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NCT Number: NCT04287426

A Comparison of Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in Elderly Patients Over 80 Years

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.

Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.

It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

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Key information

Conditions

Neuromuscular Blockade Anesthesia Intubation Complication

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Copenhagen, Denmark

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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.

During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions.

Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.

The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients.

The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Neuromuscular disease
  • Known allergy to rocuronium, remifentanil or sugammadex
  • Rapid sequence induction

Treatment and study plan

Rocuronium 0.6 mg/kg

Drug

Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil

Remifentanil 2 µg/kg

Drug

Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil

Primary outcomes

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

    Time frame: 2 minutes after start of administration of trial medication

    Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor.

Secondary outcomes

  1. Subjective side effects of laryngoscopy

    Time frame: 24 hours postoperatively and 3 days postoperatively

    After 24 hours patients are asked about hoarseness and sore throat. The patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale.

  2. Dose of ephedrine or dose of metaoxedrine administered

    Time frame: From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.

    If ephedrine and/or metaoxedrine is administered in the time period from induction until the patient is ready to be positioned for surgery it will be noted in the CRF. The amount administered will also be noted in the CRF. Changes in blood pressure are treated according to local guidelines.

  3. Intubating conditions according to IDS

    Time frame: 2 minutes after start of administration of trial medication

    Another way of rating intubating conditions are by an intubating difficulty scale (Table 2) (20) 2 minutes after injection of rocuronium/remifentanil. The investigator performing the intubation will be handed the CRF where he/she will fill out Table 2. Furthermore, investigator will note if a stylet or video laryngoscope has been used.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Dec 22, 2020

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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