A Phase 4 interventional study of Suxamethonium and Rocuronium in Intubation Conditions, sponsored by Matias Vested. Completed at 4 sites in Denmark. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Matias Vested · Phase 4, Interventional, and Treatment
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.
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.
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This study's enrollment of 102 is above the median of 80 across 732 interventional studies indexed under Disease.
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Exclusion Criteria:
Rocuronium 1 mg/kg
Drug: Rocuronium
Suxamethonium 1 mg/kg
Drug: Suxamethonium
1 mg/kg for tracheal intubation after 60 seconds
Also known as: Succinylcholine
1 mg/kg for tracheal intubation after 60 seconds
Also known as: Esmeron
Intubation conditions
Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation,
Time frame: 60 seconds after induction of anaesthesia
Time to tracheal intubation
• Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube)
Time frame: 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
Time frame: within 15 minutes
First pas succes rate
Succes of tracheal tube placement 60 seconds after administration of muscle relaxant
Time frame: within 15 minutes
Intubation conditions
Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst)
Time frame: within 15 minutes
Desaturation
spO2 \< 0.9
Time frame: within 15 minutes
cardiac arrythmia
Occurrence of new cardiac arrythmia during induction of anaesthesia (\<15 minutes from administration of muscle relaxant)
Time frame: 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)
Time frame: 24 hours after anaesthesia
muscle soreness
blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst)
Time frame: 24 hours after anaesthesia
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Matias Vested