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

NCT04287426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-12-22

No results posted yet for this study

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

Interventions

DRUG

Rocuronium 0.6 mg/kg

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

DRUG

Remifentanil 2 µg/kg

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Matias Vested, MD, PhD · Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark

  • Anne Marie Sørensen, MD, PhD · Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2020-12-10
Completion
2020-12-13

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287426 on ClinicalTrials.gov