Intubating ConditionsNCT01996358
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
A study testing Succinylcholine, Rocuronium 0,3 and Rocuronium 0,6 in people with Intubating Conditions and Postoperative Myalgia, 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 more modern alternative is the application aof rocuronium, reversed by sugammadex. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubating Conditions, Postoperative Myalgia, Patient Satisfaction
- What is being tested?
- Succinylcholine, Rocuronium 0,3 and Rocuronium 0,6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Dec 2017
- 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
- Healthy volunteers accepted
- 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
Official title: Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.
- Being tested
- Succinylcholine, Rocuronium 0,3, Rocuronium 0,6
- Keywords
- Succinylcholine, Rocuronium, Rigid Bronchoscopy
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
Rocuronium 0,3Drug
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Rocuronium 0,6Drug
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
| Study group | Role | What they receive |
|---|---|---|
| Succinylcholine | Active comparator | Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy Receives: Drug: Succinylcholine |
| Rocuronium 0,3 | Active comparator | Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied. Receives: Drug: Rocuronium 0,3 |
| Rocuronium 0,6 | Active comparator | Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied. Receives: Drug: Rocuronium 0,6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubating Condition
The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing
Measured: after induction of general anaesthesia (after 3-5 minutes)
Secondary outcomes (1)
Postoperative Myalgia
The severity of POM is measured by using a four-point-scale:
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startAug 2015
- Primary completionDec 2017 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prof. Grietje Beck, Dr. Horst Schmidt Klinik GmbH
- Investigators
- Grietje Beck, Prof, Study chair, Dr. Horst Schmidt Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996358
- Sponsor's protocol ID
- HSK004
- Status last verified
- Apr 2017
- First submitted
- 22 Nov 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study
- ClinicalTrials.gov ID
- NCT01996358
- Acronym / sponsor ID
- HSK004
- Keywords
- Succinylcholine, Rocuronium, Rigid Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 27 Nov 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 more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Succinylcholine | Active comparator | Drug: SuccinylcholineSuccinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy |
| Rocuronium 0,3 | Active comparator | Drug: Rocuronium 0,3Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied. |
| Rocuronium 0,6 | Active comparator | Drug: Rocuronium 0,6Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| SuccinylcholineAnaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group. | Drug | Succinylcholine |
| Rocuronium 0,3General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group. | Drug | Rocuronium 0,3 |
| Rocuronium 0,6General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group. | Drug | Rocuronium 0,6 |
Primary outcome
Intubating Condition
Time frame: after induction of general anaesthesia (after 3-5 minutes)
The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing
1 secondary outcome
Postoperative Myalgia
Time frame: 72 hours after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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
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, Rocuronium 0,3 and Rocuronium 0,6 in people with Intubating Conditions and Postoperative Myalgia, 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: paused, as of the sponsor's last update on 4 Apr 2017. 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?
Results are not available in the source record.
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 4 Apr 2017.