Magnesium SulfatePhase 4NCT06685705
Comparative Study Between Intrathecal Magnesium Sulfate, Neostigmine and Fentanyl as Adjuvant for Bubivacaine in Postoperative Analgesia in Lower Abdominal Surgeries
A Phase 4 study testing Magnesium Sulfate and Bupivacaine 0.125%, bupivacaine and Neostigmine and fentanyl and bupivacaine in people with Magnesium Sulfate and Neostigmine, run by Assiut University.
Trial summary
Lower abdominal surgeries often result in severe pain, which in turn can cause rapid and shallow breathing, retention of secretions and poor patient compliance. Justifiably, apart from the fear for the surgery outcome, patients are concerned mainly with postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Magnesium Sulfate, Neostigmine, Fentanyl
- What is being tested?
- Magnesium Sulfate and Bupivacaine 0.125%, bupivacaine and Neostigmine and fentanyl and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • the American Society of Anesthesiologists (ASA) classification I-II
- Age >18 up to 55 years old
- Both sex
- Patients who will undergo lower abdominal surgeries
Who cannot join
- • Patients' refusal.
- Patients with morbid obesity, cardiac diseases, hepatic diseases, renal diseases, diabetes mellitus with polyneuritis.
- Patients who were in risk-scoring groups American Society of Anesthesia III-IV.
- Hypertensive patients receiving therapy with adrenergic receptor antagonist, calcium channel blocker and/or angiotensin converting enzyme inhibitor.
- Patients with coagulation disorders, those receiving any anticoagulants.
- Any history of allergy to local anesthetic or other drugs used in the study, patients on examining drugs.
- Any contraindication to spinal anesthesia ( infection at puncture site and increased intracranial tension and Patients with psychiatric illness and neurologic diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Lower abdominal surgeries often result in severe pain, which in turn can cause rapid and shallow breathing, retention of secretions and poor patient compliance. Justifiably, apart from the fear for the surgery outcome, patients are concerned mainly with postoperative pain. If treated inadequately, acute pain can have serious consequences for patient health mainly with postoperative complications, prolonged recovery and increased length of hospital stay. Higher levels of postoperative pain and pain distress are associated with increased morbidity, poorer functional recovery, and reduced quality of life.
Aim of the study To compare the duration, quality of analgesia, and side effects between intrathecal Magnesium sulfate, neostigmine and fentanyl as adjuvant for bubivacaine as postoperative analgesia in lower abdominal surgeries
Read the detailed description
Effective analgesia aims to minimize patients stress response, pain intensity and distress, and side-effects of large single drug doses (typically an opioid). Numerous analgesic options exist for postoperative analgesia after abdominal surgery, including multiple classes of drugs and routes of administration e.g. parenteral, regional, neuraxial analgesia which include (epidural/intrathecal) techniques, truncal nerve blocks, and systemic drugs infusions.
Spinal anesthesia is a widely used technique in lower abdominal surgeries, offering several benefits such as allowing the patient to remain awake during the procedure, quick onset of action, high success rate, minimal drug dosage, effective sensory and motor blocks, and cost-effectiveness. However, despite these advantages, it can also cause side effects like hypotension, bradycardia, nausea, vomiting, and shivering.
Bupivacaine, is a commonly used local anesthetic, but its use can be limited by the duration of action and potential side effects. To enhance the analgesic effects and prolong the duration of bupivacaine, various adjuvants such as magnesium sulfate, neostigmine, and fentanyl are added intrathecally. Each adjuvant offers unique pharmacological properties that can influence spinal anesthesia's efficacy.
Magnesium sulfate, known for its N-methyl-D-aspartate (NMDA) receptor antagonist properties, decreases sensitivity to both central and peripheral pain stimuli by blocking calcium influx and reducing the excitability of NMDA receptors. Several studies have evaluated the role of magnesium sulfate (MgSO4) as an agent for pain control and reduction of analgesia requirement intra-and post-operatively. In some of these studies, researchers concluded that MgSO4 may reduce the need for opioid analgesic agents.
