DexmedetomidineNCT06942884
Dexamethasone and Dexmedetomidine Versus Dexmedetomidine Alone With Bupivacaine in Ultrasound Guided Rectus Sheath Block
A study testing Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block and dexamethsone in addition to bupivacaine in rectus sheath block in people with Dexmedetomidine and Dexamethasone, run by sarah mohamed at 1 site in Egypt.
Trial summary
Major abdominal surgery involves a variety of surgical procedures on a variety of patients, necessitating a broad spectrum of pain and analgesic needs. A crucial element of multimodal analgesia that spares the use of opioids is regional anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dexmedetomidine, Dexamethasone, Abdominal Surgeries
- What is being tested?
- Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block and dexamethsone in addition to bupivacaine in rectus sheath block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to Dec 2025
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) physical status I and II.
- Patients aged 18-50 years.
- Body mass index (BMI) less than 30 kg/m2.
- Patients indicated for open abdominal surgeries with midline skin incision under general anaesthesia.
- Elective and haemodynamically stable emergency cases.
Who cannot join
- Patients' refusal.
- History of allergy to any of the study medications.
- Diabetic patients.
- Contraindications to regional anaesthesia, coagulopathy, anatomical abnormalities, haemodynamic instability, local infection, and suspected intra-abdominal sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone and Dexmedetomidine Versus Dexmedetomidine Alone With Bupivacaine in Ultrasound Guided Rectus Sheath Block in Midline Abdominal Surgeries
Major abdominal surgery involves a variety of surgical procedures on a variety of patients, necessitating a broad spectrum of pain and analgesic needs.
A crucial element of multimodal analgesia that spares the use of opioids is regional anaesthesia.
Read more
Rectus sheath block (RSB) is a common regional block for post-operative analgesia after abdominal surgeries with midline incisions. A good analgesic effect has been reported for upper as well as lower abdominal midline incisions.(2) It was firstly described in 1899 with the aim of deposition of local anaesthetic (LA) in the virtual space between the posterior wall of the rectus abdominis muscle and its sheath. The anaesthetic injected into this space is proposed to spread freely up and down to block the anterior branches of the thoracoabdominal nerves before they emerge from the rectus sheath. The ventral branches of the lower thoracic nerves (T6-T12), which are located between the rectus abdominis muscle and its sheath, innervate the central region of the anterior abdominal wall.
In general, a single injection of local anesthetic can give analgesia for 4-12 hours following surgery, depending on the drug's chemical composition and degree of lipid solubility. Since postoperative pain might last for several days, prolonging the duration of action of local anaesthetics is important.(5) To prolong the postoperative analgesic period of local anaesthetics, many adjuncts have been used, including fentanyl, neostigmine, clonidine, and most recently dexamethasone and dexmedetomidine.(6) Dexamethasone is a highly potent, long-acting glucocorticoid. It reduces the activity of nociceptive C-fibres via binding to glucocorticoid receptors, which inhibits potassium conductance. It may also lengthen the duration of analgesia by systemic anti-inflammatory actions and local vasoconstrictive action.
Dexmedetomidine is one of the α -adrenoceptor agonists with α2 -adrenoceptor selectivity with both analgesic and sedative properties. it shortens the duration of the sensory and motor blockade while lengthening the initial blocking time when used as a perineural adjuvant
Read the detailed description
AIM OF THE WORK The aim of the current study is to compare between adding dexamethasone with dexmedetomidine versus dexamethasone alone in ultrasound-guided RSB.
Primary aim:
The total amount of opioids used from completion of surgery till 48 hours.
Secondary aim:
The time to rescue analgesics need, duration of post operative analgesia, severity of postoperative pain at rest and with movement, the quality of recovery and any observed complications.
- PATIENTS After approval of Local Ethics Committee and with written informed consent, this study will be conducted at Alexandria Main University Hospital and will be on 36 patients of both sexes, scheduled for major abdominal surgery.
Inclusion criteria
- American Society of Anaesthesiologists (ASA) physical status I and II.
- Patients aged 18-50 years.
- Body mass index (BMI) less than 30 kg/m2.
- Patients indicated for open abdominal surgeries with midline skin incision under general anaesthesia.
- Elective and haemodynamically stable emergency cases. Exclusion criteria
- Patients' refusal. 2. History of allergy to any of the study medications. 3. Diabetic patients. 4. Contraindications to regional anaesthesia, coagulopathy, anatomical abnormalities, haemodynamic instability, local infection, and suspected intra-abdominal sepsis.
