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

NCT ID: NCT04287426

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2020-12-13

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.

Conditions

Neuromuscular Blockade; Intubation Complication; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group receiving rocuronium at induction

Rocuronium 0,6 mg/kg at induction

Group Type: ACTIVE_COMPARATOR

Rocuronium 0.6 mg/kg

Intervention Type: DRUG

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

Group receiving remifentanil at induction

Remifentanil 2 μg/kg at induction

Group Type: ACTIVE_COMPARATOR

Remifentanil 2 µg/kg

Intervention Type: DRUG

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

Interventions

Rocuronium 0.6 mg/kg

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

Intervention Type: DRUG

Remifentanil 2 µg/kg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Matias Vested

Principal Investigator, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matias Vested, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark

Anne Marie Sørensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Rigshospitalet, Glostrup

Glostrup Municipality, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34310692 (View on PubMed)

Other Identifiers

2019-004121-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-19070343

Identifier Type: -

Identifier Source: org_study_id