Neuromuscular BlockadeROSANNANCT02054468
Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol Anesthesia
A study testing Single-Shot Propofol, 30min infusion Propofol and Remifentanil infusion in people with Neuromuscular Blockade and Anesthesia, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Anesthesia
- What is being tested?
- Single-Shot Propofol, 30min infusion Propofol and Remifentanil infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Feb 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
- Patients scheduled for a low risk-surgical procedure under general anesthesia
- Patients ASA physical status I-III
- Patients older than 18years
- Patients having given informed consent to the study
Who cannot join
- Patients who decline to give informed consent to the study
- Known or suspected allergy towards anesthetics or rocuronium
- Pregnant and breastfeeding women
- Known or suspected neuromuscular disease
- Burn injury prior to the investigation
- Anatomic and functional malformations with expected difficult intubation
Show all 9Show fewer
- Anorexia, Bulimia nervosa, Malnutrition
- Heart failure
- Use of drugs that interfere with muscle relaxant
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol
This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.
Read the detailed description
Neuromuscular blocking agents are worldwide used as a standard component of a modern balanced anesthesia regime. They are administered to facilitate tracheal intubation, reduce laryngeal trauma and optimize surgical conditions. The dose usually recommended to facilitate tracheal intubation approximates at least two times the drug´s effective dose ED-95 (the dose required for a 95% effect) depending on the choice of the neuromuscular blocking agent. This overdose is administered to induce a very deep paralysis with a fast onset of action providing clinically acceptable intubating conditions. Moreover, our clinical experience has shown that the dose-relationship of a neuromuscular blocking agents estimated during steady-state anesthesia does not necessarily correlate with the dose-response curve of the same drug during anesthetic induction. Therefore, a discrepancy between the applied dose and the clinical outcome measure, the intubating conditions, becomes apparent. This might be related to effects of the co-administered anesthetics at the neuromuscular junction. While inhaled anesthetics augment the paralyzing effects of non-depolarizering muscle relaxants in a dose-dependent fashion and depend on the duration of anesthesia, little is known about the interactions of the intravenous anesthetic propofol with the non-depolarizing blocking agent rocuronium. We hypothesize that the intravenous administration of propofol also influences the potency of rocuronium dependant on the duration of its application.
This study, therefore, is designed to determine the dose-response relationship of rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting. The primary endpoints are the ED-50s and ED-95s of rocuronium during anesthetic induction with a single-shot propofol and after 30minutes of steady-state propofol anesthesia. The secondary endpoints are the slopes and the intercepts of the respective dose-response-curves, the onset and duration of muscle paralysis and the recovery from neuromuscular blockade.
Materials \& Methods
We will investigate patients scheduled for elective low-risk surgical procedures under general anesthesia. Patients will be allocated to two experimental groups. After neuromuscular monitoring is established under remifentanil infusion, patients of the group "Induction" will receive a single-shot propofol followed by injection of rocuronium and endotracheal intubation. Patients of the group "Maintenance" will be anaesthetized with an induction dose of propofol followed by 30 minutes of total intravenous anesthesia (TIVA: propofol/ remifentanil) before rocuronium is administered. Airway will be managed using a laryngeal mask or tracheal intubation.
During surgery, anesthesia will be maintained with TIVA. Onset and duration of neuromuscular blockade and spontaneous recovery will be monitored with electromyography.
Postoperatively, patients will be monitored for 60 minutes in our post-anesthesia care unit.
