Intubation
Conditions
Keywords
intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents
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.
Interventions
DRUGSuccinylcholine
1mg/kg iv
DRUGRocuronium
0.6mg/kg iv
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exhibiting Desaturation >5% | at any time between the start of the intubation sequence and 2min after the completion of intubation | decrease of \>5% in oxygen saturation measured continuously using pulse oxymetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamic Sequelae of Intubation | between start of induction sequence and 5 min after completion of intubation | any new haemodynamic alteration requiring immediate intervention |
| 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 |
| 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. | 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 |
| Number of Participants With an Failed First Intubation Attempts | 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 |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Succinylcholine 1mg/kg | 210 |
| Rocuronium 0.6mg/kg | 210 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | cardiac arrest prior to intubation | 2 | 2 |
| Overall Study | Protocol Violation | 8 | 7 |
Baseline characteristics
| Characteristic | Rocuronium | Succinylcholine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 102 Participants | 87 Participants | 189 Participants |
| Age, Categorical Between 18 and 65 years | 108 Participants | 123 Participants | 231 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 15 |
| Region of Enrollment Switzerland | 210 participants | 210 participants | 420 participants |
| Sex: Female, Male Female | 93 Participants | 91 Participants | 184 Participants |
| Sex: Female, Male Male | 117 Participants | 119 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 210 | 0 / 210 |
| serious Total, serious adverse events | 0 / 210 | 0 / 210 |
Outcome results
Primary
Number of Participants Exhibiting Desaturation >5%
decrease of \>5% in oxygen saturation measured continuously using pulse oxymetry
Time frame: at any time between the start of the intubation sequence and 2min after the completion of intubation
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Succinylcholine | Number of Participants Exhibiting Desaturation >5% | 73 participants |
| Rocuronium | Number of Participants Exhibiting Desaturation >5% | 66 participants |
Secondary
Haemodynamic Sequelae of Intubation
any new haemodynamic alteration requiring immediate intervention
Time frame: between start of induction sequence and 5 min 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
Time frame: within the first 90 sec following the start of induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Succinylcholine | Number of Participants With an Failed First Intubation Attempts | 32 participants |
| Rocuronium | Number of Participants With an Failed First Intubation Attempts | 36 participants |
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
Time frame: during laryngoscopy and the first minute after completion of intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Succinylcholine | 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 |
| Rocuronium | 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. | 8.2 score points | Standard Deviation 0.9 |
Secondary
Time to Completion of Intubation
time interval between the injection of the induction agent and the first appearance of endtidal CO2
Time frame: time interval between the injection of the induction agent and the first appearance of endtidal CO2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Succinylcholine | Time to Completion of Intubation | 81 seconds | Standard Deviation 38 |
| Rocuronium | Time to Completion of Intubation | 95 seconds | Standard Deviation 48 |