- METHODS
A- Preoperative assessment:
- Proper medical, surgical and drug history.
- General and airway examination.
- Laboratory investigations will be checked including:
Complete blood count (CBC), liver and kidney function tests and coagulation profile.
- Electrocardiography (ECG), and echocardiography (echo) for patients above 40 years.
- All patients will be informed about the study design, the analgesic regimen, and how to express pain intensity with the use of the VAS. The VAS is a 10-cm line corresponding to their pain level, with 0 at one end representing no pain at all and 10 at the other end representing the worst imaginable pain. Also the quality of recovery (QoR-15) (10) questionnaire will be illustrated.
B- Monitoring and patient preparation:
On arrival to the operating theater, an 18-G intravenous (IV) cannula will be inserted and IV Ringer's solution will be started according to the fluid chart of each patient.
Noninvasive blood pressure, pulse oximeter, and electrocardiography will be attached to the patients. Capnography will be attached with induction of general anesthesia.
C- Anaesthetic technique:
General anaesthesia with endotracheal intubation will be induced with 1 μg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium. Anaesthesia was 9. maintained with 1.2% isoflurane in 50% O2 in air mixture; additional boluses of 0.5-1 μg/kg fentanyl and 0.1 mg/kg atracurium will be given every 30 min until the end of the operation.
After completion of surgery, bilateral RSB will be performed under real-time ultrasound guidance (USG) using an in-plane approach. Under sterile precautions, the rectus sheath was identified at its lateral border, and a high-frequency linear probe is placed transversely across the linea semilunaris at or just above the level of the umbilicus. The lateral border of the rectus sheath is identified by the transition from the triple layer of muscle (external oblique, internal oblique, and transversus abdominis) on the lateral side to the single layer of muscle (rectus abdominis) medially. A 22-G needle will be inserted, the needle tip will be identified in-plane approach, and 20 ml of solution will be administered in the fascial plane between the rectus abdominis muscle and posterior wall of the rectus sheath, which is confirmed by hydrodissection under USG guidance.(11)
The 40 patients will be divided into two groups; each group includes 20 patients in double blinded study:
Group 1: Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5% bupivacaine, 20μg dexmedetomidine, 4mg dexamethasone and normal saline.
Group 2: Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5 bupivacaine, with 4mg dexamethasone and normal saline.
After completion of the analgesic intervention, a reversal agent was administered for neuromuscular recovery, and the patient will be extubated and shifted to the recovery room.
- MEASUREMENTS
- Demographic data (Age, Sex, BMI, Type of surgery). 2. The total amount of opioids used from completion of surgery till 48 hours. 3. The time to rescue analgesics need. 4. Duration of post-operative analgesia: Time from completion of the block to the first request of rescue analgesia.
- The severity of post-operative pain at rest: Assessed using the VAS upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12, 24, 30, and 36 post-operative hours. Pain severity was categorized as mild (VAS≤3), moderate (3 ˂ VAS ˂ 7), and severe (VAS≥7).
- The severity of post-operative pain with movement (bilateral knee flexion): Assessed using the VAS upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12, 24, 30, and 36 post-operative hours.
- The quality of recovery by QoR-15 questionnaire: scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively.(12) It is done before surgery as a baseline and after 24 hours.
- Observed complications such as: bleeding, penetration of peritoneum or local anaesthetic toxicity.
- Conditions
- Dexmedetomidine, Dexamethasone, Abdominal Surgeries
- Being tested
- Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block, dexamethsone in addition to bupivacaine in rectus sheath block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath blockDrug
Also called group 1
addition of dexmedetomidine to dexamethasone in rectus sheath block
dexamethsone in addition to bupivacaine in rectus sheath blockDrug
Also called group 2
addition of dexamethasone in rectus sheath block
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5% bupivacaine, 20μg dexmedetomidine, 4mg dexamethasone and normal saline. Receives: Drug: Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block |
| group 2 | Active comparator | Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5 bupivacaine, with 4mg dexamethasone and normal saline Receives: Drug: dexamethsone in addition to bupivacaine in rectus sheath block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
mg
Measured: postoperative day 2
Secondary outcomes (3)
postoperative pain score
0 no pain to 10 sever pain
Measured: postoperative day 2
quality of recovery 15
0-150
Measured: postoperative day 2
complications
bleeding , local anesthetic toxicity
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 Jan 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- sarah mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sarah mohamed, Alexandria University
- Investigators
- sarah m elgamal, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942884
- Sponsor's protocol ID
- 0108165
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pirie 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone and Dexmedetomidine Versus Dexmedetomidine Alone With Bupivacaine in Ultrasound Guided Rectus Sheath Block in Midline Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06942884
- Acronym / sponsor ID
- 0108165
- Conditions
- Dexmedetomidine, Dexamethasone, Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- sarah mohamedUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Apr 2025 (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.
