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

Phase 1

• 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: 21.1Level: LLTClassification code 10002321Term: AnesthesiaSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-004343-76-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

- Neuromuscular disease
- Known allergy to rocuronium
- Prone position

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified