Neuromuscular BlockadePhase 4NCT02794714

Deep vs Moderate Block: Impact on Operating Conditions & Patient Satisfaction

A Phase 4 study testing Deep neuromuscular blockade and Moderate neuromuscular blockade in people with Neuromuscular Blockade, run by Kuala Lumpur General Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study compares surgeon's satisfaction of operating conditions and patient's satisfaction following laparoscopic gynecological surgeries in two groups of patients, half of whom will receive deep neuromuscular blockade and the other half, moderate neuromuscular blockade. Read more about this study

Who is it for?: Ages 18 to 64 years, women only
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Deep neuromuscular blockade and Moderate neuromuscular blockade
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2016to Dec 2017
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 to 64 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia
requiring tracheal intubation
elective surgeries (eg. laparoscopy \& dye insufflation, bilateral tubal ligation, cystectomy, myomectomy, hysterectomy, salpingo-oophorectomy)
American Society of Anaesthesiology (ASA) I-II

Who cannot join

Anticipated difficult airway
Patients requiring rapid sequence induction
Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation
Patient with liver or renal failure (creatinine clearance <50mls/min)
Patients with a baseline heart rate <50/min
Patients with documented or suspected neuromuscular disorder

Show all 16Show fewer

Guillain - Barre syndrome
Cerebrovascular accidents with residual neurology
Parkinson's Disease
Myasthenia Gravis
Any condition making the administration of patient satisfaction questionnaire difficult/impossible
speech or hearing impairment and language barriers
Patients on fusidic acid or toremifene 24 hours before surgery
Patients on hormonal contraceptives; oral or otherwise
Patients on drugs, medical problems that may prolong or shorten the duration of rocuronium- (eg.. aminoglycosides, magnesium)
Patients with a history of allergy to rocuronium or sugammadex

About this study

Official title: Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction

Read the detailed description

Deep neuromuscular blockade in anesthesia has been shown to improve operating conditions in retroperitoneal surgeries, while there is minimal evidence regarding this method in laparoscopic gynecological procedures.The advantage of improving surgical conditions with a deep neuromuscular blockade in laparoscopic surgery may however lead to a delayed neuromuscular recovery and hence a delay in turnover of patients.

Rocuronium will be used for muscle relaxation in order to achieve the necessary depth of neuromuscular blockade. Sugammadex is a modified cyclodextrin that forms complexes with rocuronium, reducing free plasma concentrations of rocuronium and reversing its neuromuscular blocking action from any depth.

The use of rocuronium will therefore aid in achieving a deep neuromuscular blockade which the investigators postulate will improve surgical conditions and the reversal with sugammadex will ensure a rapid recovery thereafter.

Conditions: Neuromuscular Blockade
Being tested: Deep neuromuscular blockade, Moderate neuromuscular blockade
Keywords: Laparoscopic Gynecologic Surgeries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deep neuromuscular blockadeDrug
Also called Rocuronium, Esmeron
Deep neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction of anesthesia with intermittent boluses of 0.15 - 0.2 mg/kg to maintain a Post Tetanic Count (PTC) of 1-2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 4mg/kg.
Moderate neuromuscular blockadeDrug
Also called Rocuronium, Esmeron
Moderate neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction with intermittent boluses of 0.15 - 0.2 mg/kg to maintain Train of Four Count (TOFC) of 2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 2mg/kg.

Study groups in NCT02794714
Study group	Role	What they receive
deep neuromuscular blockade	Experimental	Rocuronium will be administered to achieve PTC 1-2 throughout surgery. Receives: Drug: Moderate neuromuscular blockade
moderate neuromuscular blockade	Active comparator	Rocuronium will be administered to achieve TOFC 2 throughout surgery Receives: Drug: Deep neuromuscular blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

Deep block versus Moderate block: Impact on surgical satisfaction
The surgeon will be required to score the quality of operating conditions every 15 minutes from 1st visualisation of peritoneal cavity until the removal of laparoscopes at the end of surgery.
Measured: Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score.

