Emergence AgitationPhase 4NCT05624424
Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery
A Phase 4 study testing Rematazolam Besylate, Propofol and Sevoflurane in people with Emergence Agitation and Remimazolam Besylate, run by Second Affiliated Hospital of Nanchang University at 6 sites in China.
Trial summary
Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergence Agitation, Remimazolam Besylate, Perioperative Sedation
- What is being tested?
- Rematazolam Besylate, Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,317 participants
- Where
- 6 sitesChina
- Study dates
- 15 Nov 2022to 31 Oct 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Aged 18-65 years, sex was not limited;
- 2 BMI 18-30kg/m2;
- 3 Patients were scheduled for elective laparoscopic abdominal surgery under general anesthesia, the operation time 2h~4h;
- 4 ASA Ⅰ-III;
Who cannot join
- 1 Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications;
- 2 Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN;
- 3 People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment;
- 4 Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack;
- 5 Female pregnant patients;
- 6 Patients undergoing hepatobiliary surgery;
- 7 Allergy to the experimental drug;
- 8 Unable to cooperate to complete the test, the patient or family member rejected the participant;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
People's Hospital of Ganzhou
Ganzhou, Jiangxi
Guiming Huang, professor, +8615907977699, liyouchun2007@163.com
the First Affiliated Hospital of Gannan Medical College, Gannan Medical College
Ganzhou, Jiangxi
Maolin Zhong, professor, +8613607978802, zml8802@163.com
The First People's Hospital of JiuJiang
Jiujiang, Jiangxi
Shenghong Zhong, professor, +8613607926616, jjmazui@163.com
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi
Fuzhou Hua, professor, +8615170238929, huafuzhou@126.com
Tumor Hospital of Jiangxi Province
Nanchang, Jiangxi
Huaping Xiao, professor, +8613507082466, 463568985@qq.com
Shangrao People's Hospital
Shangrao, Jiangxi
Guoxiong Lin, professor, +8613707033801, lgxmaz@163.com
About this study
Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources.
Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.
- Conditions
- Emergence Agitation, Remimazolam Besylate, Perioperative Sedation, Laparoscopic Abdominal Surgery, Anesthesia, General
- Being tested
- Rematazolam Besylate, Propofol, Sevoflurane, Sufentanil, Cisatracurium Besylate
- Keywords
- Emergence Agitation, Remimazolam Besylate, Propofol, Sevoflurane, Laparoscopic Abdominal Surgery, Perioperative Sedation, Anesthesia, General
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rematazolam BesylateDrug
Anesthesia was induced with Rematazolam Besylate 0.3~0.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 1-3 mg/kg/h until the end of surgery.
PropofolDrug
Anesthesia was induced with Propofol 2~2.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 5~12 mg/kg/h until the end of surgery.
SevofluraneDrug
Anesthesia was induced with etomidate 0.03 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by 2 %-3 % Sevoflorane until the end of surgery.
SufentanilDrug
Anesthesia was induced with Sufentanil 0.3~0.5 ug/kg by intravenous injection after the LoC and BIS<60.
Cisatracurium BesylateDrug
Anesthesia was induced with cisatracurium besilate 0.2-0.3 mg/kg by intravenous injection after the LoC and BIS<60, followed by 0.1 mg/kg/h Cisatracurium Besylate during the operation.
RemifentanilDrug
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Besylate | Experimental | Induction of anesthesia Slowly inject Remimazolam Besylate 0.3~0.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional Remimazolam Besylate (0.05 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. Receives: Drug: Rematazolam Besylate; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil |
| Propofol | Active comparator | Induction of anesthesia Slowly inject Propofol 2~2.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional Propofol (0.5 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. Receives: Drug: Propofol; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil |
| Sevoflurane | Active comparator | Induction of anesthesia Slowly inject Etomidate 0.03 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional etomidate (0.03 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. Receives: Drug: Sevoflurane; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation
The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.
Measured: Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
The incidence of emergence agitation
The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.
Measured: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary outcomes (12)
Systolic pressure
Measured: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Diastolic pressure
Measured: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Mean pressure
Measured: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Heart rate
Measured: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Recovery times
Recovery times is defined as the period from discontinuation of anesthetic drugs to the recovery of the patient's self-consciousness and can respond correctly to external stimuli.
Measured: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Measured: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
The incidence of postoperative delirium
The incidence of postoperative delirium was assessed using CAM Scale.
Measured: Record in the mornings on the 1st, 3rd and 7th day after operation.
Postoperative Pain
The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.
Measured: Record in the mornings on the 1st, 3rd and 7th day after operation.
