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Pharmacodynamics of pancuronium during therapeutic hypothermia.


- candidate number10455
- NTR NumberNTR3115
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2011
- Secondary IDs 
- Public TitlePharmacodynamics of pancuronium during therapeutic hypothermia.
- Scientific TitleNeuromuscular recovery following 24h of pancuronium infusion during post-resuscitation therapeutic hypothermia– an observational prospective study.
- ACRONYMPANCOOL
- hypothesisHow long is the (median) duration from discontinuation of pancuronium after approximately 24h infusion until neuromuscular recovery to a TOF 0.9 in patients treated with therapeutic hypothermia after cardiac arrest?
- Healt Condition(s) or Problem(s) studiedCardiac arrest, Therapeutic hypothermia, Neuromuscular blockade, Pancuroniumbromide
- Inclusion criteriaPatient criteria:
1. Age > 18 years.

Cooling criteria:
1. Witnessed cardiac arrest;
2. Initial cardiac rhythm being VF/VT;
3. Delay from arrest till start CPR >5min, <15min;
4. Time from arrest till return of spontaneous circulation (ROSC) <60min;
5. Start cooling within 6 hours after ROSC.
- Exclusion criteriaExclusion from cooling (MUMC based):
1. Cardiac shock >30min after ROSC;
2. Coma before cardiac arrest;
3. Other cause of coma (CVA, trauma, intoxication);
4. Hypothermia on arrival at emergency department (<30 degrees Celsius);
5. Verbal reaction after ROSC;
6. Pregnancy;
7. Persistent hypoxia (SpO2<85%) >15min after ROSC;
8. Terminal disease state;
9. Pre-existing coagulation disorders (trombolysis is no contra-indication);
10. Persistent ventricular arrhythmias.

Exclusion because of study criteria:
1. Age < 18 years;
2. Contraindications for use of pancuronium;
3. No option for neuromuscular monitoring on at least one hand;
4. Use of confounding medication (anticonvulsants, steroid therapy, verapamil or aminoglycosides);
5. Renal failure;
6. Liver failure;
7. Neuromuscular diseases;
8. Use of other neuromuscular relaxants than pancuronium.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate
- Target number of participants10
- InterventionsPancuroniumbromide infusion during 24 hours.
- Primary outcomeMedian during untill TOF ratio 0.9 after 24 hours of pancuroniumbromide infusion.
- Secondary outcomeN/A
- TimepointsTime of injection pancuronium (time 0);
Injection pancuronium – TOF ratio 0.7;
Injection pancuronium – TOF ratio 0.9;
Injection pancuronium – TOF ratio 1.0;
TOF ratio at planned discontinuation of sedation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. L.P.W. Mommers
- CONTACT for SCIENTIFIC QUERIESMD. L.P.W. Mommers
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryAfter cardiopulmonary resuscitation (CPR) is a nowadays common to treat survivors with therapeutic hypothermia for 24-48h. A lot of intensive care units use pancuroniumbromide as muscle relaxants during this therapeutic hypothermia. From normothermic patients we know there is a large interindividual variance in duration of action. After CPR and during hypothermia even more factors can be associated with a prolonged action of pancuroniumbromide. Therefore we want to conduct this observational trial, to measure the duration of action of pancuroniumbromide when given for 24h during therapeutic hypothermia after CPR.
- Main changes (audit trail)
- RECORD19-okt-2011 - 3-nov-2011


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