- Conditions
- Neuromuscular Blockade, Anesthesia
- Being tested
- Single-Shot Propofol, 30min infusion Propofol, Remifentanil infusion, Rocuronium (0.07mg/kg/body mass), Rocuronium (0.1mg/kg/body mass)
- Keywords
- Muscle relaxant, Rocuronium, TIVA, Propofol
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Shot PropofolDrug
Also called 2,6-Diisopropylphenol
Single-shot propofol induction dose (1.5-2.5mg/kg body mass)
30min infusion PropofolDrug
Also called 2,6-Diisopropylphenol
30min of propofol infusion (4-6mg/kg/h)
Remifentanil infusionDrug
Also called Ultiva®
Remifentanil infusion (0.1-0.2µg/kg/min)
Rocuronium (0.07mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.07mg/kg/body mass)
Rocuronium (0.1mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.1mg/kg/body mass)
Rocuronium (0.15mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.15mg/kg/body mass)
Rocuronium (0.2mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.2mg/kg/body mass)
Rocuronium (0.3mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.3mg/kg/body mass)
Rocuronium (0.45mg/kg/body mass)Drug
Also called Esmeron
Rocuronium (0.45mg/kg/body mass)
| Study group | Role | What they receive |
|---|---|---|
| Single-shot-Propofol & Remifentanil | Active comparator | Induction group: A single-shot propofol induction dose with remifentanil infusion followed by injection of rocuronium (for doses, please see interventions). Airway: tracheal intubation Receives: Drug: Single-Shot Propofol; Drug: Remifentanil infusion; Drug: Rocuronium (0.07mg/kg/body mass); Drug: Rocuronium (0.1mg/kg/body mass); Drug: Rocuronium (0.15mg/kg/body mass); Drug: Rocuronium (0.2mg/kg/body mass); Drug: Rocuronium (0.3mg/kg/body mass); Drug: Rocuronium (0.45mg/kg/body mass) |
| 30min infusion Propofol & Remifentanil | Experimental | Maintenance group: 30min of total intravenous anesthesia (TIVA) with propofol and remifentanil before rocuronium (for doses, please see interventions) is administered. Airway: tracheal intubation/laryngeal mask Receives: Drug: 30min infusion Propofol; Drug: Remifentanil infusion; Drug: Rocuronium (0.07mg/kg/body mass); Drug: Rocuronium (0.1mg/kg/body mass); Drug: Rocuronium (0.15mg/kg/body mass); Drug: Rocuronium (0.2mg/kg/body mass); Drug: Rocuronium (0.3mg/kg/body mass); Drug: Rocuronium (0.45mg/kg/body mass) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED-50 of rocuronium
The primary outcome measure is the 1) ED-50 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia
Measured: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
ED-95 of rocuronium
The primary outcome measure is 2) the ED-95 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia
Measured: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
Secondary outcomes (1)
Pharmacodynamics of rocuronium (composite outcome measure)
The secondary outcome measures are the slopes and the intercepts of the dose-response-curves for rocuronium, the onset and duration of muscle paralysis and the recovery from neuromuscular blockade.
Measured: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manfred Blobner, M.D., Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054468
- Sponsor's protocol ID
- ROSANNA
- Acronym
- ROSANNA
- Status last verified
- May 2014
- First submitted
- 30 Jan 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Naguib M, Seraj M, Abdulrazik E. Pipecuronium-induced neuromuscular blockade during nitrous oxide-fentanyl, enflurane, isoflurane, and halothane anesthesia in surgical patients. Anesth Analg. 1992 Aug;75(2):193-7. doi: 10.1213/00000539-199208000-00007.
PubMed 1321569Viby-Mogensen J, Jorgensen BC, Ording H. Residual curarization in the recovery room. Anesthesiology. 1979 Jun;50(6):539-41. doi: 10.1097/00000542-197906000-00014. No abstract available.
PubMed 156513Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
PubMed 12717123Eikermann M, Blobner M, Groeben H, Rex C, Grote T, Neuhauser M, Beiderlinden M, Peters J. Postoperative upper airway obstruction after recovery of the train of four ratio of the adductor pollicis muscle from neuromuscular blockade. Anesth Analg. 2006 Mar;102(3):937-42. doi: 10.1213/01.ane.0000195233.80166.14.
PubMed 16492855Hemmerling TM, Le N, Decarie P, Cousineau J, Bracco D. Total intravenous anesthesia with propofol augments the potency of mivacurium. Can J Anaesth. 2008 Jun;55(6):351-7. doi: 10.1007/BF03021490.
PubMed 18566198Robertson EN, Fragen RJ, Booij LH, van Egmond J, Crul JF. Some effects of diisopropyl phenol (ICI 35 868) on the pharmacodynamics of atracurium and vecuronium in anaesthetized man. Br J Anaesth. 1983 Aug;55(8):723-8. doi: 10.1093/bja/55.8.723.
