Propofol Injection PainPhase 4NCT07912567
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
A Phase 4 study testing Midazolam, Lidocaine Hydrochloride 2% and Propofol 1% in people with Propofol Injection Pain and Postoperative Recall of Pain, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Propofol is the most commonly used intravenous drug to start general anesthesia (induction). However, it often causes pain in the arm during injection, and remembering this pain after surgery can negatively affect the patient's experience and comfort. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Propofol Injection Pain, Postoperative Recall of Pain, Preoperative Anxiety
- What is being tested?
- Midazolam, Lidocaine Hydrochloride 2% and Propofol 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Mar 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent
- Scheduled for elective surgery
- American Society of Anesthesiologists (ASA) physical status I-II
- Aged 18 to 65 years
- Body mass index (BMI) < 30 kg/m2
- A single peripheral intravenous catheter (20 G) placed on the dorsum of the hand
- Planned induction of anesthesia with propofol
Who cannot join
- Chronic pain disorder lasting longer than three months
- Use of gabapentin or similar neuropathic pain medications
- Opioid dependence
- Development of a surgery-related complication during or after the operation
- Liver or kidney failure
- Moderate or severe cardiovascular or respiratory disease
Show all 9Show fewer
- BMI >= 30 kg/m2
- Allergy to any of the study drugs
- Vulnerable populations: restricted persons, children, pregnant women, women in the postpartum period, breastfeeding women, intensive care patients, unconscious individuals, or persons unable to personally give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Atlas University Faculty of Medicine Hospital
Istanbul
About this study
Official title: Effects of Midazolam Administered at Induction on the Recall of Propofol Injection Pain: A Prospective, Randomized, Controlled, Double-Blind Clinical Trial
Propofol is the most commonly used intravenous drug to start general anesthesia (induction). However, it often causes pain in the arm during injection, and remembering this pain after surgery can negatively affect the patient's experience and comfort. Adding lidocaine (a local anesthetic) to propofol reduces this pain but does not prevent it in every patient. Midazolam is a medicine commonly given to reduce anxiety, and it can also reduce the memory of events that occur after it is given (anterograde amnesia). It is not known whether midazolam reduces the memory of propofol injection pain after surgery.
In this study, adult volunteers aged 18 to 65 who are scheduled for elective surgery will be randomly assigned to one of three groups: (1) a low sedative dose of midazolam before propofol, (2) propofol mixed with lidocaine, or (3) propofol alone. Neither the participants nor the investigator giving the medication will know which group a participant is in. After surgery, once participants have recovered sufficiently, they will be asked whether they remember pain at the injection site during propofol injection. The study will also assess the severity of injection pain and the relationship between anxiety before surgery and injection pain.
All drugs used in this study are approved medicines given at doses used in routine anesthesia practice.
Read the detailed description
Rationale: Propofol injection pain is common, and recalling it after surgery negatively affects patient experience and comfort. Adding lidocaine to propofol reduces injection pain but is not effective in all patients. Midazolam produces marked anterograde amnesia, but its effect on the postoperative recall of propofol injection pain is not well established. This study aims to separate the independent amnestic effect of midazolam on recall of injection pain from the indirect effect of lidocaine on pain intensity.
Procedures: Eligible participants are screened before surgery, written informed consent is obtained, and preoperative anxiety is measured with a 0-10 Visual Analog Scale (VAS). Participants are randomized 1:1:1 using computer-generated block randomization (variable block sizes of 6 and 9). Allocation concealment is ensured with opaque, sequentially numbered envelopes. An anesthesia technician who is not involved in the assessments opens the envelope and prepares and labels freshly prepared, coded syringes for each participant. The investigator administering the study medication and the participant remain blinded to group allocation until the evaluation is complete. All participants are monitored with ECG, pulse oximetry, and non-invasive blood pressure.Sedation level before induction is assessed with the Ramsay Sedation Scale. Propofol injection pain during induction is graded by the investigator on a 4-point scale (1: no pain; 2: mild arm withdrawal; 3: marked arm withdrawal; 4: verbal expression of pain). In the recovery unit, adequate recovery is determined using the Modified Aldrete Score. After adequate recovery, participants are asked whether they remember pain at the injection site during propofol injection.
Safety: Emergency intubation and resuscitation equipment, flumazenil (midazolam antidote), atropine, epinephrine, and corticosteroids/antihistamines are kept immediately available. The technician who prepared the study solution remains next to the blinded investigator during administration to disclose the contents and dose if an emergency occurs. There is no independent data monitoring committee.
