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

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Intubation Complication; Neuromuscular Blockade; Anesthesia

Treatments: Drug: Remifentanil 2 µg/kg; Drug: Rocuronium 0.6 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT04287426

2019-004121-25 (EudraCT Number)

H-19070343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

Group receiving rocuronium at induction

Active Comparator group

Description:

Rocuronium 0,6 mg/kg at induction

Treatment:

Drug: Rocuronium 0.6 mg/kg

Group receiving remifentanil at induction

Active Comparator group

Description:

Remifentanil 2 μg/kg at induction

Treatment:

Drug: Remifentanil 2 µg/kg