PubMed 6136286
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol
- ClinicalTrials.gov ID
- NCT02054468
- Acronym / sponsor ID
- ROSANNA / ROSANNA
- Conditions
- Neuromuscular Blockade, Anesthesia
- Keywords
- Muscle relaxant, Rocuronium, TIVA, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Feb 2014 (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.
This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.
Detailed description
Neuromuscular blocking agents are worldwide used as a standard component of a modern balanced anesthesia regime. They are administered to facilitate tracheal intubation, reduce laryngeal trauma and optimize surgical conditions. The dose usually recommended to facilitate tracheal intubation approximates at least two times the drug´s effective dose ED-95 (the dose required for a 95% effect) depending on the choice of the neuromuscular blocking agent. This overdose is administered to induce a very deep paralysis with a fast onset of action providing clinically acceptable intubating conditions. Moreover, our clinical experience has shown that the dose-relationship of a neuromuscular blocking agents estimated during steady-state anesthesia does not necessarily correlate with the dose-response curve of the same drug during anesthetic induction. Therefore, a discrepancy between the applied dose and the clinical outcome measure, the intubating conditions, becomes apparent. This might be related to effects of the co-administered anesthetics at the neuromuscular junction. While inhaled anesthetics augment the paralyzing effects of non-depolarizering muscle relaxants in a dose-dependent fashion and depend on the duration of anesthesia, little is known about the interactions of the intravenous anesthetic propofol with the non-depolarizing blocking agent rocuronium. We hypothesize that the intravenous administration of propofol also influences the potency of rocuronium dependant on the duration of its application.
This study, therefore, is designed to determine the dose-response relationship of rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting. The primary endpoints are the ED-50s and ED-95s of rocuronium during anesthetic induction with a single-shot propofol and after 30minutes of steady-state propofol anesthesia. The secondary endpoints are the slopes and the intercepts of the respective dose-response-curves, the onset and duration of muscle paralysis and the recovery from neuromuscular blockade.
Materials \& Methods
We will investigate patients scheduled for elective low-risk surgical procedures under general anesthesia. Patients will be allocated to two experimental groups. After neuromuscular monitoring is established under remifentanil infusion, patients of the group "Induction" will receive a single-shot propofol followed by injection of rocuronium and endotracheal intubation. Patients of the group "Maintenance" will be anaesthetized with an induction dose of propofol followed by 30 minutes of total intravenous anesthesia (TIVA: propofol/ remifentanil) before rocuronium is administered. Airway will be managed using a laryngeal mask or tracheal intubation.
During surgery, anesthesia will be maintained with TIVA. Onset and duration of neuromuscular blockade and spontaneous recovery will be monitored with electromyography.
Postoperatively, patients will be monitored for 60 minutes in our post-anesthesia care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-shot-Propofol & Remifentanil | Active comparator | Drug: Single-Shot Propofol, Drug: Remifentanil infusion, Drug: Rocuronium (0.07mg/kg/body mass), Drug: Rocuronium (0.1mg/kg/body mass), Drug: Rocuronium (0.15mg/kg/body mass), Drug: Rocuronium (0.2mg/kg/body mass), Drug: Rocuronium (0.3mg/kg/body mass), Drug: Rocuronium (0.45mg/kg/body mass)Induction group: A single-shot propofol induction dose with remifentanil infusion followed by injection of rocuronium (for doses, please see interventions). Airway: tracheal intubation |
| 30min infusion Propofol & Remifentanil | Experimental | Drug: 30min infusion Propofol, Drug: Remifentanil infusion, Drug: Rocuronium (0.07mg/kg/body mass), Drug: Rocuronium (0.1mg/kg/body mass), Drug: Rocuronium (0.15mg/kg/body mass), Drug: Rocuronium (0.2mg/kg/body mass), Drug: Rocuronium (0.3mg/kg/body mass), Drug: Rocuronium (0.45mg/kg/body mass)Maintenance group: 30min of total intravenous anesthesia (TIVA) with propofol and remifentanil before rocuronium (for doses, please see interventions) is administered. Airway: tracheal intubation/laryngeal mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for a low risk-surgical procedure under general anesthesia
