Spinal AnesthesiaPhase 4NCT01075490
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
A Phase 4 study testing clonidine in people with Spinal Anesthesia and Neonates, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection. Read more about this study
- Who is it for?
- Ages Up to 60 weeks
- Conditions the study is for
- Spinal Anesthesia, Neonates
- What is being tested?
- clonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to Dec 2009
- Phase
- Phase 4
- 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 Up to 60 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns less than 60 weeks old post-conceptional, former premature or not
- Newborns requiring inguinal hernia or lower limbs surgery,
- infants needing no more critical care assistance
- Informed consent of parents
Who cannot join
- Spinal malformation,
- Coagulopathy,
- critical hemodynamics,
- uncontrolled neurologic or metabolic pathology.
- infection at injection point.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier
Montpellier, 34295
Alain Rochette, MD, (33)467338256, a-rochette@chu-montpellier.fr
About this study
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.
Read the detailed description
Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.
- Conditions
- Spinal Anesthesia, Neonates
- Being tested
- clonidine
- Keywords
- spinal anesthesia, neonates, clonidine, post operative apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
clonidineDrug
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| prematurely born, bupivacaine, placebo | Placebo comparator | Not described Receives: Drug: clonidine |
| prematurely born, bupivacaine, clonidine | Experimental | Not described Receives: Drug: clonidine |
| term neonate, bupivacaine, placebo | Placebo comparator | Not described Receives: Drug: clonidine |
| term neonate, bupivacaine, clonidine | Experimental | Not described Receives: Drug: clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of "rescue" general anesthesia
Measured: end of surgery
Secondary outcomes (2)
apnea and desaturation occurrence
Measured: during 24h
duration of spinal anesthesia
Measured: during 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startNov 2006
- Primary completionNov 2006
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Investigators
- Xavier Capdevila, PhD, Study chair, CHU de Montpellier, FranceAlain Rochette, MD, Principal investigator, CHU de Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075490
- Sponsor's protocol ID
- UF7874
- Status last verified
- Jun 2009
- First submitted
- 12 May 2009
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.
PubMed 14693584Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7. doi: 10.1111/j.1460-9592.2005.01664.x.
PubMed 16324026
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
- ClinicalTrials.gov ID
- NCT01075490
- Acronym / sponsor ID
- UF7874
- Conditions
- Spinal Anesthesia, Neonates
- Keywords
- spinal anesthesia, neonates, clonidine, post operative apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 25 Feb 2010 (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.
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.
Detailed description
Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid "rescue" general anesthesia that occur in 20-40 % of patients with plain bupivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| prematurely born, bupivacaine, placebo | Placebo comparator | Drug: clonidine |
| prematurely born, bupivacaine, clonidine | Experimental | Drug: clonidine |
| term neonate, bupivacaine, placebo | Placebo comparator | Drug: clonidine |
| term neonate, bupivacaine, clonidine | Experimental | Drug: clonidine |
Who may qualify
- Ages
- Up to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns less than 60 weeks old post-conceptional, former premature or not
- Newborns requiring inguinal hernia or lower limbs surgery,
- infants needing no more critical care assistance
- Informed consent of parents
Key exclusion criteria (5 listed)
- Spinal malformation,
- Coagulopathy,
- critical hemodynamics,
- uncontrolled neurologic or metabolic pathology.
- infection at injection point.
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 |
|---|---|---|
| clonidineaddition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia | Drug | prematurely born, bupivacaine, clonidine, term neonate, bupivacaine, clonidine |
| clonidineequivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia | Drug | prematurely born, bupivacaine, placebo, term neonate, bupivacaine, placebo |
Primary outcome
number of "rescue" general anesthesia
Time frame: end of surgery
2 secondary outcomes
apnea and desaturation occurrence
Time frame: during 24h
duration of spinal anesthesia
Time frame: during 24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Background: PubMed 14693584Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.
- Background: PubMed 16324026Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7. doi: 10.1111/j.1460-9592.2005.01664.x.
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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.
Xavier Capdevila, PhD study chair
CHU de Montpellier, France
Alain Rochette, MD principal investigator
CHU de Montpellier, France
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 clonidine in people with Spinal Anesthesia and Neonates, run by University Hospital, Montpellier at 1 site in France.
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 5 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 Feb 2010. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Rochette, MD ((33)467338256, a-rochette@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of "rescue" general anesthesia (time frame: end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075490, which also lists 2 linked publications.
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 Feb 2010.