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)
Overview
- Phase
- Phase 4
- Intervention
- Rocuronium
- Conditions
- Intubation Conditions
- Sponsor
- Matias Vested
- Enrollment
- 102
- Locations
- 4
- Primary Endpoint
- Intubation conditions
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Matias Vested
MD PhD
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Rocuronium group
Rocuronium 1 mg/kg
Intervention: Rocuronium
Suxamethonium group
Suxamethonium 1 mg/kg
Intervention: Suxamethonium
Outcomes
Primary Outcomes
Intubation conditions
Time Frame: 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 Outcomes
- Time to TOF count 0(within 15 minutes)
- Desaturation(within 15 minutes)
- Time to tracheal intubation(within 15 minutes after administration of muscle relaxant)
- cardiac arrythmia(within 15 minutes of anesthesia)
- First pas succes rate(within 15 minutes)
- Intubation conditions(within 15 minutes)
- sore throat(24 hours after anaesthesia)
- muscle soreness(24 hours after anaesthesia)