Intubating Conditions During Rapid Sequence Induction in Elderly With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Blinded Multicenter Randomized Study Comparing Intubating Conditions During Rapid Sequence Induction With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg in Elderly Patients (≥ 80 Years Old)

Conditions
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Intubation Conditions

Intervention / Treatment
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* Drug: Suxamethonium
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium group<br>Rocuronium 1 mg/kg | Drug: Rocuronium<br>* 1 mg/kg for tracheal intubation after 60 seconds<br>* Other names: Esmeron;|
| Active Comparator: Suxamethonium group<br>Suxamethonium 1 mg/kg | Drug: Suxamethonium<br>* 1 mg/kg for tracheal intubation after 60 seconds<br>* Other names: Succinylcholine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation conditions | Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation, | 60 seconds after induction of anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tracheal intubation | • Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube) | within 15 minutes after administration of muscle relaxant | 
| Time to TOF count 0 | Time till no response from the nerve-stimulator after administration of muscle relaxant | within 15 minutes | 
| First pas succes rate | Succes of tracheal tube placement 60 seconds after administration of muscle relaxant | within 15 minutes | 
| Intubation conditions | Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst) | within 15 minutes | 
| Desaturation | spO2 < 0.9 | within 15 minutes | 
| cardiac arrythmia | Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of muscle relaxant) | within 15 minutes of anesthesia | 
| sore throat | blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst) | 24 hours after anaesthesia | 
| muscle soreness | blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst) | 24 hours after anaesthesia |