Statistical analysis: Analyses are performed with IBM SPSS Statistics version 24. Recall rates and pain incidence are compared between groups with the chi-square test (Fisher's exact test when required); pain severity is compared with the Kruskal-Wallis test; continuous variables are compared with one-way ANOVA or Kruskal-Wallis depending on distribution. The relationship between preoperative anxiety and injection pain is assessed with Spearman correlation. Sample size was calculated with G*Power 3.1.9.7 (80% power, two-sided alpha 0.05); 45 participants per group were required, and 50 per group (150 total) were planned to allow for dropouts.
- Being tested
- Midazolam, Lidocaine Hydrochloride 2%, Propofol 1%, Sodium Chloride 0.9%
- Keywords
- Midazolam, Propofol, Lidocaine, Injection Pain, Anterograde Amnesia, Anesthesia Induction, Recall, Randomized Controlled Trial
- Medical subject headings
- Amnesia, Anterograde
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Zolamid
Single intravenous dose of midazolam at an age-adjusted sedative dose (0.06 mg/kg for ages 18-30, 0.05 mg/kg for ages 31-50, 0.04 mg/kg for ages 51-65), diluted with 0.9% sodium chloride to a total volume of 5 mL and given before induction of anesthesia with propofol.
Lidocaine Hydrochloride 2%Drug
Also called Lidon
Lidocaine 2% (total 40 mg) mixed in the same syringe with propofol 1% (200 mg propofol : 40 mg lidocaine) and given intravenously as a single dose during induction.
Propofol 1%Drug
Also called Propofol-PF
Propofol 1% (10 mg/mL), 2-3 mg/kg administered intravenously over 30 seconds through a 20 G dorsal hand vein catheter as the standard induction agent in all groups.
Sodium Chloride 0.9%Drug
Also called Normal saline
5 mL of 0.9% sodium chloride given intravenously before propofol induction as a carrier/placebo solution to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Group M (Midazolam + Propofol) | Experimental | Participants receive midazolam at an age-adjusted sedative dose, diluted with 0.9% sodium chloride to 5 mL, before induction, followed by propofol 1% 2-3 mg/kg over 30 seconds. Receives: Drug: Midazolam; Drug: Propofol 1% |
| Group L (Lidocaine-Propofol Mixture) | Active comparator | Participants receive 5 mL of 0.9% sodium chloride before induction, followed by a mixture of propofol 1% and lidocaine 2% (200 mg propofol with 40 mg lidocaine) at 2-3 mg/kg propofol over 30 seconds. Receives: Drug: Lidocaine Hydrochloride 2%; Drug: Propofol 1% |
| Group P (Propofol Alone) | Placebo comparator | Participants receive 5 mL of 0.9% sodium chloride before induction, followed by propofol 1% 2-3 mg/kg over 30 seconds without additives. Receives: Drug: Propofol 1%; Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recall of propofol injection pain
Proportion of participants who report remembering pain at the injection site during propofol injection, assessed by asking each participant once after adequate postoperative recovery. Compared between Group M (midazolam + propofol), Group L (lidocaine-propofol mixture), and Group P (propofol alone).
Measured: Postoperative period on the day of surgery, after recovery from anesthesia 30 minutes after arrival in the post-anesthesia care unit (PACU)
Secondary outcomes (2)
Severity of propofol injection pain
Severity of pain during propofol injection graded by the investigator on a 4-point scale (1: no pain; 2: mild arm withdrawal; 3: marked arm withdrawal; 4: verbal expression of pain). Higher scores indicate more pain. Compared between the three groups.
Measured: At the Baseline, During propofol administration (at the time of injection, )
Relationship between preoperative anxiety and propofol injection pain
Preoperative anxiety is measured with a 0-10 Visual Analog Scale (higher scores indicate more anxiety). The relationship between the anxiety score and propofol injection pain score is assessed with Spearman correlation.
Measured: During propofol injection and 30 minutes after arrival in the post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Propofol Injection PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ergun Gunduz, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912567
- Sponsor's protocol ID
- MID001
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Participant data are coded and stored securely, and only de-identified aggregate results will be reported in publications.
Publications
Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
PubMed 15567810Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
PubMed 21455088Boku A, Inoue M, Hanamoto H, Oyamaguchi A, Kudo C, Sugimura M, Niwa H. Effective Dosage of Midazolam to Erase the Memory of Vascular Pain During Propofol Administration. Anesth Prog. 2016 Fall;63(3):147-55. doi: 10.2344/15-00034.1.
