NCT03857750

Brief Summary

The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anaestheasia within the next decades. During anaesthesia NMBAs are used to facilitate tracheal intubation, from former studies it is reported that elderly patients are more sensitive towards muscle relaxants. It is unknown if there are differences in onset times of NMBAs between younger patients and elderly. The aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patiens \>80 years. The hypothesis of this study is that rocuronium administered in elderly patients (\>80 years) has a longer onset time compared to younger patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

February 25, 2019

Results QC Date

January 27, 2020

Last Update Submit

May 18, 2020

Conditions

Elective Surgery

Outcome Measures

Primary Outcomes (1)

  • Onset Time

    The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography. The ulnar nerve was stimulated during the monitoring.

    Day 0, after induction of anesthesia

Secondary Outcomes (2)

  • Comparing Intubating Conditions in the Two Groups

    Day 0, after induction of anesthesia

  • Duration of Action

    Day 0, after induction of anesthesia

Study Arms (2)

Elderly (>80 years)

Patients planned for elective surgery above 80 years

Drug: Rocuronium

Younger (18-40 years)

Patients planned for elective surgery between 18-40 years

Drug: Rocuronium

Interventions

RocuroniumDRUG

0.6 mg/kg

Also known as: Rocuronium 0.6 mg/kg
Elderly (>80 years)Younger (18-40 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

32 patients Group young: 16 patients age between 18-40 years receiving rocuronium 0.6 mg/kg Group elderly: 16 patients age \>80 years receiving rocuronium 0.6 mg/kg

You may qualify if:

  • Patients \> 18 years old
  • Informed consent
  • Scheduled for elective surgery (\>1 hour) under general anaesthesia with intubation and use of rocuronium.
  • American Society of Anaesthesiologists (ASA) physical status classification I to III
  • Can read and understand Danish

You may not qualify if:

  • Known allergy to rocuronium
  • Neuromuscular disease that may interfere with neuromuscular data
  • Indication for rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Wadland SS, Rasmussen LS, Vested M. Shortened time to neuromuscular recovery with lower doses of rocuronium in elderly patients. Dan Med J. 2024 May 13;71(6):A09230578. doi: 10.61409/A09230578.

    PMID: 38847412DERIVED

  • Bjerring C, Vested M, Arleth T, Eriksen K, Albrechtsen C, Rasmussen LS. Onset time and duration of action of rocuronium 0.6 mg/kg in patients above 80 years of age: A comparison with young adults. Acta Anaesthesiol Scand. 2020 Sep;64(8):1082-1088. doi: 10.1111/aas.13645. Epub 2020 Jun 18.

    PMID: 32462665DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Matias Vested
Organization
Rigshospitalet
matiasvested@gmail.com
+4524464955

Study Officials

  • Matias Vested, MD, Phd

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor, PhD

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 28, 2019

Study Start

March 27, 2019

Primary Completion

October 8, 2019

Study Completion

October 8, 2019

Last Updated

June 2, 2020

Results First Posted

June 2, 2020

Record last verified: 2020-05

Locations

DK(1)