 60 seconds under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group C: Caudal Dexmedetomidine | Active comparator | Participants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) combined with dexmedetomidine (1 µg/kg) injected over 60 seconds, accompanied by a simultaneous intravenous placebo infusion of 20 mL normal saline administered over 10 minutes. Receives: Drug: Caudal Dexmedetomidine |
| Group I: Intravenous Dexmedetomidine | Experimental | Participants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) alone injected over 60 seconds, accompanied by a simultaneous intravenous infusion of dexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered over 10 minutes. Receives: Drug: Intravenous Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Increase in Perfusion Index
Perfusion index (PI) is monitored continuously using a pulse oximeter probe placed on the middle finger of the right hand. PI reflects the ratio of pulsatile to non-pulsatile infrared light absorption (AC/DC x 100). Baseline PI is calculated as the mean of three consecutive stable readings obtained prior to caudal block placement. The primary outcome is the maximum increase in PI from baseline (peak PI minus baseline PI) observed during surgery and the recovery stay.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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, Mohamed Gamal El-Deen Mohamed Sallam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852039
- Sponsor's protocol ID
- IV vs Caudal Dexmedetomidine
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery: A Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07852039
- Acronym / sponsor ID
- IV vs Caudal Dexmedetomidine
- Keywords
- Dexmedetomidine, Perfusion Index, Caudal Block, Levobupivacaine, Hemodynamics, Infraumbilical Surgery, Pediatric Anesthesia, Postoperative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2026 (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 anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. It can be given directly into the caudal space or through an intravenous (IV) line into the bloodstream, but it remains unclear which route provides better blood flow regulation and vital sign stability.
This study aims to compare the effects of caudal versus intravenous dexmedetomidine on peripheral blood flow, measured non-invasively using the Perfusion Index (PI), as well as heart rate and blood pressure in pediatric patients.
A total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups:
- Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion.
- Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine.
Neither the parents nor the healthcare team will know which study drug regimen the child receives. Investigators will record changes in the Perfusion Index, monitor heart rate and blood pressure throughout surgery and recovery, and evaluate postoperative pain scores and recovery room discharge times.
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 C: Caudal Dexmedetomidine | Active comparator | Drug: Caudal DexmedetomidineParticipants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) combined with dexmedetomidine (1 µg/kg) injected over 60 seconds, accompanied by a simultaneous intravenous placebo infusion of 20 mL normal saline administered over 10 minutes. |
| Group I: Intravenous Dexmedetomidine | Experimental | Drug: Intravenous DexmedetomidineParticipants receive a caudal block containing 0.25% levobupivacaine (1 mL/kg) alone injected over 60 seconds, accompanied by a simultaneous intravenous infusion of dexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered over 10 minutes. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients aged 1 to 7 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective infraumbilical surgery.
- Anticipated duration of surgery less than 120 minutes.
- Written informed consent obtained from parents or legal guardians.
Key exclusion criteria (8 listed)
- Coagulopathy or bleeding disorders.
- Pre-existing local infection at the caudal injection site.
- Known congenital heart disease.
- Neurological or neuromuscular disorders.
- Known allergy or hypersensitivity to dexmedetomidine, local anesthetics, or any study medication.
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 |
|---|---|---|
| Caudal DexmedetomidineDexmedetomidine (1 µg/kg) combined with 0.25% levobupivacaine (total volume 1 mL/kg) administered into the caudal epidural space over 60 seconds under general anesthesia, along with a concurrent 10-minute IV placebo infusion of 20 mL normal saline. | Drug | Group C: Caudal Dexmedetomidine |
| Intravenous DexmedetomidineDexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered as an intravenous infusion over 10 minutes, along with a concurrent caudal injection of 0.25% levobupivacaine (1 mL/kg) administered over 60 seconds under general anesthesia. | Drug | Group I: Intravenous Dexmedetomidine |
Primary outcome
Peak Increase in Perfusion Index
Time frame: Up to 4 hours
Perfusion index (PI) is monitored continuously using a pulse oximeter probe placed on the middle finger of the right hand. PI reflects the ratio of pulsatile to non-pulsatile infrared light absorption (AC/DC x 100). Baseline PI is calculated as the mean of three consecutive stable readings obtained prior to caudal block placement. The primary outcome is the maximum increase in PI from baseline (peak PI minus baseline PI) observed during surgery and the recovery stay.
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 1 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caudal Dexmedetomidine and Intravenous Dexmedetomidine in people with Postoperative Pain and 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 5 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 1 Oct 2026. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Increase in Perfusion Index (time frame: Up to 4 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 1 Oct 2026.