Clinical trial NCT04287426: A Comparison of Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in Elderly Patients Over 80 Years
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Intubation Complication
Anesthesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 78
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of intubating conditions ad modum Fuchs-Buder et al
timeFrame: 2 minutes after start of administration of trial medication
Secondary outcomes:
measure: Subjective side effects of laryngoscopy
timeFrame: 24 hours postoperatively and 3 days postoperatively
measure: Dose of ephedrine or dose of metaoxedrine administered
timeFrame: From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.
measure: Intubating conditions according to IDS
timeFrame: 2 minutes after start of administration of trial medication
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Glostrup
country: Denmark
facility: Rigshospitalet, Glostrup
Study officials:
affiliation: Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark
name: Matias Vested, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark
name: Anne Marie Sørensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vested M, Sorensen AM, Bjerring C, Christensen RE, Dinesen F, Vang M, Gilvanoff A, Hansen TE, Nielsen T, Rasmussen LS. A blinded randomized study comparing intubating conditions after either rocuronium 0.6 mg.kg-1 or remifentanil 2 microg.kg-1 in elderly patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1367-1373. doi: 10.1111/aas.13957. Epub 2021 Sep 5.