PubMed 27585418Bellouni G, Clanet M, Touihri K, Delaporte A, Boulos NM, Kim K, Grogan T, Alexander B, Coeckelenbergh S, Joosten A. Incidence and predictors of postoperative recall of propofol injection pain: a prospective observational cohort pilot study. BJA Open. 2026 Feb 27;17:100537. doi: 10.1016/j.bjao.2026.100537. eCollection 2026 Mar.
PubMed 41798321
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Midazolam Administered at Induction on the Recall of Propofol Injection Pain: A Prospective, Randomized, Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07912567
- Acronym / sponsor ID
- MID001
- Keywords
- Midazolam, Propofol, Lidocaine, Injection Pain, Anterograde Amnesia, Anesthesia Induction, Recall, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Propofol is the most commonly used intravenous drug to start general anesthesia (induction). However, it often causes pain in the arm during injection, and remembering this pain after surgery can negatively affect the patient's experience and comfort. Adding lidocaine (a local anesthetic) to propofol reduces this pain but does not prevent it in every patient. Midazolam is a medicine commonly given to reduce anxiety, and it can also reduce the memory of events that occur after it is given (anterograde amnesia). It is not known whether midazolam reduces the memory of propofol injection pain after surgery.
In this study, adult volunteers aged 18 to 65 who are scheduled for elective surgery will be randomly assigned to one of three groups: (1) a low sedative dose of midazolam before propofol, (2) propofol mixed with lidocaine, or (3) propofol alone. Neither the participants nor the investigator giving the medication will know which group a participant is in. After surgery, once participants have recovered sufficiently, they will be asked whether they remember pain at the injection site during propofol injection. The study will also assess the severity of injection pain and the relationship between anxiety before surgery and injection pain.
All drugs used in this study are approved medicines given at doses used in routine anesthesia practice.
Detailed description
Rationale: Propofol injection pain is common, and recalling it after surgery negatively affects patient experience and comfort. Adding lidocaine to propofol reduces injection pain but is not effective in all patients. Midazolam produces marked anterograde amnesia, but its effect on the postoperative recall of propofol injection pain is not well established. This study aims to separate the independent amnestic effect of midazolam on recall of injection pain from the indirect effect of lidocaine on pain intensity.
Procedures: Eligible participants are screened before surgery, written informed consent is obtained, and preoperative anxiety is measured with a 0-10 Visual Analog Scale (VAS). Participants are randomized 1:1:1 using computer-generated block randomization (variable block sizes of 6 and 9). Allocation concealment is ensured with opaque, sequentially numbered envelopes. An anesthesia technician who is not involved in the assessments opens the envelope and prepares and labels freshly prepared, coded syringes for each participant. The investigator administering the study medication and the participant remain blinded to group allocation until the evaluation is complete. All participants are monitored with ECG, pulse oximetry, and non-invasive blood pressure.Sedation level before induction is assessed with the Ramsay Sedation Scale. Propofol injection pain during induction is graded by the investigator on a 4-point scale (1: no pain; 2: mild arm withdrawal; 3: marked arm withdrawal; 4: verbal expression of pain). In the recovery unit, adequate recovery is determined using the Modified Aldrete Score. After adequate recovery, participants are asked whether they remember pain at the injection site during propofol injection.
Safety: Emergency intubation and resuscitation equipment, flumazenil (midazolam antidote), atropine, epinephrine, and corticosteroids/antihistamines are kept immediately available. The technician who prepared the study solution remains next to the blinded investigator during administration to disclose the contents and dose if an emergency occurs. There is no independent data monitoring committee.
