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Atropine-effect during propofol/remifentanil induction.


- candidate number13339
- NTR NumberNTR3622
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2012
- Secondary IDs2012/218 METC UMCG
- Public TitleAtropine-effect during propofol/remifentanil induction.
- Scientific TitleEvaluation of the beneficial effects of the administration of atropine during propofol/remifentanil induction of general anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation.
- ACRONYM
- hypothesisWe hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.
- Healt Condition(s) or Problem(s) studiedGeneral anesthesia, Tissue oxygenation, Hemodynamics
- Inclusion criteria1. Patients requiring general anaesthesia;
2. Patients age 18 years and older;
3. Patient and surgical procedure appropriate for treatment with atropine.
- Exclusion criteria1. Patients refusal;
2. Pregnancy;
3. Patients age < 18 years;
4. Patients in which atropine is contra-indicated.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-sep-2012
- planned closingdate31-dec-2013
- Target number of participants60
- InterventionsAll patients will receive a standard anesthesia based on propofol and remifentanil. During the induction of anesthesia patients will randomly receive either atropine 500ug or saline. If necessary, hemodynamic support will be provided by continuous infusion of norepinephrine as in normal clinical practice to maintain adequate perfusion pressure defined as mean arterial pressure 60 mmHg. Hemodynamic parameters as well as peripheral and cerebral tissue oxygenation and microvascular blood flow will be monitored noninvasively and recorded.
- Primary outcomeHemodynamics and tissue oxygenation.
- Secondary outcomeRequirement of other vasoactive medication.
- TimepointsDay of surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIES A.F. Kalmar
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-sep-2012 - 18-okt-2012


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