Pain, PostoperativePhase 2/3JASayedNCT02487355
Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries
A Phase 2/3 study testing Dexmedetomidine, Magnesium Sulphate and Bupivacaine in people with Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexmedetomidine, Magnesium Sulphate and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Dec 2017
- Phase
- Phase 2/3
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block
Who cannot join
- Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Univeristy Hospital
Asyut, 715715
jehan A sayed, MD, +2 01006253939, jehan.alloul@yahoo.com
About this study
Official title: Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries
The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.
Read the detailed description
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- Conditions
- Pain, Postoperative
- Being tested
- Dexmedetomidine, Magnesium Sulphate, Bupivacaine, Dexmedetomidine + Magnesium Sulphate + Bupivacaine
- Keywords
- dexmedetomidine, magnesium sulphate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 1 μg/ kg
Magnesium SulphateDrug
Magnesium Sulphate 50 mg
BupivacaineDrug
1ml/kg of 0.25%of bupivacaine
Dexmedetomidine + Magnesium Sulphate + BupivacaineDrug
Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| group (MG) | Active comparator | Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine Receives: Drug: Magnesium Sulphate |
| group (D) | Active comparator | Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine Receives: Drug: Dexmedetomidine |
| group (MD) | Active comparator | 50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine Receives: Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine |
| group (C) | Active comparator | 1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement
The time from end of surgery to the first requirement of postoperative analgesia
Measured: 24 hours
Secondary outcomes (1)
Postoperative sedation scores
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals
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 posted1 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jehan ahmed sayed, Assiut University
- Investigators
- jehan A Sayed, MD, Principal investigator, assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487355
- Sponsor's protocol ID
- IRB000087123
- Acronym
- JASayed
- Status last verified
- Sep 2017
- First submitted
- 29 Jun 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT02487355
- Acronym / sponsor ID
- JASayed / IRB000087123
- Conditions
- Pain, Postoperative
- Keywords
- dexmedetomidine, magnesium sulphate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- 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 study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.
Detailed description
asdsd
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group (MG) | Active comparator | Drug: Magnesium SulphateMagnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine |
| group (D) | Active comparator | Drug: DexmedetomidineDexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine |
| group (MD) | Active comparator | Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine |
| group (C) | Active comparator | Drug: Bupivacaine1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block
Key exclusion criteria (1 listed)
- Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine 1 μg/ kg | Drug | group (D) |
| Magnesium SulphateMagnesium Sulphate 50 mg | Drug | group (MG) |
| Bupivacaine1ml/kg of 0.25%of bupivacaine | Drug | group (C) |
| Dexmedetomidine + Magnesium Sulphate + BupivacaineDexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine | Drug | group (MD) |
Primary outcome
Time to first analgesic requirement
Time frame: 24 hours
The time from end of surgery to the first requirement of postoperative analgesia
1 secondary outcome
Postoperative sedation scores
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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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.
jehan A Sayed, MD principal investigator
assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine, Magnesium Sulphate and Bupivacaine in people with Pain, Postoperative, run by Assiut 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 1 inclusion and 1 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 26 Sep 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jehan A Sayed, MD (+2 01006253939, jehan.alloul@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic requirement (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 26 Sep 2017.