AnesthesiaPhase 4Broncho-SRNCT01579864
Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia
A Phase 4 study testing succinylcholine and rocuronium in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- succinylcholine and rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jun 2015
- Phase
- Phase 4
- 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
- patients scheduled for an interventional rigid bronchoscopy under general anesthesia
Who cannot join
- pregnant woman or woman of childbearing age,
- morbid obesity,
- drug allergy,contra-indication to succinylcholine, rocuronium, sugammadex, propofol, remifentanil,
- history of central neurological or brain damage,
- psychotropic treatment,
- pacemaker,
- renal failure,
- disease of the neuromuscular junction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure
Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.
- Conditions
- Anesthesia
- Being tested
- succinylcholine, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
succinylcholineDrug
Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue
rocuroniumDrug
rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary
| Study group | Role | What they receive |
|---|---|---|
| succinylcholine | Active comparator | Succinylcholine 1 mg/kg and a second dose if necessary. Receives: Drug: succinylcholine |
| Rocuronium | Experimental | rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary Receives: Drug: rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of quality of the surgical procedure
The quality of the surgical procedure is evaluated by the surgeon (composite score) who is unaware of the neuromuscular agent used (see Fuchs-Buder et al. Acta Anaesthesiol Scand 2007;51(7):789-808)
Measured: one day
Secondary outcomes (1)
Score of quality of anesthesia
The quality of anesthesia is evaluated by the anesthesist in charge on a scale 0-30 (0-10 for the induction ; 0-10 for maintenance; 0-10 for recovery)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579864
- Sponsor's protocol ID
- 2011/05
- Other IDs
- 2011-000370-59
- Acronym
- Broncho-SR
- Status last verified
- Nov 2016
- First submitted
- 4 Jan 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure
- ClinicalTrials.gov ID
- NCT01579864
- Acronym / sponsor ID
- Broncho-SR / 2011/05
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21)
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Apr 2012 (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.
Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| succinylcholine | Active comparator | Drug: succinylcholineSuccinylcholine 1 mg/kg and a second dose if necessary. |
| Rocuronium | Experimental | Drug: rocuroniumrocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for an interventional rigid bronchoscopy under general anesthesia
Key exclusion criteria (8 listed)
- pregnant woman or woman of childbearing age,
- morbid obesity,
- drug allergy,contra-indication to succinylcholine, rocuronium, sugammadex, propofol, remifentanil,
- history of central neurological or brain damage,
- psychotropic treatment,
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 |
|---|---|---|
| succinylcholineSuccinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue | Drug | succinylcholine |
| rocuroniumrocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary | Drug | Rocuronium |
Primary outcome
Score of quality of the surgical procedure
Time frame: one day
The quality of the surgical procedure is evaluated by the surgeon (composite score) who is unaware of the neuromuscular agent used (see Fuchs-Buder et al. Acta Anaesthesiol Scand 2007;51(7):789-808)
1 secondary outcome
Score of quality of anesthesia
Time frame: one day
Results and safety
The study was stopped early (reason given: recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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.
Morgan Le Guen, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing succinylcholine and rocuronium in people with Anesthesia, run by Hopital Foch at 1 site in France.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Nov 2016. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recent publication (Ghezel-Ahmadi. Thorac Cardiovasc Surg. 2014 Nov 21)). 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?
Score of quality of the surgical procedure (time frame: one day). 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 3 Nov 2016.