Postoperative ConfusionPhase 4NCT02631135
Cognitive Functions After TIVA With Dexmedetomidine
A Phase 4 study testing Remifentanil, Propofol and Dexmedetomidine in people with Postoperative Confusion, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Confusion
- What is being tested?
- Remifentanil, Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- under going lumbar disk hernia operation
- 20-60 years old
- ASA (American Society of Anesthesiologists Physical Status classification) classification I-II
Who cannot join
- pregnants
- Patients with hepatic, renal or neurological diseases and
- patients using sedative- hypnotic, anticonvulsive and stimulant drugs
- One of the patient excluded from the study (can not be able to reached after surgery)
Trial locations and contacts
1 site in 1 country.
About this study
It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in TİVA. Together with this effects, it has been considered that the disorder of the cognitive functions in postoperative period and the need for anesthetic drugs in postoperative period will be less.
After the approval of the Ethics Committee and the patients being informed and taking informed consent from them 18 female 23 male totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients have been divided into two groups by closed envelope drawing method, randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State Examination) during the premedication visit. For this study group Standardized Mini Mental Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained patients, and test composed of question-answer in order to calculate the remembering, caution and calculation structure and the scores were recorded. All patients had received the same anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was applied as opioid and was arranged according to the tension artery and heart rate). In the dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After the operation all patients have taken to the recovery room.
Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.
Read the detailed description
After the approve of the Ethics Committee and the patients were informed and taken informed consent form from them (18 female and 23 male) totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients with hepatic, renal or neurological diseases and using sedative- hypnotic, anticonvulsive and stimulant drugs and pregnant patients were excluded. Then they have been divided into two groups by closed envelope drawing method randomly and were allowed to stay hungry at least 8 hours. All the patients were applied the cognitive functions during the premedication visit MMSE (Mini Mental State Examination) that has quite practical usage and the test called Standardized Mini Mental Test Examination(SMMT-E) for the untrained persons. Test composed of question-answer in order to calculate the remembering, caution and calculation structure. All patients SMMTE scores were recorded. In the operation room, patients were applied the standard D-II derivation electrocardiography, heart beat rate, non-invasive arterial pressure, peripheral oxygen saturation (SpO2) and Bispectral Index (BİS) monitorization. Serum sale infusion was started by opening the vascular access with 18-20 gauge cannula. The skin of forehead and the temporal side were cleaned with alcohol cotton for the BİS monitorization. The electrode in the proximal part of the three electrodes of disposable BİS sensor was adhered to the middle of the forehead; the distal electrode to the temporal area on the eye line and the other electrode in between them both were adhered. The BİS values (BİS Monitor, Aspect, USA) were continuously monitored. The Group I (TİVA, n= 20) were received propofol-remifentanil and the Grup II (TİVA+D, n= 20) propofol- remifentanil and additional dexmedetomidine infusion.
Induction of propofol infusion in all two groups was started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS values were arranged between 40-60 until the end of the operation. At the same time remifentanil infusion 0.5 μg.kg-1 was applied as opioid and arranged according to the tension artery and heart rate. The dexmedetomidine infusion has been started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After intubation the carbon dioxide concentration was recorded in all periods.
The patients were ventilated mechanically after the intubation in order to be ETCO2 (end-tidal carbon dioxide) 30-44 mmHg, tidal volume 8-10 mL. kg-1 . In case of tachycardia or hypertension the opioid dose was reduced in case of bradycardia or hypertension while the opioid dose was being increased. Propofol infusion was arranged to be kept in between BİS score 40-50. The effect of the used muscle relaxant was returned by neostigmine 0,05- 0,07 mg. kg-1 i.v. and atropin 0,03 mg. kg -1 i.v. After the operation all patients have been taken to the recovery room.
Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.
