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

NCT04287426 | Completed Phase 4 DMC

• 2 other identifiers: H-190703432019-004121-25
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuromuscular Blockade; Intubation Complication; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Evaluation of intubating conditions ad modum Fuchs-Buder et al

  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.

  2 minutes after start of administration of trial medication

Secondary Outcomes (3)

• Subjective side effects of laryngoscopy

  24 hours postoperatively and 3 days postoperatively

• Dose of ephedrine or dose of metaoxedrine administered

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

• Intubating conditions according to IDS

  2 minutes after start of administration of trial medication

Study Arms (2)

Group receiving rocuronium at induction

ACTIVE COMPARATOR

Rocuronium 0,6 mg/kg at induction

Drug: Rocuronium 0.6 mg/kg

Group receiving remifentanil at induction

ACTIVE COMPARATOR

Remifentanil 2 μg/kg at induction

Drug: Remifentanil 2 µg/kg

Interventions

Rocuronium 0.6 mg/kg DRUG

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

Group receiving rocuronium at induction

Remifentanil 2 µg/kg DRUG

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

Group receiving remifentanil at induction

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Rigshospitalet, Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34310692 DERIVED

MeSH Terms

Interventions

Rocuronium; Remifentanil

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matias Vested, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Anne Marie Sørensen, MD, PhD

  Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 27, 2020
• Study Start: March 11, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 13, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)