Elective Surgery Clinical Trial
Official title:
An Observational Study of Rocuronium 0.6 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubation Conditions in Younger (18 - 40 Years) and Elderly Patients (> 80 Years)
NCT number | NCT03857750 |
Other study ID # | H-18063017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 27, 2019 |
Est. completion date | October 8, 2019 |
Verified date | May 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | October 8, 2019 |
Est. primary completion date | October 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Known allergy to rocuronium - Neuromuscular disease that may interfere with neuromuscular data - Indication for rapid sequence induction |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Comparing Intubating Conditions in the Two Groups | 90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS). Easy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as >5 |
Day 0, after induction of anesthesia | |
Secondary | Duration of Action | Time from end of rocuronium injection to TOF ratio >0.9. When the ratio between the first and last stimulation in TOF is above 90 %. | Day 0, after induction of anesthesia |
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