Secondary outcomes (3)

Deep block versus Moderate block: Patient satisfaction score
A blinded recovery nurse will administer Patient Satisfaction Questionaire
Measured: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
Deep block versus Moderate block: Pain score
A blinded recovery nurse will obtain the Pain Score using Visual Analogue Scale
Measured: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
Deep block versus Moderate block: PONV Score
A blinded recovery nurse will obtain the PONV Score using 4 point PONV scoring
Measured: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Dec 2017

First posted9 Jun 2016 (estimated)
Study startJun 2016
Primary completionDec 2017 (estimated)
Study completionDec 2017 (estimated)

Why it stopped: unresolved budget issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02794714
Sponsor's protocol ID: CVL#123
Status last verified: Oct 2018
First submitted: 19 May 2016
Last updated: 4 Oct 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Song D, Joshi GP, White PF. Fast-track eligibility after ambulatory anesthesia: a comparison of desflurane, sevoflurane, and propofol. Anesth Analg. 1998 Feb;86(2):267-73. doi: 10.1097/00000539-199802000-00009.
PubMed 9459231
Gupta A, Stierer T, Zuckerman R, Sakima N, Parker SD, Fleisher LA. Comparison of recovery profile after ambulatory anesthesia with propofol, isoflurane, sevoflurane and desflurane: a systematic review. Anesth Analg. 2004 Mar;98(3):632-41, table of contents. doi: 10.1213/01.ane.0000103187.70627.57.
PubMed 14980911
Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
PubMed 15896435
Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PubMed 24240315
Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
PubMed 24809482
Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko E. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012 Sep;67(9):991-8. doi: 10.1111/j.1365-2044.2012.07197.x. Epub 2012 Jun 14.
PubMed 22698066
Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.
PubMed 24427455
Carron M, Veronese S, Foletto M, Ori C. Sugammadex allows fast-track bariatric surgery. Obes Surg. 2013 Oct;23(10):1558-63. doi: 10.1007/s11695-013-0926-y.
PubMed 23519634
Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
PubMed 18946293
Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI Marco P. Reversal of rocuronium induced neuromuscular block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol Scand. 2013 Oct;57(9):1138-45. doi: 10.1111/aas.12155. Epub 2013 Jul 14.
PubMed 23849107
Gaszynski T, Szewczyk T, Gaszynski W. Randomized comparison of sugammadex and neostigmine for reversal of rocuronium-induced muscle relaxation in morbidly obese undergoing general anaesthesia. Br J Anaesth. 2012 Feb;108(2):236-9. doi: 10.1093/bja/aer330. Epub 2011 Oct 19.
PubMed 22012861
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Intraoperative acceleromyography monitoring reduces symptoms of muscle weakness and improves quality of recovery in the early postoperative period. Anesthesiology. 2011 Nov;115(5):946-54. doi: 10.1097/ALN.0b013e3182342840.
PubMed 21946094
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear T, Vender JS, Gray J, Landry E. Postoperative residual neuromuscular blockade is associated with impaired clinical recovery. Anesth Analg. 2013 Jul;117(1):133-41. doi: 10.1213/ANE.0b013e3182742e75. Epub 2013 Jan 21.
PubMed 23337416
Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.
PubMed 12190791
White H, Black RJ, Jones M, Mar Fan GC. Randomized comparison of two anti-emetic strategies in high-risk patients undergoing day-case gynaecological surgery. Br J Anaesth. 2007 Apr;98(4):470-6. doi: 10.1093/bja/aem001. Epub 2007 Feb 22.
PubMed 17317757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Deep Neuromuscular Block and Moderate Neuromuscular Block in Patients Undergoing Laparoscopic Gynaecological Surgeries: Impact on Surgical Satisfaction of Operating Conditions and Patient Satisfaction
ClinicalTrials.gov ID: NCT02794714
Acronym / sponsor ID: CVL#123
Conditions: Neuromuscular Blockade
Keywords: Laparoscopic Gynecologic Surgeries
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: unresolved budget issues
Enrolment: 0 participants (actual)
Lead sponsor: Kuala Lumpur General HospitalOther government
Collaborators: Merck Sharp & Dohme LLC
Study start: Jun 2016
Primary completion: Dec 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 9 Jun 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
deep neuromuscular blockade	Experimental	Drug: Moderate neuromuscular blockadeRocuronium will be administered to achieve PTC 1-2 throughout surgery.
moderate neuromuscular blockade	Active comparator	Drug: Deep neuromuscular blockadeRocuronium will be administered to achieve TOFC 2 throughout surgery

Who may qualify

Ages: 18 to 64 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients identified from the anaesthetic clinic scheduled to undergo a laparoscopic gynaecological procedure under general anaesthesia
American Society of Anaesthesiology (ASA) I-II

Key exclusion criteria (16 listed)

