Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

February 24, 2010 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of "rescue" general anesthesia
Time Frame: end of surgery
end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
apnea and desaturation occurrence
Time Frame: during 24h
during 24h
duration of spinal anesthesia
Time Frame: during 24h
during 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF7874

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Anesthesia

Clinical Trials on clonidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe