Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care|
- Number of Participants Exhibiting Desaturation >5% [ Time Frame: at any time between the start of the intubation sequence and 2min after the completion of intubation ] [ Designated as safety issue: Yes ]decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
- Haemodynamic Sequelae of Intubation [ Time Frame: between start of induction sequence and 5 min after completion of intubation ] [ Designated as safety issue: Yes ]any new haemodynamic alteration requiring immediate intervention
- Time to Completion of Intubation [ Time Frame: time interval between the injection of the induction agent and the first appearance of endtidal CO2 ] [ Designated as safety issue: No ]time interval between the injection of the induction agent and the first appearance of endtidal CO2
- 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. [ Time Frame: during laryngoscopy and the first minute after completion of intubation ] [ Designated as safety issue: No ]
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
- Number of Participants With an Failed First Intubation Attempts [ Time Frame: within the first 90 sec following the start of induction ] [ Designated as safety issue: No ]defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt
|Study Start Date:||August 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Succinylcholine||
|Active Comparator: Rocuronium||
Objective: 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.
Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).
Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355368
|Department of Medical Intensive Care; University of Basel|
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Martin Siegemund, MD||Department of Surgical Intensive Care, University of Basel|
|Principal Investigator:||Stephan C Marsch, MD, DPhil||Department of Medical Intensive Care, University of Basel|