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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Succinylcholine | Active Comparator |
| |
| Rocuronium | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Succinylcholine | Drug | 1mg/kg iv |
| |
| Rocuronium |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic Sequelae of Intubation | any new haemodynamic alteration requiring immediate intervention | between start of induction sequence and 5 min after completion of intubation |
| Time to Completion of Intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Intensive Care; University of Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16243994 | Background | 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. | |
| 21846380 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Succinylcholine | 1mg/kg |
| FG001 | Rocuronium | 0.6mg/kg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Succinylcholine | 1mg/kg |
| BG001 | Rocuronium | 0.6mg/kg |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Exhibiting Desaturation >5% | decrease of >5% in oxygen saturation measured continuously using pulse oxymetry | ITT | Posted | Number | participants | at any time between the start of the intubation sequence and 2min after the completion of intubation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Succinylcholine | 1mg/kg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Marsch | Medical Intensive care unit, University Hospital Basel | + 41 61 265 2525 | smarsch@uhbs.ch |
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| ID | Term |
|---|---|
| D013390 | Succinylcholine |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Drug |
0.6mg/kg iv |
|
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 |
| 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 |
| 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 |
| 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. |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Haemodynamic Sequelae of Intubation | any new haemodynamic alteration requiring immediate intervention | Not Posted | Number | participants | between start of induction sequence and 5 min after completion of intubation |
| Secondary | Time to Completion of Intubation | time interval between the injection of the induction agent and the first appearance of endtidal CO2 | Posted | Mean | Standard Deviation | seconds | time interval between the injection of the induction agent and the first appearance of endtidal CO2 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score points | during laryngoscopy and the first minute after completion of intubation |
|
|
|
| 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 | Posted | Number | participants | within the first 90 sec following the start of induction |
|
|
|
| 0 |
| 210 |
| 0 |
| 210 |
| EG001 | Rocuronium | 0.6mg/kg | 0 | 210 | 0 | 210 |
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| D009930 |
| Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |