Anesthesia Clinical Trial
Official title:
A Pilot Study to Investigate Plasma Bupivacaine Concentrations in Children Receiving Total Intravenous Anaesthesia and Caudal Analgesia
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.
Hypothesis:
The investigators hypothesize that there will be a detectable difference in free plasma
[bupivacaine] between these two treatment groups, with lower free plasma [bupivacaine] in
the TIVA group.
Background:
Local anesthetics (LA) are frequently administered intra-operatively, in combination with
general anaesthesia, for pain management in children. Although highly effective in this
regard, LAs possess a narrow margin of safety. High plasma levels can cause toxicity in both
the central nervous system (CNS) and the cardiovascular system (CVS) and may result from
either the correct placement of an excessive dose or an inadvertent intravenous (IV)
injection of a correct dose.
Specific Objectives:
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.
Methods:
Induction of anesthesia: The TIVA group will receive the BCCH standard regimen comprising
induction with propofol 5 mg/kg and remifentanil 2.5 mcg/kg, followed by maintenance
infusion of propofol 200-400 mcg/kg/min and remifentanil 0.1-0.2 mcg/kg/min. Total
cumulative Intralipid® doses will be recorded at times of caudal injection and blood
sampling. The volatile anesthesia group will undergo inhalational induction with sevoflurane
in oxygen, followed by maintenance with a volatile agent of the anesthesiologist's choice.
In both groups, airway management will be at the discretion of the anesthesiologist.
Standard minimum monitoring will be applied. A caudal epidural will then be performed using
a standard technique.
Administration of caudal analgesia and whole blood sampling: A caudal dose of 1 ml/kg of
0.25% bupivacaine (2.5 mg/kg) with 1 in 200 000 epinephrine will be administered at time
zero (T0). Venous blood samples of 5 ml will be obtained from a second indwelling IV cannula
15 (T1) and 30 (T2) min after caudal injection. These will be collected into EDTA-containing
tubes by the PART research assistant and transferred to the BCCH pharmacy research
technician (blinded to anesthetic technique) for analysis. Blood samples will be immediately
centrifuged. The extracted plasma will be frozen at -850C. Total and free bupivacaine plasma
concentrations will be determined using high-pressure liquid chromatography (HPLC) and
ultrafiltration.
Data Analysis:
This pilot study will have two primary outcome measures, total and free plasma bupivacaine
concentrations. These data will be presented as mean (± SD) at T1 and T2. Normal
distribution will be tested by histogram plot. Between-group (TIVA vs. volatile anaesthesia)
comparisons of total and free plasma bupivacaine levels will be performed using appropriate
analyses of variance. This analysis will determine if there is a detectable difference in
plasma concentrations between the TIVA and volatile anaesthesia groups. These data will then
be used in a power calculation to determine necessary group sizes for a future randomized
controlled trial (RCT) study. Statistical analysis will be conducted using Analyse-It®
(Analyse-It Software, Leeds, UK) in consultation with a statistician (Clinical Research
Statistical Unit).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04580030 -
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
|
||
| Active, not recruiting |
NCT04279054 -
Decreased Neuraxial Morphine After Cesarean Delivery
|
Early Phase 1 | |
| Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
| Recruiting |
NCT04099693 -
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
|
||
| Terminated |
NCT02481999 -
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
|
||
| Completed |
NCT04235894 -
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
|
||
| Recruiting |
NCT05525104 -
The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).
|
N/A | |
| Recruiting |
NCT05024084 -
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
|
Phase 4 | |
| Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
| Completed |
NCT03277872 -
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
|
N/A | |
| Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
| Terminated |
NCT02529696 -
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
|
||
| Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
| Terminated |
NCT03704285 -
Development of pk/pd Model of Propofol in Patients With Severe Burns
|
||
| Recruiting |
NCT05259787 -
EP Intravenous Anesthesia in Hysteroscopy
|
Phase 4 | |
| Completed |
NCT02894996 -
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
|
N/A | |
| Completed |
NCT05386082 -
Anesthesia Core Quality Metrics Consensus Delphi Study
|
||
| Terminated |
NCT03567928 -
Laryngeal Mask in Upper Gastrointestinal Procedures
|
N/A | |
| Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
| Completed |
NCT04163848 -
CARbon Impact of aNesthesic Gas
|