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NCT Number: NCT04868409

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

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.

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Key information

Conditions

Intubation Conditions

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suxamethonium

Drug

1 mg/kg for tracheal intubation after 60 seconds

Other names: Succinylcholine

Rocuronium

Drug

1 mg/kg for tracheal intubation after 60 seconds

Other names: Esmeron

Primary outcomes

  1. 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

  1. Time to tracheal intubation

    Time frame: within 15 minutes after administration of muscle relaxant

    • Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube)

  2. Time to TOF count 0

    Time frame: within 15 minutes

    Time till no response from the nerve-stimulator after administration of muscle relaxant

  3. First pas succes rate

    Time frame: within 15 minutes

    Succes of tracheal tube placement 60 seconds after administration of muscle relaxant

  4. Intubation conditions

    Time frame: within 15 minutes

    Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst)

  5. Desaturation

    Time frame: within 15 minutes

    spO2 < 0.9

  6. cardiac arrythmia

    Time frame: within 15 minutes of anesthesia

    Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of muscle relaxant)

  7. sore throat

    Time frame: 24 hours after anaesthesia

    blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst)

  8. muscle soreness

    Time frame: 24 hours after anaesthesia

    blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst)

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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