Anticipated difficult airway
Patients requiring rapid sequence induction
Patient anticipated to require admission to the intensive care unit (ICU) or not planned for extubation
Patient with liver or renal failure (creatinine clearance <50mls/min)
Patients with a baseline heart rate <50/min

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
Deep neuromuscular blockadeAlso: Rocuronium, EsmeronDeep neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction of anesthesia with intermittent boluses of 0.15 - 0.2 mg/kg to maintain a Post Tetanic Count (PTC) of 1-2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 4mg/kg.	Drug	moderate neuromuscular blockade
Moderate neuromuscular blockadeAlso: Rocuronium, EsmeronModerate neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction with intermittent boluses of 0.15 - 0.2 mg/kg to maintain Train of Four Count (TOFC) of 2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 2mg/kg.	Drug	deep neuromuscular blockade

Primary outcome

Deep block versus Moderate block: Impact on surgical satisfaction
Time frame: Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score.
The surgeon will be required to score the quality of operating conditions every 15 minutes from 1st visualisation of peritoneal cavity until the removal of laparoscopes at the end of surgery.

3 secondary outcomes

Deep block versus Moderate block: Patient satisfaction score
Time frame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
Deep block versus Moderate block: Pain score
Time frame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU
Deep block versus Moderate block: PONV Score
Time frame: Post Anesthetic Recovery Score done at half hour from time of arrival at PACU and patient deemed fit for discharge up to 2 hours from time of arrival at PACU

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
Background: PubMed 9459231Song D, Joshi GP, White PF. Fast-track eligibility after ambulatory anesthesia: a comparison of desflurane, sevoflurane, and propofol. Anesth Analg. 1998 Feb;86(2):267-73. doi: 10.1097/00000539-199802000-00009.
Background: PubMed 14980911Gupta A, Stierer T, Zuckerman R, Sakima N, Parker SD, Fleisher LA. Comparison of recovery profile after ambulatory anesthesia with propofol, isoflurane, sevoflurane and desflurane: a systematic review. Anesth Analg. 2004 Mar;98(3):632-41, table of contents. doi: 10.1213/01.ane.0000103187.70627.57.
Background: PubMed 15896435Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
Background: PubMed 24240315Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
Background: PubMed 24809482Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
Background: PubMed 22698066Geldner G, Niskanen M, Laurila P, Mizikov V, Hubler M, Beck G, Rietbergen H, Nicolayenko E. A randomised controlled trial comparing sugammadex and neostigmine at different depths of neuromuscular blockade in patients undergoing laparoscopic surgery. Anaesthesia. 2012 Sep;67(9):991-8. doi: 10.1111/j.1365-2044.2012.07197.x. Epub 2012 Jun 14.
Background: PubMed 24427455Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.
Background: PubMed 23519634Carron M, Veronese S, Foletto M, Ori C. Sugammadex allows fast-track bariatric surgery. Obes Surg. 2013 Oct;23(10):1558-63. doi: 10.1007/s11695-013-0926-y.
Background: PubMed 18946293Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
Background: PubMed 23849107Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI Marco P. Reversal of rocuronium induced neuromuscular block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol Scand. 2013 Oct;57(9):1138-45. doi: 10.1111/aas.12155. Epub 2013 Jul 14.
Background: PubMed 22012861Gaszynski T, Szewczyk T, Gaszynski W. Randomized comparison of sugammadex and neostigmine for reversal of rocuronium-induced muscle relaxation in morbidly obese undergoing general anaesthesia. Br J Anaesth. 2012 Feb;108(2):236-9. doi: 10.1093/bja/aer330. Epub 2011 Oct 19.
Background: PubMed 21946094Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Intraoperative acceleromyography monitoring reduces symptoms of muscle weakness and improves quality of recovery in the early postoperative period. Anesthesiology. 2011 Nov;115(5):946-54. doi: 10.1097/ALN.0b013e3182342840.
Individual participant dataSharing planned: Undecided

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
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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.

Vanitha Sivanaser, M.Med Anaes (UM) principal investigator

Kuala Lumpur General Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Deep neuromuscular blockade and Moderate neuromuscular blockade in people with Neuromuscular Blockade, run by Kuala Lumpur General Hospital.

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 16 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: withdrawn, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Deep block versus Moderate block: Impact on surgical satisfaction (time frame: Every 15 minutes from first laparoscopic view till the removal of laparoscopes at the end of surgery or up to 8 hours from 1st score.). 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 NCT02794714, which also lists 15 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 4 Oct 2018.