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A Pilot Study to Investigate Plasma Bupivacaine Concentrations in Children Receiving Total Intravenous Anaesthesia and Caudal Analgesia

NCT01216007 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-26

No results posted yet for this study

Summary

The objective of this pilot study is to compare plasma \[bupivacaine\] between two groups of paediatric patients under general anaesthesia who will all receive regional caudal anaesthesia with bupivacaine: group 1 will receive TIVA and group 2 will receive a volatile anaesthetic.

Conditions

  • Anesthesia

Interventions

DRUG

propofol

In the TIVA group, IV access will be obtained as per BCCH routine, with caregiver present. 2% lidocaine 1 mg/kg will be administered via IV to prevent venous pain before induction of anaesthesia with propofol, as per BCCH standard. Induction of anaesthesia will be achieved with an IV bolus of propofol 5 mg/kg and remifentanil 2.5 mcg/kg. Anaesthesia will be maintained with an infusion of propofol 200-400 mcg/kg/min and remifentanil 0.1-0.2 mcg/kg/min. Once the subject is under general anaesthesia, the anaesthesiologist will place a second IV cannula, specifically for the collection of blood samples. This cannula will not be in the same limb as the propofol infusion.

DRUG

sevoflurane

In the volatile anaesthesia group, induction of anaesthesia will be achieved with inhalation of sevoflurane (5-8% in O2/air). Maintenance of anaesthesia will continue with a volatile agent of the anaesthesiologist's choice.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Simon Whyte, Dr. · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216007 on ClinicalTrials.gov