Major abdominal surgery involves a variety of surgical procedures on a variety of patients, necessitating a broad spectrum of pain and analgesic needs.
A crucial element of multimodal analgesia that spares the use of opioids is regional anaesthesia.
Rectus sheath block (RSB) is a common regional block for post-operative analgesia after abdominal surgeries with midline incisions. A good analgesic effect has been reported for upper as well as lower abdominal midline incisions.(2) It was firstly described in 1899 with the aim of deposition of local anaesthetic (LA) in the virtual space between the posterior wall of the rectus abdominis muscle and its sheath. The anaesthetic injected into this space is proposed to spread freely up and down to block the anterior branches of the thoracoabdominal nerves before they emerge from the rectus sheath. The ventral branches of the lower thoracic nerves (T6-T12), which are located between the rectus abdominis muscle and its sheath, innervate the central region of the anterior abdominal wall.
In general, a single injection of local anesthetic can give analgesia for 4-12 hours following surgery, depending on the drug's chemical composition and degree of lipid solubility. Since postoperative pain might last for several days, prolonging the duration of action of local anaesthetics is important.(5) To prolong the postoperative analgesic period of local anaesthetics, many adjuncts have been used, including fentanyl, neostigmine, clonidine, and most recently dexamethasone and dexmedetomidine.(6) Dexamethasone is a highly potent, long-acting glucocorticoid. It reduces the activity of nociceptive C-fibres via binding to glucocorticoid receptors, which inhibits potassium conductance. It may also lengthen the duration of analgesia by systemic anti-inflammatory actions and local vasoconstrictive action.
Dexmedetomidine is one of the α -adrenoceptor agonists with α2 -adrenoceptor selectivity with both analgesic and sedative properties. it shortens the duration of the sensory and motor blockade while lengthening the initial blocking time when used as a perineural adjuvant
Detailed description
AIM OF THE WORK The aim of the current study is to compare between adding dexamethasone with dexmedetomidine versus dexamethasone alone in ultrasound-guided RSB.
Primary aim:
The total amount of opioids used from completion of surgery till 48 hours.
Secondary aim:
The time to rescue analgesics need, duration of post operative analgesia, severity of postoperative pain at rest and with movement, the quality of recovery and any observed complications.
- PATIENTS After approval of Local Ethics Committee and with written informed consent, this study will be conducted at Alexandria Main University Hospital and will be on 36 patients of both sexes, scheduled for major abdominal surgery.
Inclusion criteria
- American Society of Anaesthesiologists (ASA) physical status I and II.
- Patients aged 18-50 years.
- Body mass index (BMI) less than 30 kg/m2.
- Patients indicated for open abdominal surgeries with midline skin incision under general anaesthesia.
- Elective and haemodynamically stable emergency cases. Exclusion criteria
- Patients' refusal. 2. History of allergy to any of the study medications. 3. Diabetic patients. 4. Contraindications to regional anaesthesia, coagulopathy, anatomical abnormalities, haemodynamic instability, local infection, and suspected intra-abdominal sepsis.
- METHODS
A- Preoperative assessment:
- Proper medical, surgical and drug history.
- General and airway examination.
- Laboratory investigations will be checked including:
Complete blood count (CBC), liver and kidney function tests and coagulation profile.
- Electrocardiography (ECG), and echocardiography (echo) for patients above 40 years.
- All patients will be informed about the study design, the analgesic regimen, and how to express pain intensity with the use of the VAS. The VAS is a 10-cm line corresponding to their pain level, with 0 at one end representing no pain at all and 10 at the other end representing the worst imaginable pain. Also the quality of recovery (QoR-15) (10) questionnaire will be illustrated.
B- Monitoring and patient preparation:
On arrival to the operating theater, an 18-G intravenous (IV) cannula will be inserted and IV Ringer's solution will be started according to the fluid chart of each patient.
