Intubation Conditions
Conditions
Brief summary
The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.
Detailed description
Elderly patients are frail and susceptible to complications in the perioperative period. They are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA). The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation. It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.
Interventions
DRUGSuxamethonium
1 mg/kg for tracheal intubation after 60 seconds
DRUGRocuronium
1 mg/kg for tracheal intubation after 60 seconds
Sponsors
Matias Vested
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized study
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 80 * Scheduled for surgery under general anesthesia with indication for rapid sequence induction * American Society of Anesthesiologists physical status classification (ASA) I to IV * Informed consent (see appendix 1) * Body mass index (BMI) \< 35 kg/m2 * Read and understand Danish
Exclusion criteria
* Neuromuscular disease * Known allergy to rocuronium and/or suxamethonium * Known hyperkalemia \> 5 mM * Previous malignant hyperthermia * Known homozygote plasmacholinesterase gene mutation variant a or s * Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) \< 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation conditions | 60 seconds after induction of anaesthesia | Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to TOF count 0 | within 15 minutes | Time till no response from the nerve-stimulator after administration of muscle relaxant |
| First pas succes rate | within 15 minutes | Succes of tracheal tube placement 60 seconds after administration of muscle relaxant |
| Intubation conditions | within 15 minutes | Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst) |
| Time to tracheal intubation | within 15 minutes after administration of muscle relaxant | • Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube) |
| cardiac arrythmia | within 15 minutes of anesthesia | Occurrence of new cardiac arrythmia during induction of anaesthesia (\<15 minutes from administration of muscle relaxant) |
| sore throat | 24 hours after anaesthesia | blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst) |
| muscle soreness | 24 hours after anaesthesia | blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst) |
| Desaturation | within 15 minutes | spO2 \< 0.9 |
Countries
Denmark
Outcome results
None listed