Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT01075490

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia Neonates	Drug: clonidine Drug: clonidine	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: prematurely born, bupivacaine, placebo	Drug: clonidine equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Experimental: prematurely born, bupivacaine, clonidine	Drug: clonidine addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Placebo Comparator: term neonate, bupivacaine, placebo	Drug: clonidine equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Experimental: term neonate, bupivacaine, clonidine	Drug: clonidine addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia

Outcome Measures

Primary Outcome Measures

number of "rescue" general anesthesia [end of surgery]

Secondary Outcome Measures

apnea and desaturation occurrence [during 24h]
duration of spinal anesthesia [during 24h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Spinal malformation,
Coagulopathy,
critical hemodynamics,
uncontrolled neurologic or metabolic pathology.
infection at injection point.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Montpellier	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Study Chair: Xavier Capdevila, PhD, CHU de Montpellier, France
Principal Investigator: Alain Rochette, MD, CHU de Montpellier, France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01075490

Other Study ID Numbers:

UF7874

First Posted:

Feb 25, 2010

Last Update Posted:

Feb 25, 2010

Last Verified:

Jun 1, 2009

Keywords provided by , ,

Additional relevant MeSH terms:

Clonidine

Study Results

No Results Posted as of Feb 25, 2010