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NCT Number: NCT04512313

A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.

The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.

During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

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Key information

Conditions

Neuromuscular Blockade Anesthesia Delayed Emergence from Anesthesia Intubation Complication Neuromuscular Blockade, Residual Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients 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.

Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.

Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.

The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 80
  • Scheduled to elective surgery (expected duration time of surgery > 1 hour) under general anesthesia with intubation and use of rocuronium.
  • American Society of Anesthesiologists (ASA) physical status classification I to III
  • Informed consent (see appendix 1)
  • Read and understand Danish

Exclusion criteria

  • Neuromuscular disease
  • Known allergy to rocuronium
  • Prone position
  • Indication for rapid sequence induction

Treatment and study plan

Rocuronium 0,3mg/kg

Drug

Rocuronium 0,3mg/kg at induction

Other names: Rocuronium

Rocuronium 0,9mg/kg

Drug

Rocuronium 0,9mg/kg at induction

Other names: Rocuronium

Primary outcomes

  1. Rocuronium onset time

    Time frame: intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)

    Time from start of rocuronium injection to train-of-four (TOF) count of 0

Secondary outcomes

  1. Duration of action of rocuronium

    Time frame: intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)

    Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.

  2. Evaluation of intubating conditions ad modum Fuchs-Buder et al

    Time frame: intraoperative (From train-of-four (TOF) count of 0 till)

    Intubating conditions are rated by an intubating difficulty scale according to Fuchs-Buder et al.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

A Single-blinded Multicenter Randomized Interventional Study of Rocuronium 0.3 mg/kg, and 0.9 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Elderly Patients (≥ 80 Years).

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Jun 3, 2021

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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