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Effects of administration temperature and gender on the effects of atracurium dibesilate (tracrium).


- candidate number14357
- NTR NumberNTR3856
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2013
- Secondary IDsNL.40341.094.12 CCMO
- Public TitleEffects of administration temperature and gender on the effects of atracurium dibesilate (tracrium).
- Scientific TitleEffects of administration temperature and gender on the pharmacokinetics of atracurium dibesilate (tracrium).
- ACRONYMadimistration temperature, atracurium, pharmacodynamics
- hypothesisWe hypothesized that the administration temperature of atracurium may effect pharmacodynamics in our daily practice.
- Healt Condition(s) or Problem(s) studiedGeneral anesthesia, Atracurium dibesilaat, Tracrium
- Inclusion criteria1. Atracurium dose during induction 0,23mg/kg;
2. Age between 18 and 80 yrs;
3. Mentally competent;
4. Elective surgery;
5. BMI between 20 and 35;
6. Perioperative temperature between 35 and 38 degrees C;
7. Perioperative normoventilation (EtCO2 between 32 and 40mmHg);
8. Train of Four measurement on dominant side of the patient.
- Exclusion criteria1. Fever;
2. Use of succinyl;
3. Hypokaliemie (< 3,3);
4. Dehydration;
5. Clotting diseases;
6. Peri-operative ketamine;
7. Pre operative use of fenytoine or carbamazepine.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2012
- planned closingdate1-jun-2013
- Target number of participants126
- InterventionsPatients are divided into two groups and either receive atracurium directly at room temperature (20 degrees) or refrigerator temperature (2-8 degrees).

The duration of the intervention stops directly after general anesthesia is ended. Patients will be a study patient untill they wake up.
- Primary outcomePharmacodynamics of atracurium, measured at 1, 5, 10, 15 30, 45 and 60 minutes with the train of four.
- Secondary outcome1. Does atracurium administered between 2-8 degrees Celsius change TOF;
2. Does atracurium administered between 2-8 degrees Celsius over atracurium at room temperature (21 degrees) change its working profile;
3. Is the intensity measured after train of four 1, 5, 10, 15, 30, 45 and 60 minutes after administration of atracurium of 2-8 degrees higher than in the atracurium at room temperature (20 degrees);
4. Is there any difference between gender on secondary outcomes?
- Timepoints1. Peri-operative measurement;
2. Postoperative data extraction.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H. Zonneveldt
- CONTACT for SCIENTIFIC QUERIES H. Zonneveldt
- Sponsor/Initiator Westfriesgasthuis Hoorn
- Funding
(Source(s) of Monetary or Material Support)
Westfriesgasthuis Hoorn
- PublicationsN/A
- Brief summaryDuring general anesthesia we measure with the Train of four the percentage muscle relaxant intensity in two groups with administration temperature of the muscle relaxant as intervention.
- Main changes (audit trail)
- RECORD11-feb-2013 - 26-feb-2013


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