Onset Time of CisatracuriumNCT04921735
An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.
An observational study of Onset Time of Cisatracurium and Duration of Action of Cisatracurium, run by Matias Vested at 1 site in Denmark.
Trial summary
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Onset Time of Cisatracurium, Duration of Action of Cisatracurium, Intubation Conditions
- What is being tested?
- Cisatracurium
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jul 2021to 19 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery
Who may be able to join
- Patients ≥ 80 or ≥18 - ≤40 years of age
- Informed consent
- Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia > 1 hour) with intubation and use of cisatracurium
- American Society of Anaesthesiologists (ASA) physical status classification I to III
- Can read and understand Danish
Who cannot join
- Known allergy to cisatracurium
- Neuromuscular disease
- Indication for rapid sequence induction
- Surgery in the prone position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.
Read the detailed description
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (>80 years) has a longer onset time and duration of action compared to younger patients.
- Being tested
- Cisatracurium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
0.15 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower
| Study group | Role | What they receive |
|---|---|---|
| Elderly | patients aged 80 years or older Receives: Drug: Cisatracurium | |
| young | patients aged 18-40 years Receives: Drug: Cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time
the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography
Measured: within 10 minutes after administration
Secondary outcomes (5)
Duration of action
Duration of action is defined as time from start of cisatracurium injection to reappearance of TOF ratio > 0.9.
Measured: within 120 minutes after administration of cisatracurium
intubation conditions
intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.
Measured: within 10 minutes after administration of cistracurium
intubation conditions
intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.
Measured: within 10 minutes after administration of cisatracurium
Laryngeal morbidity
After 24 hours patients are asked about hoarseness and sore throat. Patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale from 0 to 10.
Measured: 24 hours after surgery
Amount of ephedrine or metaoxedrine administered
If ephedrine or metaoxedrine is administered after induction of anaesthesia and until the patient is ready for properly positioning for surgery, it will be noted in the CRF, as well as the amount administered. Changes in blood pressure or heart rate are treated according to local guidelines.
Measured: within 10 minutes after administration of cisatracurium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start5 Jul 2021
- Primary completion19 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Onset Time of CisatracuriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matias Vested
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matias Vested, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921735
- Sponsor's protocol ID
- Cisatracurium 2021
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vested M, Kristensen CM, Pape P, Vang M, Hartoft M, Hjelmdal C, Rasmussen LS. Comparison of onset time, duration of action, and intubating conditions after cisatracurium 0.15 mg/kg in young and elderly patients. BMC Anesthesiol. 2022 Nov 7;22(1):339. doi: 10.1186/s12871-022-01881-5.
PubMed 36344924
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.
- ClinicalTrials.gov ID
- NCT04921735
- Acronym / sponsor ID
- Cisatracurium 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Matias VestedUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.
Detailed description
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (>80 years) has a longer onset time and duration of action compared to younger patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Drug: Cisatracuriumpatients aged 80 years or older |
| young | – | Drug: Cisatracuriumpatients aged 18-40 years |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery
Key inclusion criteria (5 listed)
- Patients ≥ 80 or ≥18 - ≤40 years of age
- Informed consent
- Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia > 1 hour) with intubation and use of cisatracurium
- American Society of Anaesthesiologists (ASA) physical status classification I to III
- Can read and understand Danish
Key exclusion criteria (4 listed)
- Known allergy to cisatracurium
- Neuromuscular disease
- Indication for rapid sequence induction
- Surgery in the prone position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisatracurium0.15 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower | Drug | Elderly, young |
Primary outcome
Onset time
Time frame: within 10 minutes after administration
the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography
5 secondary outcomes
Duration of action
Time frame: within 120 minutes after administration of cisatracurium
intubation conditions
Time frame: within 10 minutes after administration of cistracurium
intubation conditions
Time frame: within 10 minutes after administration of cisatracurium
Laryngeal morbidity
Time frame: 24 hours after surgery
Amount of ephedrine or metaoxedrine administered
Time frame: within 10 minutes after administration of cisatracurium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 36344924Vested M, Kristensen CM, Pape P, Vang M, Hartoft M, Hjelmdal C, Rasmussen LS. Comparison of onset time, duration of action, and intubating conditions after cisatracurium 0.15 mg/kg in young and elderly patients. BMC Anesthesiol. 2022 Nov 7;22(1):339. doi: 10.1186/s12871-022-01881-5.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onset Time of Cisatracurium and Duration of Action of Cisatracurium, run by Matias Vested at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time (time frame: within 10 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.