Neostigmine is a water-soluble, ionized compound that inhibits acetylcholinesterase (AChE). Its indication in FDA is to reverse the effect of non-depolarizing neuromuscular blockers after surgery. The drug is usually administered by intravenous injection, and the main route of excretion is the kidney. Neostigmine should be used with caution in patients with coronary heart disease, arrhythmia, recent acute coronary syndrome and myasthenia gravis. Neostigmine works by preventing the breakdown of the neurotransmitter acetylcholine. Recent studies suggest that this inhibition of acetylcholine degradation strengthens the descending modulation of afferent pain signals, offering a novel method for improving analgesia with minimal dose-related side effects. It enhances spinal cholinergic transmission, potentially increasing the analgesic effects without causing respiratory depression.
Fentanyl, a potent opioid, is commonly used as an adjuvant due to its strong analgesic properties, its primary clinical uses include sedation for intubated patients and managing severe pain, especially in those with renal failure, as it's predominantly metabolized by the liver . Fentanyl is also prescribed for chronic pain patients who have developed a tolerance to other opioids. Fentanyl is more lipid soluble than morphine which is more rapidly eliminated from cerebrospinal fluid. It provides dense blockade with complete intra- and postoperative analgesia without causing hemodynamic instability. It has relatively fewer side effects which are manageable and very well tolerated by the patients.
The comparative effectiveness of these adjuvants in prolonging the duration of analgesia, reducing postoperative opioid requirements, and minimizing adverse effects is crucial for improving patient outcomes.
- Conditions
- Magnesium Sulfate, Neostigmine, Fentanyl
- Being tested
- Magnesium Sulfate and Bupivacaine 0.125%, bupivacaine and Neostigmine, fentanyl and bupivacaine
- Keywords
- lower abdominal surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate and Bupivacaine 0.125%Drug
patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally.
bupivacaine and NeostigmineDrug
patients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally
fentanyl and bupivacaineDrug
patients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally. Receives: Drug: Magnesium Sulfate and Bupivacaine 0.125% |
| group 2 | Experimental | patients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally Receives: Drug: bupivacaine and Neostigmine |
| group3 | Experimental | patients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally. Receives: Drug: fentanyl and bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
first request of rescue analgesia
The time of first request of rescue analgesia calculated from the time of spinal anesthesia.
Measured: baseline
Secondary outcomes (1)
post operative VAS score
post operative VAS score
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen mohamed mohsen mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685705
- Sponsor's protocol ID
- MgSO4 neostigmine fentanyl
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu W, Bao S, Chen J, Li Y, Gu Y, Ye Q, Hai K. Bupivacaine-fentanyl isobaric spinal anesthesia reduces the risk of ICU admission in elderly patients undergoing lower limb orthopedic surgery. J Orthop Surg Res. 2024 Mar 1;19(1):160. doi: 10.1186/s13018-024-04618-x.
PubMed 38429736Li LQ, Fang MD, Wang C, Lu HL, Wang LX, Xu HY, Zhang HZ. Comparative evaluation of epidural bupivacaine alone and bupivacaine combined with magnesium sulfate in providing postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Feb 5;20(1):39. doi: 10.1186/s12871-020-0947-8.
PubMed 32024465Prabhakaraiah UN, Narayanappa AB, Gurulingaswamy S, Kempegowda K, Vijaynagar KA, Hanumantharayappa NB, Ramegowda DS. "Comparison of Nalbuphine Hydrochloride and Fentanyl as an Adjuvant to Bupivacaine for Spinal Anesthesia in Lower Abdominal Surgeries:" A Randomized, Double-blind Study. Anesth Essays Res. 2017 Oct-Dec;11(4):859-863. doi: 10.4103/aer.AER_40_17.
PubMed 29284839Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
PubMed 27746548Si S, Zhao X, Su F, Lu H, Zhang D, Sun L, Wang F, Xu L. New advances in clinical application of neostigmine: no longer focusing solely on increasing skeletal muscle strength. Front Pharmacol. 2023 Aug 4;14:1227496. doi: 10.3389/fphar.2023.1227496. eCollection 2023.
PubMed 37601044Liao Y, Li Y, Ouyang W. Effects and safety of neostigmine for postoperative recovery of gastrointestinal function: a systematic review and meta-analysis. Ann Palliat Med. 2021 Dec;10(12):12507-12518. doi: 10.21037/apm-21-3291.
PubMed 35016456Hussien RM, Rabie AH. Sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at different rates: does it make a difference? A randomized controlled trial. Korean J Anesthesiol. 2019 Apr;72(2):150-155. doi: 10.4097/kja.d.18.00173. Epub 2019 Jan 9.
