An examination of which type of medicine (rocuronium or remifentanil) is better concerning placement of a tube in trachea in elderly patients under going anesthesia

A single-blinded multicenter randomized study comparing intubating conditions after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in elderly patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004121-25-DK

Enrollment

Registered

2019-11-02

Start date

2019-12-17

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 21.1 Level: LLT Classification code 10002323 Term: Anesthesia general System Organ Class: 100000004865

Interventions

Trade Name: Rocuronium "Hameln" Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ROCURONIUM CAS Number: 119302-91-9 Current Sponsor code: NMBA_ELDERLY2019ROCU_REMI Other descr

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74

Exclusion criteria

Exclusion criteria: - Neuromuscular disease - Known allergy to rocuronium, remifentanil or sugammadex

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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 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. ;Primary end point(s): The primary outcome is the occurrence of excellent intubating conditions 2 minutes after administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. ;Timepoint(s) of evaluation of this end point: It will be examined 2 minutes after bolus injection	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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 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. ;Primary end point(s): The primary outcome is the occurrence of excellent intubating conditions 2 minutes after administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. ;Timepoint(s) of evaluation of this end point: It will be examined 2 minutes after bolus injection

—

Secondary

Measure	Time frame
Secondary end point(s): Subjective side effects of laryngoscope Amount of epinephrine or metaoxedrine administered Intubation Difficulty Score ;Timepoint(s) of evaluation of this end point: During the operation	—

Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesia

Rigshospitalet

lars.simon.rasmussen.01@regionh.dk4535458043

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026