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

NCT01216007 | Completed Phase 1 DMC

• 1 other identifier: H10-01501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Plasma; bupivacaine; concentration; caudal; epidural; TIVA; Inhalational; anesthesia; Caudal epidural

Outcome Measures

Primary Outcomes (1)

• Total and free plasma bupivacaine concentrations

  5 mL blood sample will be obtained at 15 and 30min. Total and free plasma bupivacaine concentrations

Study Arms (2)

TIVA

ACTIVE COMPARATOR

TIVA

Drug: propofol

Inhalational

ACTIVE COMPARATOR

Inhalational/volatile general anesthetic

Drug: sevoflurane

Interventions

propofol DRUG

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.

TIVA

sevoflurane DRUG

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.

Inhalational

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months - 5 years
• ASA I-II
• Undergoing elective day surgery for which combined general and caudal epidural anaesthesia is indicated
• Written parental/guardian informed consent

You may not qualify if:

• Weight and body mass index \< 3rd or \> 97th percentile for age
• Any contraindication to caudal injection
• Renal, hepatic, neuromuscular or cardiac disease
• Acute inflammatory process or infectious processes that provoke an acute phase response, ongoing or resolved less than 2 weeks prior to recruitment day (such as recent surgery, respiratory tract infection (including colds), urinary tract infection, infectious or inflammatory gastroenteritis, otitis media, skin or wound infection, cholecystitis, pancreatitis, hepatitis, meningitis) Chronic co-existing inflammatory diseases (eg, inflammatory bowel disease, juvenile arthritis, cystic fibrosis, autoimmune disease, connective tissue disease, chronic liver disease)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital, Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Simon Whyte, Dr.

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

CA (1)