- Patients ASA physical status I-III
- Patients older than 18years
- Patients having given informed consent to the study
Key exclusion criteria (9 listed)
- Patients who decline to give informed consent to the study
- Known or suspected allergy towards anesthetics or rocuronium
- Pregnant and breastfeeding women
- Known or suspected neuromuscular disease
- Burn injury prior to the investigation
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 |
|---|---|---|
| Single-Shot PropofolAlso: 2,6-DiisopropylphenolSingle-shot propofol induction dose (1.5-2.5mg/kg body mass) | Drug | Single-shot-Propofol & Remifentanil |
| 30min infusion PropofolAlso: 2,6-Diisopropylphenol30min of propofol infusion (4-6mg/kg/h) | Drug | 30min infusion Propofol & Remifentanil |
| Remifentanil infusionAlso: Ultiva®Remifentanil infusion (0.1-0.2µg/kg/min) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.07mg/kg/body mass)Also: EsmeronRocuronium (0.07mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.1mg/kg/body mass)Also: EsmeronRocuronium (0.1mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.15mg/kg/body mass)Also: EsmeronRocuronium (0.15mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.2mg/kg/body mass)Also: EsmeronRocuronium (0.2mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.3mg/kg/body mass)Also: EsmeronRocuronium (0.3mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
| Rocuronium (0.45mg/kg/body mass)Also: EsmeronRocuronium (0.45mg/kg/body mass) | Drug | 30min infusion Propofol & Remifentanil, Single-shot-Propofol & Remifentanil |
Primary outcome
ED-50 of rocuronium
Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
The primary outcome measure is the 1) ED-50 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia
ED-95 of rocuronium
Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
The primary outcome measure is 2) the ED-95 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia
1 secondary outcome
Pharmacodynamics of rocuronium (composite outcome measure)
Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min
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 8 May 2014.
- Background: PubMed 1321569Naguib M, Seraj M, Abdulrazik E. Pipecuronium-induced neuromuscular blockade during nitrous oxide-fentanyl, enflurane, isoflurane, and halothane anesthesia in surgical patients. Anesth Analg. 1992 Aug;75(2):193-7. doi: 10.1213/00000539-199208000-00007.
- Background: PubMed 156513Viby-Mogensen J, Jorgensen BC, Ording H. Residual curarization in the recovery room. Anesthesiology. 1979 Jun;50(6):539-41. doi: 10.1097/00000542-197906000-00014. No abstract available.
- Background: PubMed 12717123Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
- Background: PubMed 16492855Eikermann M, Blobner M, Groeben H, Rex C, Grote T, Neuhauser M, Beiderlinden M, Peters J. Postoperative upper airway obstruction after recovery of the train of four ratio of the adductor pollicis muscle from neuromuscular blockade. Anesth Analg. 2006 Mar;102(3):937-42. doi: 10.1213/01.ane.0000195233.80166.14.
- Background: PubMed 18566198Hemmerling TM, Le N, Decarie P, Cousineau J, Bracco D. Total intravenous anesthesia with propofol augments the potency of mivacurium. Can J Anaesth. 2008 Jun;55(6):351-7. doi: 10.1007/BF03021490.
- Background: PubMed 6136286Robertson EN, Fragen RJ, Booij LH, van Egmond J, Crul JF. Some effects of diisopropyl phenol (ICI 35 868) on the pharmacodynamics of atracurium and vecuronium in anaesthetized man. Br J Anaesth. 1983 Aug;55(8):723-8. doi: 10.1093/bja/55.8.723.
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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.
Manfred Blobner, M.D. principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, 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 Single-Shot Propofol, 30min infusion Propofol and Remifentanil infusion in people with Neuromuscular Blockade and Anesthesia, run by Technical University of Munich 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 4 inclusion and 9 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 8 May 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?
ED-50 of rocuronium (time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min). The study lists 2 primary outcomes in all. 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 NCT02054468, which also lists 6 linked publications.
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 8 May 2014.