Complication
All the perioperative complications are recorded.
Measured: During the perioperative period, up to 1 week.
Hospitalization time
The length of hospital stay is recorded.
Measured: After the patient is discharged from the hospital, average 1 week.
Hospital expenses
Hospitalization costs include total hospitalization costs and anesthesia costs.
Measured: After the patient is discharged from the hospital, average 1 week.
30-day all-cause mortality
30-day all-cause mortality is recorded.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a RCTs.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,317 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624424
- Sponsor's protocol ID
- 2022-EA-2
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05624424
- Acronym / sponsor ID
- 2022-EA-2
- Conditions
- Emergence Agitation, Remimazolam Besylate, Perioperative Sedation, Laparoscopic Abdominal Surgery, Anesthesia, General
- Keywords
- Emergence Agitation, Remimazolam Besylate, Propofol, Sevoflurane, Laparoscopic Abdominal Surgery, Perioperative Sedation, Anesthesia, General
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,317 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 Nov 2022 (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.
Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources.
Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a RCTs.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Besylate | Experimental | Drug: Rematazolam Besylate, Drug: Sufentanil, Drug: Cisatracurium Besylate, Drug: RemifentanilInduction of anesthesia Slowly inject Remimazolam Besylate 0.3~0.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional Remimazolam Besylate (0.05 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. |
| Propofol | Active comparator | Drug: Propofol, Drug: Sufentanil, Drug: Cisatracurium Besylate, Drug: RemifentanilInduction of anesthesia Slowly inject Propofol 2~2.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional Propofol (0.5 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. |
| Sevoflurane | Active comparator | Drug: Sevoflurane, Drug: Sufentanil, Drug: Cisatracurium Besylate, Drug: RemifentanilInduction of anesthesia Slowly inject Etomidate 0.03 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS<60, if the degree of sedation is insufficient, additional etomidate (0.03 mg/kg each time) is allowed. After the LoC, sufentanil 0.3~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1 Aged 18-65 years, sex was not limited;
- 2 BMI 18-30kg/m2;
- 3 Patients were scheduled for elective laparoscopic abdominal surgery under general anesthesia, the operation time 2h~4h;
- 4 ASA Ⅰ-III;
Key exclusion criteria (8 listed)
- 1 Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications;
- 2 Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN;
- 3 People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment;
- 4 Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack;
- 5 Female pregnant patients;
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 |
|---|---|---|
| Rematazolam BesylateAnesthesia was induced with Rematazolam Besylate 0.3~0.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 1-3 mg/kg/h until the end of surgery. | Drug | Remimazolam Besylate |
| PropofolAnesthesia was induced with Propofol 2~2.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 5~12 mg/kg/h until the end of surgery. | Drug | Propofol |
| SevofluraneAnesthesia was induced with etomidate 0.03 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by 2 %-3 % Sevoflorane until the end of surgery. | Drug | Sevoflurane |
| SufentanilAnesthesia was induced with Sufentanil 0.3~0.5 ug/kg by intravenous injection after the LoC and BIS<60. | Drug | Propofol, Remimazolam Besylate, Sevoflurane |
| Cisatracurium BesylateAnesthesia was induced with cisatracurium besilate 0.2-0.3 mg/kg by intravenous injection after the LoC and BIS<60, followed by 0.1 mg/kg/h Cisatracurium Besylate during the operation. | Drug | Propofol, Remimazolam Besylate, Sevoflurane |
| RemifentanilAfter the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery. | Drug | Propofol, Remimazolam Besylate, Sevoflurane |
Primary outcome
The incidence of emergence agitation
Time frame: Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.
The incidence of emergence agitation
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.
12 secondary outcomes
Systolic pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Diastolic pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Mean pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Heart rate
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Recovery times
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Delayed emergence
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
The incidence of postoperative delirium
Time frame: Record in the mornings on the 1st, 3rd and 7th day after operation.
Postoperative Pain
Time frame: Record in the mornings on the 1st, 3rd and 7th day after operation.
Complication
Time frame: During the perioperative period, up to 1 week.
Hospitalization time
Time frame: After the patient is discharged from the hospital, average 1 week.
Hospital expenses
Time frame: After the patient is discharged from the hospital, average 1 week.
30-day all-cause mortality
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rematazolam Besylate, Propofol and Sevoflurane in people with Emergence Agitation and Remimazolam Besylate, run by Second Affiliated Hospital of Nanchang University at 6 sites in China.
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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua, professor (+8615170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of emergence agitation (time frame: Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.). 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?
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 22 Nov 2022.