Clinical trial NCT04868409: Intubating Conditions During Rapid Sequence Induction in Elderly With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Conditions
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 102
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intubation conditions
timeFrame: 60 seconds after induction of anaesthesia
Secondary outcomes:
measure: Time to tracheal intubation
timeFrame: within 15 minutes after administration of muscle relaxant
measure: Time to TOF count 0
timeFrame: within 15 minutes
measure: First pas succes rate
timeFrame: within 15 minutes
measure: Intubation conditions
timeFrame: within 15 minutes
measure: Desaturation
timeFrame: within 15 minutes
measure: cardiac arrythmia
timeFrame: within 15 minutes of anesthesia
measure: sore throat
timeFrame: 24 hours after anaesthesia
measure: muscle soreness
timeFrame: 24 hours after anaesthesia
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Glostrup
country: Denmark
facility: Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup
city: Holbæk
country: Denmark
facility: Holbæk Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars S Rasmussen
role: STUDY_CHAIR
References: