Trial Outcomes & Findings for Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care (NCT NCT00355368)

Results Overview

decrease of \>5% in oxygen saturation measured continuously using pulse oxymetry

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

420 participants

Primary outcome timeframe

at any time between the start of the intubation sequence and 2min after the completion of intubation

Results posted on

2011-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	Succinylcholine 1mg/kg	Rocuronium 0.6mg/kg
Overall Study STARTED	210	210
Overall Study COMPLETED	200	201
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Succinylcholine 1mg/kg	Rocuronium 0.6mg/kg
Overall Study Protocol Violation	8	7
Overall Study cardiac arrest prior to intubation	2	2

Baseline Characteristics

Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Succinylcholine n=210 Participants 1mg/kg	Rocuronium n=210 Participants 0.6mg/kg	Total n=420 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	123 Participants n=5 Participants	108 Participants n=7 Participants	231 Participants n=5 Participants
Age, Categorical >=65 years	87 Participants n=5 Participants	102 Participants n=7 Participants	189 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 16 • n=5 Participants	63 years STANDARD_DEVIATION 14 • n=7 Participants	61 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	93 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	117 Participants n=7 Participants	236 Participants n=5 Participants
Region of Enrollment Switzerland	210 participants n=5 Participants	210 participants n=7 Participants	420 participants n=5 Participants

PRIMARY outcome

Timeframe: at any time between the start of the intubation sequence and 2min after the completion of intubation

Population: ITT

decrease of \>5% in oxygen saturation measured continuously using pulse oxymetry

Outcome measures

Outcome measures
Measure	Succinylcholine n=200 Participants	Rocuronium n=200 Participants
Number of Participants Exhibiting Desaturation >5%	73 participants	66 participants

SECONDARY outcome

Timeframe: between start of induction sequence and 5 min after completion of intubation

any new haemodynamic alteration requiring immediate intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Succinylcholine n=200 Participants	Rocuronium n=200 Participants
Time to Completion of Intubation	81 seconds Standard Deviation 38	95 seconds Standard Deviation 48

SECONDARY outcome

Timeframe: during laryngoscopy and the first minute after completion of intubation

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

Outcome measures

Outcome measures
Measure	Succinylcholine n=200 Participants	Rocuronium n=200 Participants
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.	8.3 score points Standard Deviation 0.8	8.2 score points Standard Deviation 0.9

SECONDARY outcome

Timeframe: within the first 90 sec following the start of induction

defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt

Outcome measures

Outcome measures
Measure	Succinylcholine n=200 Participants	Rocuronium n=200 Participants
Number of Participants With an Failed First Intubation Attempts	32 participants	36 participants

Adverse Events

Succinylcholine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rocuronium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan Marsch

Medical Intensive care unit, University Hospital Basel

Phone: + 41 61 265 2525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place