Noninvasive blood pressure, pulse oximeter, and electrocardiography will be attached to the patients. Capnography will be attached with induction of general anesthesia.
C- Anaesthetic technique:
General anaesthesia with endotracheal intubation will be induced with 1 μg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium. Anaesthesia was 9. maintained with 1.2% isoflurane in 50% O2 in air mixture; additional boluses of 0.5-1 μg/kg fentanyl and 0.1 mg/kg atracurium will be given every 30 min until the end of the operation.
After completion of surgery, bilateral RSB will be performed under real-time ultrasound guidance (USG) using an in-plane approach. Under sterile precautions, the rectus sheath was identified at its lateral border, and a high-frequency linear probe is placed transversely across the linea semilunaris at or just above the level of the umbilicus. The lateral border of the rectus sheath is identified by the transition from the triple layer of muscle (external oblique, internal oblique, and transversus abdominis) on the lateral side to the single layer of muscle (rectus abdominis) medially. A 22-G needle will be inserted, the needle tip will be identified in-plane approach, and 20 ml of solution will be administered in the fascial plane between the rectus abdominis muscle and posterior wall of the rectus sheath, which is confirmed by hydrodissection under USG guidance.(11)
The 40 patients will be divided into two groups; each group includes 20 patients in double blinded study:
Group 1: Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5% bupivacaine, 20μg dexmedetomidine, 4mg dexamethasone and normal saline.
Group 2: Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5 bupivacaine, with 4mg dexamethasone and normal saline.
After completion of the analgesic intervention, a reversal agent was administered for neuromuscular recovery, and the patient will be extubated and shifted to the recovery room.
- MEASUREMENTS
- Demographic data (Age, Sex, BMI, Type of surgery). 2. The total amount of opioids used from completion of surgery till 48 hours. 3. The time to rescue analgesics need. 4. Duration of post-operative analgesia: Time from completion of the block to the first request of rescue analgesia.
- The severity of post-operative pain at rest: Assessed using the VAS upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12, 24, 30, and 36 post-operative hours. Pain severity was categorized as mild (VAS≤3), moderate (3 ˂ VAS ˂ 7), and severe (VAS≥7).
- The severity of post-operative pain with movement (bilateral knee flexion): Assessed using the VAS upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12, 24, 30, and 36 post-operative hours.
- The quality of recovery by QoR-15 questionnaire: scores for excellent, good, moderate, and poor recovery were 136-150, 122-135, 90-121, and 0-89, respectively.(12) It is done before surgery as a baseline and after 24 hours.
- Observed complications such as: bleeding, penetration of peritoneum or local anaesthetic toxicity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath blockPatients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5% bupivacaine, 20μg dexmedetomidine, 4mg dexamethasone and normal saline. |
| group 2 | Active comparator | Drug: dexamethsone in addition to bupivacaine in rectus sheath blockPatients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5 bupivacaine, with 4mg dexamethasone and normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- American Society of Anaesthesiologists (ASA) physical status I and II.
- Patients aged 18-50 years.
- Body mass index (BMI) less than 30 kg/m2.
- Patients indicated for open abdominal surgeries with midline skin incision under general anaesthesia.
- Elective and haemodynamically stable emergency cases.
Key exclusion criteria (4 listed)
- Patients' refusal.
- History of allergy to any of the study medications.
- Diabetic patients.
- Contraindications to regional anaesthesia, coagulopathy, anatomical abnormalities, haemodynamic instability, local infection, and suspected intra-abdominal sepsis.
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 |
|---|---|---|
| Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath blockAlso: group 1addition of dexmedetomidine to dexamethasone in rectus sheath block | Drug | group 1 |
| dexamethsone in addition to bupivacaine in rectus sheath blockAlso: group 2addition of dexamethasone in rectus sheath block | Drug | group 2 |
Primary outcome
postoperative opioid consumption
Time frame: postoperative day 2
mg
3 secondary outcomes
postoperative pain score
Time frame: postoperative day 2
quality of recovery 15
Time frame: postoperative day 2
complications
Time frame: postoperative day 2
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 24 Apr 2025.
- Background: 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: No
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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.
sarah m elgamal, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block and dexamethsone in addition to bupivacaine in rectus sheath block in people with Dexmedetomidine and Dexamethasone, run by sarah mohamed at 1 site in Egypt.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
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?
postoperative opioid consumption (time frame: postoperative day 2). 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 NCT06942884, which also lists 1 linked publication.
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 24 Apr 2025.