PubMed 30622224Taher-Baneh N, Ghadamie N, Sarshivi F, Sahraie R, Nasseri K. [Comparison of fentanyl and dexmedetomidine as an adjuvant to bupivacaine for unilateral spinal anesthesia in lower limb surgery: a randomized trial]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):369-376. doi: 10.1016/j.bjan.2019.03.005. Epub 2019 Jul 27.
PubMed 31362883Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.
PubMed 35803751
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intrathecal Magnesium Sulfate, Neostigmine and Fentanyl as Adjuvant for Bubivacaine in Postoperative Analgesia in Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06685705
- Acronym / sponsor ID
- MgSO4 neostigmine fentanyl
- Conditions
- Magnesium Sulfate, Neostigmine, Fentanyl
- Keywords
- lower abdominal surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- 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.
Lower abdominal surgeries often result in severe pain, which in turn can cause rapid and shallow breathing, retention of secretions and poor patient compliance. Justifiably, apart from the fear for the surgery outcome, patients are concerned mainly with postoperative pain. If treated inadequately, acute pain can have serious consequences for patient health mainly with postoperative complications, prolonged recovery and increased length of hospital stay. Higher levels of postoperative pain and pain distress are associated with increased morbidity, poorer functional recovery, and reduced quality of life.
Aim of the study To compare the duration, quality of analgesia, and side effects between intrathecal Magnesium sulfate, neostigmine and fentanyl as adjuvant for bubivacaine as postoperative analgesia in lower abdominal surgeries
Detailed description
Effective analgesia aims to minimize patients stress response, pain intensity and distress, and side-effects of large single drug doses (typically an opioid). Numerous analgesic options exist for postoperative analgesia after abdominal surgery, including multiple classes of drugs and routes of administration e.g. parenteral, regional, neuraxial analgesia which include (epidural/intrathecal) techniques, truncal nerve blocks, and systemic drugs infusions.
Spinal anesthesia is a widely used technique in lower abdominal surgeries, offering several benefits such as allowing the patient to remain awake during the procedure, quick onset of action, high success rate, minimal drug dosage, effective sensory and motor blocks, and cost-effectiveness. However, despite these advantages, it can also cause side effects like hypotension, bradycardia, nausea, vomiting, and shivering.
Bupivacaine, is a commonly used local anesthetic, but its use can be limited by the duration of action and potential side effects. To enhance the analgesic effects and prolong the duration of bupivacaine, various adjuvants such as magnesium sulfate, neostigmine, and fentanyl are added intrathecally. Each adjuvant offers unique pharmacological properties that can influence spinal anesthesia's efficacy.
Magnesium sulfate, known for its N-methyl-D-aspartate (NMDA) receptor antagonist properties, decreases sensitivity to both central and peripheral pain stimuli by blocking calcium influx and reducing the excitability of NMDA receptors. Several studies have evaluated the role of magnesium sulfate (MgSO4) as an agent for pain control and reduction of analgesia requirement intra-and post-operatively. In some of these studies, researchers concluded that MgSO4 may reduce the need for opioid analgesic agents.
Neostigmine is a water-soluble, ionized compound that inhibits acetylcholinesterase (AChE). Its indication in FDA is to reverse the effect of non-depolarizing neuromuscular blockers after surgery. The drug is usually administered by intravenous injection, and the main route of excretion is the kidney. Neostigmine should be used with caution in patients with coronary heart disease, arrhythmia, recent acute coronary syndrome and myasthenia gravis. Neostigmine works by preventing the breakdown of the neurotransmitter acetylcholine. Recent studies suggest that this inhibition of acetylcholine degradation strengthens the descending modulation of afferent pain signals, offering a novel method for improving analgesia with minimal dose-related side effects. It enhances spinal cholinergic transmission, potentially increasing the analgesic effects without causing respiratory depression.
Fentanyl, a potent opioid, is commonly used as an adjuvant due to its strong analgesic properties, its primary clinical uses include sedation for intubated patients and managing severe pain, especially in those with renal failure, as it's predominantly metabolized by the liver . Fentanyl is also prescribed for chronic pain patients who have developed a tolerance to other opioids. Fentanyl is more lipid soluble than morphine which is more rapidly eliminated from cerebrospinal fluid. It provides dense blockade with complete intra- and postoperative analgesia without causing hemodynamic instability. It has relatively fewer side effects which are manageable and very well tolerated by the patients.