- Conditions
- Postoperative Confusion
- Being tested
- Remifentanil, Propofol, Dexmedetomidine, Rocuronium
- Keywords
- Dexmedetomidine, cognitive functions, MMSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called ultiva
In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
PropofolDrug
BIS values were arranged 40-60 until the end of operation
DexmedetomidineDrug
Also called precedex
0.5 microgram/kg infusion, no changes
RocuroniumDrug
Also called esmeron
0.5 mg/kg iv for intubation, no changes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TIVA) | Placebo comparator | Only propofol (started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1) and rocuronium for intubation Receives: Drug: Remifentanil; Drug: Propofol; Drug: Rocuronium |
| Group 2 (TIVA+D) | Active comparator | Propofol started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1),and also dexmedetomidine infusion (started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made during the operation) and rocuronium for intubation Receives: Drug: Remifentanil; Drug: Propofol; Drug: Dexmedetomidine; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery
The cognitive function evaluation performed by MMSE test at the second hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Measured: Postoperative hour 2
Mini Mental State Examination (MMSE) Score at the First Month After Surgery
The cognitive function evaluation performed by MMSE test at the one month of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Measured: Postoperative month one
Mini Mental State Examination (MMSE) Score at the First Week After Surgery
The cognitive function evaluation performed by MMSE test at the one week of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Measured: postoperative week one
Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery
The cognitive function evaluation performed by MMSE test at the 24th hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Measured: Postoperative hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative ConfusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Aksu Erdost, Uludag University
- Investigators
- Hulya Bilgin, professor, Study director, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631135
- Sponsor's protocol ID
- 2007-21/18
- Status last verified
- Aug 2020
- First submitted
- 30 Nov 2015
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.
PubMed 9447431Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.
PubMed 16037733Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
PubMed 16803911Weinbroum AA, Geller E. Flumazenil improves cognitive and neuromotor emergence and attenuates shivering after halothane-, enflurane- and isoflurane-based anesthesia. Can J Anaesth. 2001 Nov;48(10):963-72. doi: 10.1007/BF03016585.
PubMed 11698314Kostopanagiotou G, Markantonis SL, Polydorou M, Pandazi A, Kottis G. Recovery and cognitive function after fentanyl or remifentanil administration for carotid endarterectomy. J Clin Anesth. 2005 Feb;17(1):16-20. doi: 10.1016/j.jclinane.2004.03.008.
PubMed 15721724
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functions After TIVA With Dexmedetomidine
- ClinicalTrials.gov ID
- NCT02631135
- Acronym / sponsor ID
- 2007-21/18
- Conditions
- Postoperative Confusion
- Keywords
- Dexmedetomidine, cognitive functions, MMSE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine would reduce the use of anesthetics drugs in TİVA. Together with this effects, it has been considered that the disorder of the cognitive functions in postoperative period and the need for anesthetic drugs in postoperative period will be less.
After the approval of the Ethics Committee and the patients being informed and taking informed consent from them 18 female 23 male totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients have been divided into two groups by closed envelope drawing method, randomly. All patients cognitive functions were evaluated by MMSE (Mini Mental State Examination) during the premedication visit. For this study group Standardized Mini Mental Test Examination (SMMT-E) were used, which has quite practical usage, for the untrained patients, and test composed of question-answer in order to calculate the remembering, caution and calculation structure and the scores were recorded. All patients had received the same anesthesia induction with propofol infusion (started at firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS(bispectral index) values were arranged between 40-60 until the end of the operation), and remifentanil infusion (0.5 μg.kg-1 was applied as opioid and was arranged according to the tension artery and heart rate). In the dexmedetomidine group, dexmedetomidine infusion had started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After the operation all patients have taken to the recovery room.
Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.
Detailed description
After the approve of the Ethics Committee and the patients were informed and taken informed consent form from them (18 female and 23 male) totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients with hepatic, renal or neurological diseases and using sedative- hypnotic, anticonvulsive and stimulant drugs and pregnant patients were excluded. Then they have been divided into two groups by closed envelope drawing method randomly and were allowed to stay hungry at least 8 hours. All the patients were applied the cognitive functions during the premedication visit MMSE (Mini Mental State Examination) that has quite practical usage and the test called Standardized Mini Mental Test Examination(SMMT-E) for the untrained persons. Test composed of question-answer in order to calculate the remembering, caution and calculation structure. All patients SMMTE scores were recorded. In the operation room, patients were applied the standard D-II derivation electrocardiography, heart beat rate, non-invasive arterial pressure, peripheral oxygen saturation (SpO2) and Bispectral Index (BİS) monitorization. Serum sale infusion was started by opening the vascular access with 18-20 gauge cannula. The skin of forehead and the temporal side were cleaned with alcohol cotton for the BİS monitorization. The electrode in the proximal part of the three electrodes of disposable BİS sensor was adhered to the middle of the forehead; the distal electrode to the temporal area on the eye line and the other electrode in between them both were adhered. The BİS values (BİS Monitor, Aspect, USA) were continuously monitored. The Group I (TİVA, n= 20) were received propofol-remifentanil and the Grup II (TİVA+D, n= 20) propofol- remifentanil and additional dexmedetomidine infusion.
