Intubation Clinical Trial
Official title:
Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
Verified date | November 2011 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Status | Completed |
Enrollment | 420 |
Est. completion date | July 2010 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - indication for emergency intubation in intensive care - availability of qualified study physician Exclusion Criteria: - contraindication against succinylcholine or rocuronium - indication for awake fibreoptic intubation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Medical Intensive Care; University of Basel | Basel | BS |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Sluga M, Ummenhofer W, Studer W, Siegemund M, Marsch SC. Rocuronium versus succinylcholine for rapid sequence induction of anesthesia and endotracheal intubation: a prospective, randomized trial in emergent cases. Anesth Analg. 2005 Nov;101(5):1356-61. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Exhibiting Desaturation >5% | decrease of >5% in oxygen saturation measured continuously using pulse oxymetry | at any time between the start of the intubation sequence and 2min after the completion of intubation | Yes |
Secondary | Haemodynamic Sequelae of Intubation | any new haemodynamic alteration requiring immediate intervention | between start of induction sequence and 5 min after completion of intubation | Yes |
Secondary | Time to Completion of Intubation | time interval between the injection of the induction agent and the first appearance of endtidal CO2 | time interval between the injection of the induction agent and the first appearance of endtidal CO2 | No |
Secondary | Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74. | The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3. Units: measure on a scale |
during laryngoscopy and the first minute after completion of intubation | No |
Secondary | Number of Participants With an Failed First Intubation Attempts | defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt | within the first 90 sec following the start of induction | No |
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