|- candidate number||19457|
|- NTR Number||NTR4789|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2014|
|- Secondary IDs|| |
|- Public Title||Recall of cardioversion after procedural sedation with propofol|
|- Scientific Title||Recall of cardioversion after procedural sedation with propofol|
|- hypothesis||Some patients have painful memories of the cardioversion even though they are sedated with propofol. |
|- Healt Condition(s) or Problem(s) studied||Arrhythmias, Cardioversion|
|- Inclusion criteria||Patients >18 years old, admitted for scheduled cardioversion of persistent arrhythmia|
|- Exclusion criteria||- An inability to understand the questions (eg, language problems) |
- Protein or soy intolerance
- Chronic pain
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2014|
|- planned closingdate||1-jun-2015|
|- Target number of participants||50|
|- Interventions||NRS-painscore before, directly after and some days after cardioversion|
|- Primary outcome||The incidence of a recall in patients who underwent cardioversion and were sedated with propofol |
|- Secondary outcome||The difference in NRS score (recall) directly after and some days after cardioversion|
|- Timepoints||1 Before cardioversion|
2 Directly after cardioversion
3 Some days after cardioversion
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.F.M. Winden, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.J.W. Dennesen|
|- Sponsor/Initiator ||Medisch Centrum Haaglanden|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)||30-jun-2017 -MT: |
The original pilot study is extended to a prospective multicenter study. In this study 223 patients were included. The primary outcome did not differ. The primary outcome was the incidence of painful recall of the ECV after sedation with propofol. Secondary outcomes were pain at the side of the defi-pads and muscle pain after the procedure.
Painful recall in elective electrical cardioversion with propofol and the need for additional analgesia.
Electrical cardioversion (ECV) is a short but painful procedure for treating cardiac dysrhythmias. There is a wide geographical variation regarding the medication strategy to facilitate this procedure. Many different anaesthetic techniques for ECV are described. Currently, the optimal medication strategy to prevent pain in ECV had yet to be established. The role for additional analgesic agents to prevent pain during the procedure remains controversial and evidence is limited.
We conducted a prospective multicenter study to determine the incidence of painful recall in ECV with propofol as a sole agent for sedation, in order to assess the indication for additional opioids. Exclusion criteria were suspected hypersensitivity to propofol. In all patients anaesthesia for ECV was induced with propofol titrated till loss of eyelash reflex and non-responsiveness to stimuli, corresponding to Ramsay Sedation Score level 5-6. ECV was performed with extracardiac biphasic electrical shocks. The primary outcome was painful recall of the procedure, defined as NRS ≥4. Secondary outcome parameters were pain at the side of the defi-pads and muscle pain after ECV.
A total of 226 patients were enrolled in this study. Six patients were excluded due to missing date or violation of study protocol. One patient (0.4%) reported recall of the procedure and NRS 7, despite adequate sedation with 90 mg propofol. Complete amnesia was observed in 223 patients, with NRS 0. The mean of the total dose of propofol was 1.1 mg. Fifteen patients (6.4%) experienced pain at the side of the defi-pads and six patients (0.9%) complained of muscle pain after the procedure.
In this prospective multicenter study, painful recall of the ECV was found in 0.4% of the patients. Propofol as a sole agent provided effective sedation and amnesia in 98,7 % of the patients. This data supports that additional opioids to propofol sedation is not indicated to prevent pain or recall in ECV.
|- RECORD||15-sep-2014 - 30-jun-2017|