Statistical analysis: Analyses are performed with IBM SPSS Statistics version 24. Recall rates and pain incidence are compared between groups with the chi-square test (Fisher's exact test when required); pain severity is compared with the Kruskal-Wallis test; continuous variables are compared with one-way ANOVA or Kruskal-Wallis depending on distribution. The relationship between preoperative anxiety and injection pain is assessed with Spearman correlation. Sample size was calculated with G*Power 3.1.9.7 (80% power, two-sided alpha 0.05); 45 participants per group were required, and 50 per group (150 total) were planned to allow for dropouts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group M (Midazolam + Propofol) | Experimental | Drug: Midazolam, Drug: Propofol 1%Participants receive midazolam at an age-adjusted sedative dose, diluted with 0.9% sodium chloride to 5 mL, before induction, followed by propofol 1% 2-3 mg/kg over 30 seconds. |
| Group L (Lidocaine-Propofol Mixture) | Active comparator | Drug: Lidocaine Hydrochloride 2%, Drug: Propofol 1%Participants receive 5 mL of 0.9% sodium chloride before induction, followed by a mixture of propofol 1% and lidocaine 2% (200 mg propofol with 40 mg lidocaine) at 2-3 mg/kg propofol over 30 seconds. |
| Group P (Propofol Alone) | Placebo comparator | Drug: Propofol 1%, Drug: Sodium Chloride 0.9%Participants receive 5 mL of 0.9% sodium chloride before induction, followed by propofol 1% 2-3 mg/kg over 30 seconds without additives. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provided written informed consent
- Scheduled for elective surgery
- American Society of Anesthesiologists (ASA) physical status I-II
- Aged 18 to 65 years
- Body mass index (BMI) < 30 kg/m2
Key exclusion criteria (9 listed)
- Chronic pain disorder lasting longer than three months
- Use of gabapentin or similar neuropathic pain medications
- Opioid dependence
- Development of a surgery-related complication during or after the operation
- Liver or kidney failure
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 |
|---|---|---|
| MidazolamAlso: ZolamidSingle intravenous dose of midazolam at an age-adjusted sedative dose (0.06 mg/kg for ages 18-30, 0.05 mg/kg for ages 31-50, 0.04 mg/kg for ages 51-65), diluted with 0.9% sodium chloride to a total volume of 5 mL and given before induction of anesthesia with propofol. | Drug | Group M (Midazolam + Propofol) |
| Lidocaine Hydrochloride 2%Also: LidonLidocaine 2% (total 40 mg) mixed in the same syringe with propofol 1% (200 mg propofol : 40 mg lidocaine) and given intravenously as a single dose during induction. | Drug | Group L (Lidocaine-Propofol Mixture) |
| Propofol 1%Also: Propofol-PFPropofol 1% (10 mg/mL), 2-3 mg/kg administered intravenously over 30 seconds through a 20 G dorsal hand vein catheter as the standard induction agent in all groups. | Drug | Group L (Lidocaine-Propofol Mixture), Group M (Midazolam + Propofol), Group P (Propofol Alone) |
| Sodium Chloride 0.9%Also: Normal saline5 mL of 0.9% sodium chloride given intravenously before propofol induction as a carrier/placebo solution to maintain blinding. | Drug | Group P (Propofol Alone) |
Primary outcome
Postoperative recall of propofol injection pain
Time frame: Postoperative period on the day of surgery, after recovery from anesthesia 30 minutes after arrival in the post-anesthesia care unit (PACU)
Proportion of participants who report remembering pain at the injection site during propofol injection, assessed by asking each participant once after adequate postoperative recovery. Compared between Group M (midazolam + propofol), Group L (lidocaine-propofol mixture), and Group P (propofol alone).
2 secondary outcomes
Severity of propofol injection pain
Time frame: At the Baseline, During propofol administration (at the time of injection, )
Relationship between preoperative anxiety and propofol injection pain
Time frame: During propofol injection and 30 minutes after arrival in the post-anesthesia care unit (PACU)
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 3 Nov 2026.
- Background: PubMed 15567810Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
- Background: PubMed 21455088Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.
- Background: PubMed 27585418Boku A, Inoue M, Hanamoto H, Oyamaguchi A, Kudo C, Sugimura M, Niwa H. Effective Dosage of Midazolam to Erase the Memory of Vascular Pain During Propofol Administration. Anesth Prog. 2016 Fall;63(3):147-55. doi: 10.2344/15-00034.1.
- Background: PubMed 41798321Bellouni G, Clanet M, Touihri K, Delaporte A, Boulos NM, Kim K, Grogan T, Alexander B, Coeckelenbergh S, Joosten A. Incidence and predictors of postoperative recall of propofol injection pain: a prospective observational cohort pilot study. BJA Open. 2026 Feb 27;17:100537. doi: 10.1016/j.bjao.2026.100537. eCollection 2026 Mar.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Participant data are coded and stored securely, and only de-identified aggregate results will be reported in publications.
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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.
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 Midazolam, Lidocaine Hydrochloride 2% and Propofol 1% in people with Propofol Injection Pain and Postoperative Recall of Pain, run by Atlas 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 7 inclusion and 9 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 3 Nov 2026. 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?
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 Ergun Gunduz, MD, PhD (+90 5327449021, ergun.gunduz@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recall of propofol injection pain (time frame: Postoperative period on the day of surgery, after recovery from anesthesia 30 minutes after arrival in the post-anesthesia care unit (PACU)). 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 NCT07912567, which also lists 4 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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.