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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prematurely born, bupivacaine, placebo | Placebo Comparator |
| |
| prematurely born, bupivacaine, clonidine | Experimental |
| |
| term neonate, bupivacaine, placebo | Placebo Comparator |
| |
| term neonate, bupivacaine, clonidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clonidine | Drug | addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of "rescue" general anesthesia | end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| apnea and desaturation occurrence | during 24h | |
| duration of spinal anesthesia | during 24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Rochette, MD | Contact | (33)467338256 | a-rochette@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Capdevila, PhD | CHU de Montpellier, France | Study Chair |
| Alain Rochette, MD | CHU de Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14693584 | Background | 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. | |
| 16324026 | Background | Rochette 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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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| clonidine | Drug | equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia |
|
| D006571 |
| Heterocyclic Compounds |