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Does the stocktemperature of Rocuroniumbromide effect its working profile?


- candidate number10176
- NTR NumberNTR3040
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2011
- Secondary IDsNL36462.094.11 CCMO
- Public TitleDoes the stocktemperature of Rocuroniumbromide effect its working profile?
- Scientific TitleDoes the stocktemperature of Rocuroniumbromide effect its working profile?
- ACRONYMRocuroniumbromide
- hypothesisWe hypothesize that the Rocuroniumbromide working profile differs compared to other hospitals
- Healt Condition(s) or Problem(s) studiedAnesthesia, Rocuroniumbromide
- Inclusion criteria1. Startdose Rocuroniumbromide 0.3 mg / kg;
2. Aged 18 to 80 years, Mentally competent;
3. Elective surgery;
4. BMI between 20 to 35;
5. Maintain perioperative temperature between 20-35 degrees nasally measured;
6. Perioperatiece normoventilatie EtCO2 maintained between 32 and 40 mmHg;
7. Anesthesia with vaporous anesthetics;
8. Rocuroniumbromide will be dosed on ideal body weight, appropriate to height and weight;
9. Train of Four measurement takes place in the dominant arm of the patient.
- Exclusion criteria1. Fever;
2. Using succinyl during the procedure;
3. Dehydration;
4. Hypokaliamia <3.3;
5. Perioperative use of norepinephrine;
6. Patients with renal and hepatic defined as: Cockcroft clearance <50 and the presence of coagulation disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jul-2011
- planned closingdate15-okt-2011
- Target number of participants126
- InterventionsPatients will be divided in two groups. The patients in group A will get Rocuroniumbromide after storage in the refrigerator (2-8 degrees Celsius), the patients in the controlgroup (group B) receive Rocuroniumbromide at room temperature (21 degrees Celsius).
- Primary outcomePharmacodynamics of Rocuroniumbromide.
- Secondary outcome1. Does Rocuroniumbromide administered between 2-8 degrees Celsius change its working profile;
2. Does Rocuroniumbromide administered between 2-8 degrees Celsius over Rocuronium bromide 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 Rocuronium bromide of 2-8 degrees higher than in the greeting Rocuronium bromide at room temperature (21 degrees).
- TimepointsData collection takes place on one occasion, namely perioperative. In tranches of 10 patients being sought early and caused significant differences were demonstrated when it was a stopping criterion.
- Trial web siteN/A
- statusplanned
- 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 summaryWe investigate during general anesthesie in adults the working profile of rocuroniumbromide at two temperatures in order to find differrences.
- Main changes (audit trail)
- RECORD20-jul-2011 - 9-sep-2011


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