The comparative effectiveness of these adjuvants in prolonging the duration of analgesia, reducing postoperative opioid requirements, and minimizing adverse effects is crucial for improving patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Magnesium Sulfate and Bupivacaine 0.125%patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally. |
| group 2 | Experimental | Drug: bupivacaine and Neostigminepatients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally |
| group3 | Experimental | Drug: fentanyl and bupivacainepatients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • the American Society of Anesthesiologists (ASA) classification I-II
Key exclusion criteria (7 listed)
- • Patients' refusal.
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 |
|---|---|---|
| Magnesium Sulfate and Bupivacaine 0.125%patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally. | Drug | group 1 |
| bupivacaine and Neostigminepatients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally | Drug | group 2 |
| fentanyl and bupivacainepatients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally. | Drug | group3 |
Primary outcome
first request of rescue analgesia
Time frame: baseline
The time of first request of rescue analgesia calculated from the time of spinal anesthesia.
1 secondary outcome
post operative VAS score
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 38429736Liu W, Bao S, Chen J, Li Y, Gu Y, Ye Q, Hai K. Bupivacaine-fentanyl isobaric spinal anesthesia reduces the risk of ICU admission in elderly patients undergoing lower limb orthopedic surgery. J Orthop Surg Res. 2024 Mar 1;19(1):160. doi: 10.1186/s13018-024-04618-x.
- Results publication: PubMed 32024465Li LQ, Fang MD, Wang C, Lu HL, Wang LX, Xu HY, Zhang HZ. Comparative evaluation of epidural bupivacaine alone and bupivacaine combined with magnesium sulfate in providing postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Feb 5;20(1):39. doi: 10.1186/s12871-020-0947-8.
- Results publication: PubMed 29284839Prabhakaraiah UN, Narayanappa AB, Gurulingaswamy S, Kempegowda K, Vijaynagar KA, Hanumantharayappa NB, Ramegowda DS. "Comparison of Nalbuphine Hydrochloride and Fentanyl as an Adjuvant to Bupivacaine for Spinal Anesthesia in Lower Abdominal Surgeries:" A Randomized, Double-blind Study. Anesth Essays Res. 2017 Oct-Dec;11(4):859-863. doi: 10.4103/aer.AER_40_17.
- Results publication: PubMed 27746548Pandey V, Mohindra BK, Sodhi GS. Comparative evaluation of different doses of intrathecal neostigmine as an adjuvant to bupivacaine for postoperative analgesia. Anesth Essays Res. 2016 Sep-Dec;10(3):538-545. doi: 10.4103/0259-1162.180779.
- Results publication: PubMed 37601044Si S, Zhao X, Su F, Lu H, Zhang D, Sun L, Wang F, Xu L. New advances in clinical application of neostigmine: no longer focusing solely on increasing skeletal muscle strength. Front Pharmacol. 2023 Aug 4;14:1227496. doi: 10.3389/fphar.2023.1227496. eCollection 2023.
- Results publication: PubMed 35016456Liao Y, Li Y, Ouyang W. Effects and safety of neostigmine for postoperative recovery of gastrointestinal function: a systematic review and meta-analysis. Ann Palliat Med. 2021 Dec;10(12):12507-12518. doi: 10.21037/apm-21-3291.
- Results publication: PubMed 30622224Hussien RM, Rabie AH. Sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at different rates: does it make a difference? A randomized controlled trial. Korean J Anesthesiol. 2019 Apr;72(2):150-155. doi: 10.4097/kja.d.18.00173. Epub 2019 Jan 9.
- Results publication: PubMed 31362883Taher-Baneh N, Ghadamie N, Sarshivi F, Sahraie R, Nasseri K. [Comparison of fentanyl and dexmedetomidine as an adjuvant to bupivacaine for unilateral spinal anesthesia in lower limb surgery: a randomized trial]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):369-376. doi: 10.1016/j.bjan.2019.03.005. Epub 2019 Jul 27.
- Results publication: PubMed 35803751Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate and Bupivacaine 0.125%, bupivacaine and Neostigmine and fentanyl and bupivacaine in people with Magnesium Sulfate and Neostigmine, run by Assiut University.
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 7 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: opening soon, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Mohamed Mohsen Mahmoud, resident doctors (+101092209597, mohsen.16266366@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first request of rescue analgesia (time frame: baseline). 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 NCT06685705, which also lists 9 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 12 Nov 2024.