Intubating ConditionsNCT01902641
Muscle Relaxation for Short Procedures
A study testing Succinylcholine, Rocuronium/Sugammadex and Rocuronium in people with Intubating Conditions and Fasciculations, 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 of low-dose rocuronium, reversed by low-dose 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, Fasciculations, Postoperative Myalgia
- What is being tested?
- Succinylcholine, Rocuronium/Sugammadex and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Mar 2012
- 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 and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium 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 of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants.
- Conditions
- Intubating Conditions, Fasciculations, Postoperative Myalgia, Patient Satisfaction, Sore Throat
- Being tested
- Succinylcholine, Rocuronium/Sugammadex, Rocuronium
- Keywords
- succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures
- Medical subject headings
- Fasciculation, Patient Satisfaction, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received succinycholine according to the study group.
Rocuronium/SugammadexDrug
Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium/sugammadex according to the study group.
RocuroniumDrug
Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium according to the study group.
| Study group | Role | What they receive |
|---|---|---|
| Succinylcholine | Active comparator | Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy. Receives: Drug: Succinylcholine |
| Rocuronium/Sugammadex | Active comparator | Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.) Receives: Drug: Rocuronium/Sugammadex |
| Rocuronium | Active comparator | Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubating condition
scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing
Measured: After induction of general anaesthesia (after 3-5 minutes)
Secondary outcomes (2)
Fasciculations
Fasciculations were graded by the investigator on the following four-point scale
0 = no fasciculations
- = mild, fine fasciculations of the eyes, neck, face or fingers, without limb movement
- = moderate fasciculations occurring at more than two sites, or obvious limb movement
- = vigorous or severe, sustained and widespread fasciculations in the trunk and limbs
Measured: After application of the neuromuscular blocking agent (after 3-5 min)
Postoperative Myalgia (POM)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
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 Kliniken Wiesbaden Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902641
- Sponsor's protocol ID
- HSK001
- Other IDs
- 2011_333N-MA
- Status last verified
- Jul 2013
- First submitted
- 9 Jul 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study
- ClinicalTrials.gov ID
- NCT01902641
- Acronym / sponsor ID
- HSK001
- Conditions
- Intubating Conditions, Fasciculations, Postoperative Myalgia, Patient Satisfaction, Sore Throat
- Keywords
- succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Jul 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 of low-dose rocuronium, reversed by low-dose 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
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Succinylcholine | Active comparator | Drug: SuccinylcholinePatient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy. |
| Rocuronium/Sugammadex | Active comparator | Drug: Rocuronium/SugammadexPatient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.) |
| Rocuronium | Active comparator | Drug: RocuroniumPatients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy. |
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 was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received succinycholine according to the study group. | Drug | Succinylcholine |
| Rocuronium/SugammadexAnaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium/sugammadex according to the study group. | Drug | Rocuronium/Sugammadex |
| RocuroniumAnaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium according to the study group. | Drug | Rocuronium |
Primary outcome
Intubating condition
Time frame: After induction of general anaesthesia (after 3-5 minutes)
scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing
2 secondary outcomes
Fasciculations
Time frame: After application of the neuromuscular blocking agent (after 3-5 min)
Postoperative Myalgia (POM)
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 18 Jul 2013.
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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 Kliniken 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, Rocuronium/Sugammadex and Rocuronium in people with Intubating Conditions and Fasciculations, 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 18 Jul 2013. 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 18 Jul 2013.