An examination of how fast and long rocuronium works in elderly patients when comparing a high and low dose.

A single-blinded multicenter randomized interventional study of rocuronium 0.3 mg/kg, and 0.9 mg/kg comparing onset time, duration of action and effect on intubating conditions in elderly patients (= 80 years).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004343-76-DK

Enrollment

Registered

2019-11-11

Start date

2020-02-27

Completion date

Unknown

Last updated

2021-06-07

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 onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age = 80 years. MedDRA version: 21.1 Level: LLT Classification code 10002321 Term: Anesthesia System Organ Class: 100000004852

Interventions

Trade Name: Rocuronium "Hameln" Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ROCURONIUM CAS Number: 119302-91-9 Current Sponsor code: Org 25969 Other descriptive name: Non

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 80 - Scheduled to elective surgery (expected duration time of surgery > 1 hour) under general anesthesia with intubation and use of rocuronium - American Society of Anesthesiologists (ASA) physical status classification 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 40

Exclusion criteria

Exclusion criteria: - Neuromuscular disease - Known allergy to rocuronium - Prone position

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to determine the onset time after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age = 80 years.;Secondary Objective: The aim of this study is to determine the duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age = 80 years.;Primary end point(s): The primary end point is onset time, defined as the time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyograph.;Timepoint(s) of evaluation of this end point: It will be examined during induction of anesthesia	—

Measure

Time frame

Main Objective: The aim of this study is to determine the onset time after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age = 80 years.;Secondary Objective: The aim of this study is to determine the duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age = 80 years.;Primary end point(s): The primary end point is onset time, defined as the time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyograph.;Timepoint(s) of evaluation of this end point: It will be examined during induction of anesthesia

—

Secondary

Measure	Time frame
Secondary end point(s): Duration of action Intubating conditions according to Fuchs-Buder et al and 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