Induction of propofol infusion in all two groups was started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1 and the BIS values were arranged between 40-60 until the end of the operation. At the same time remifentanil infusion 0.5 μg.kg-1 was applied as opioid and arranged according to the tension artery and heart rate. The dexmedetomidine infusion has been started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made. Rocuronium 0.5 mg. kg-1 iv. was applied for the endotracheal intubation. After intubation the carbon dioxide concentration was recorded in all periods.
The patients were ventilated mechanically after the intubation in order to be ETCO2 (end-tidal carbon dioxide) 30-44 mmHg, tidal volume 8-10 mL. kg-1 . In case of tachycardia or hypertension the opioid dose was reduced in case of bradycardia or hypertension while the opioid dose was being increased. Propofol infusion was arranged to be kept in between BİS score 40-50. The effect of the used muscle relaxant was returned by neostigmine 0,05- 0,07 mg. kg-1 i.v. and atropin 0,03 mg. kg -1 i.v. After the operation all patients have been taken to the recovery room.
Then the tests of cognitive function evaluation were repeated as postoperative 2nd hour, 24 hours, 1 week and 1 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TIVA) | Placebo comparator | Drug: Remifentanil, Drug: Propofol, Drug: RocuroniumOnly propofol (started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1) and rocuronium for intubation |
| Group 2 (TIVA+D) | Active comparator | Drug: Remifentanil, Drug: Propofol, Drug: Dexmedetomidine, Drug: RocuroniumPropofol started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1),and also dexmedetomidine infusion (started as 0.5 μg.kg-1 without making the loading dose and the dose change was not made during the operation) and rocuronium for intubation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- under going lumbar disk hernia operation
- 20-60 years old
- ASA (American Society of Anesthesiologists Physical Status classification) classification I-II
Key exclusion criteria (4 listed)
- pregnants
- Patients with hepatic, renal or neurological diseases and
- patients using sedative- hypnotic, anticonvulsive and stimulant drugs
- One of the patient excluded from the study (can not be able to reached after surgery)
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 |
|---|---|---|
| RemifentanilAlso: ultivaIn case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased | Drug | Group 1 (TIVA), Group 2 (TIVA+D) |
| PropofolBIS values were arranged 40-60 until the end of operation | Drug | Group 1 (TIVA), Group 2 (TIVA+D) |
| DexmedetomidineAlso: precedex0.5 microgram/kg infusion, no changes | Drug | Group 2 (TIVA+D) |
| RocuroniumAlso: esmeron0.5 mg/kg iv for intubation, no changes | Drug | Group 1 (TIVA), Group 2 (TIVA+D) |
Primary outcome
Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery
Time frame: Postoperative hour 2
The cognitive function evaluation performed by MMSE test at the second hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Mini Mental State Examination (MMSE) Score at the First Month After Surgery
Time frame: Postoperative month one
The cognitive function evaluation performed by MMSE test at the one month of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Mini Mental State Examination (MMSE) Score at the First Week After Surgery
Time frame: postoperative week one
The cognitive function evaluation performed by MMSE test at the one week of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Mini Mental State Examination (MMSE) Score at the 24th Hour After Surgery
Time frame: Postoperative hour 24
The cognitive function evaluation performed by MMSE test at the 24th hour of the surgery The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9447431Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.
- Background: PubMed 16037733Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.
- Background: PubMed 16803911Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
- Results publication: PubMed 11698314Weinbroum AA, Geller E. Flumazenil improves cognitive and neuromotor emergence and attenuates shivering after halothane-, enflurane- and isoflurane-based anesthesia. Can J Anaesth. 2001 Nov;48(10):963-72. doi: 10.1007/BF03016585.
- Results publication: PubMed 15721724Kostopanagiotou G, Markantonis SL, Polydorou M, Pandazi A, Kottis G. Recovery and cognitive function after fentanyl or remifentanil administration for carotid endarterectomy. J Clin Anesth. 2005 Feb;17(1):16-20. doi: 10.1016/j.jclinane.2004.03.008.
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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.
Hulya Bilgin, professor study director
Uludag University
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 Remifentanil, Propofol and Dexmedetomidine in people with Postoperative Confusion, run by Uludag University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 17 May 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mini Mental State Examination (MMSE) Score at the Second Hour After Surgery (time frame: Postoperative hour 2). The study lists 4 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 NCT02631135, which also lists 5 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 17 May 2024.