Intubating ConditionsNCT01966484
Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy
A study testing Succinylcholine and Mivacurium in people with Intubating Conditions and Performance With Respiratory Exercise Device, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
Trial summary
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with neostigmine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubating Conditions, Performance With Respiratory Exercise Device, Postoperative Myalgia
- What is being tested?
- Succinylcholine and Mivacurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Who cannot join
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with neostigmine. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), patient satisfaction and the postoperative performance with respiration exercise device for these two muscle relaxants.
- Conditions
- Intubating Conditions, Performance With Respiratory Exercise Device, Postoperative Myalgia
- Being tested
- Succinylcholine, Mivacurium
- Keywords
- Succinylcholine, Mivacurium, Rigid Bronchoscopy, Intubating conditions, Short Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
Also called Mivacurium, Rigid Bronchoscopy
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
MivacuriumDrug
Also called Succinylcholine, Rigid Bronchoscopy
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
| Study group | Role | What they receive |
|---|---|---|
| Succinylcholine | Active comparator | Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy. Receives: Drug: Succinylcholine |
| Mivacurium | Active comparator | Patients receive mivacurium (0,08mg/kg) as a muscle relaxant after induction of general anaesthesia for rigid bronchoscopy. At the end of the procedure and a twitch of 25% mivacurium was reversed with neostigmine (50 microg/kg) and atropin (10 microg/kg) Receives: Drug: Mivacurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubating condition
For measuring the intubation conditions the scoring system proposed for Good clinical Research Practice using the following variables is used: conditions of inserting the rigid bronchoscope, vocal cord position and coughing
Measured: After induction of general anaesthesia (after 3-5 minutes)
Secondary outcomes (2)
Postoperative Myalgia
The severity of POM was measured using a four point scale:
0=no myalgia
- minor pain limited to one area of the body
- muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy
- generalized, severe or incapacitating discomfort
Measured: 72 hours after intervention
postintervention performance with a expiration exercise device
The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.
Measured: 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubating ConditionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grietje Beck, Prof, Study chair, Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966484
- Sponsor's protocol ID
- HSK003
- Status last verified
- Jul 2014
- First submitted
- 17 Oct 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy
- ClinicalTrials.gov ID
- NCT01966484
- Acronym / sponsor ID
- HSK003
- Conditions
- Intubating Conditions, Performance With Respiratory Exercise Device, Postoperative Myalgia
- Keywords
- Succinylcholine, Mivacurium, Rigid Bronchoscopy, Intubating conditions, Short Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 21 Oct 2013 (estimated)
- 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.
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with neostigmine. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), patient satisfaction and the postoperative performance with respiration exercise device for these two muscle relaxants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Succinylcholine | Active comparator | Drug: SuccinylcholinePatient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy. |
| Mivacurium | Active comparator | Drug: MivacuriumPatients receive mivacurium (0,08mg/kg) as a muscle relaxant after induction of general anaesthesia for rigid bronchoscopy. At the end of the procedure and a twitch of 25% mivacurium was reversed with neostigmine (50 microg/kg) and atropin (10 microg/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Key exclusion criteria (5 listed)
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
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 |
|---|---|---|
| SuccinylcholineAlso: Mivacurium, Rigid BronchoscopyAnaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group. | Drug | Succinylcholine |
| MivacuriumAlso: Succinylcholine, Rigid BronchoscopyAnaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group. | Drug | Mivacurium |
Primary outcome
Intubating condition
Time frame: After induction of general anaesthesia (after 3-5 minutes)
For measuring the intubation conditions the scoring system proposed for Good clinical Research Practice using the following variables is used: conditions of inserting the rigid bronchoscope, vocal cord position and coughing
2 secondary outcomes
Postoperative Myalgia
Time frame: 72 hours after intervention
postintervention performance with a expiration exercise device
Time frame: 72 hours after intervention
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 30 Jul 2014.
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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.
Grietje Beck, Prof study chair
Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Succinylcholine and Mivacurium in people with Intubating Conditions and Performance With Respiratory Exercise Device, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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 2 inclusion and 5 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 30 Jul 2014. 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 Germany. 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?
Intubating condition (time frame: After induction of general anaesthesia (after 3-5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2014.