Clinical trial NCT00355368: Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Official title: Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation
Keywords: intubation
intensive care
neuromuscular depolarizing agents
neuromuscular nondepolarizing agents
neuromuscular blocking agents
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-07-21
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Exhibiting Desaturation >5%
timeFrame: at any time between the start of the intubation sequence and 2min after the completion of intubation
Secondary outcomes:
measure: Haemodynamic Sequelae of Intubation
timeFrame: between start of induction sequence and 5 min after completion of intubation
measure: Time to Completion of Intubation
timeFrame: time interval between the injection of the induction agent and the first appearance of endtidal CO2
measure: 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.
timeFrame: during laryngoscopy and the first minute after completion of intubation
measure: Number of Participants With an Failed First Intubation Attempts
timeFrame: within the first 90 sec following the start of induction
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Medical Intensive Care; University of Basel
state: BS
Study officials:
affiliation: Department of Surgical Intensive Care, University of Basel
name: Martin Siegemund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Intensive Care, University of Basel
name: Stephan C Marsch, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):1356-1361. doi: 10.1213/01.ANE.0000180196.58567.FE.
citation: Marsch SC, Steiner L, Bucher E, Pargger H, Schumann M, Aebi T, Hunziker PR, Siegemund M. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial. Crit Care. 2011 Aug 16;15(4):R199. doi: 10.1186/cc10367.