CataractCaTNAPS-1NCT06506669
Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
A study testing Oral sedation in people with Cataract and Bilateral Senile Cataract, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes for the purpose of planning a larger clinical trial. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Bilateral Senile Cataract, Anesthesia
- What is being tested?
- Oral sedation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 29 May 2025
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 60 years old
- Capable of providing informed consent and completing the study procedures in English
- Able to provide consent for oneself
- Able to follow directions
- Able to climb one flight of stairs without stopping to rest
- Have a new diagnosis of cataract disease
- Plan on having cataract surgery on their eye within the next 6 months
Who cannot join
- History of prior cataract surgery
- Admission to the hospital within the past 30 days
- Difficulty being sedated during other minor outpatient procedures or imaging studies
- Allergy or resistance to local anesthetic agents
- Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
- History of severe anxiety requiring routine use of benzodiazepines
Show all 16Show fewer
- Severe valve disease (e.g., critical aortic stenosis)
- Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
- Untreated chest pain or angina
- Patients with movement disorders (e.g., Parkinson's Disease)
- History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
- Require home oxygen (O2) at rest or with exertion
- End-stage renal disease (ESRD) requiring dialysis
- Morbid obesity (BMI>35)
- Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
- Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.
Read the detailed description
This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, quality of recovery, and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.
- Conditions
- Cataract, Bilateral Senile Cataract, Anesthesia, Patient Satisfaction
- Being tested
- Oral sedation, Placebo
- Keywords
- cataract surgery, oral sedation, intravenous sedation, conscious sedation, monitored anesthesia care, quality of recovery
- Medical subject headings
- Cataract, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sedationProcedure or surgery
Oral medication for anxiolysis administered in the preoperative setting
PlaceboProcedure or surgery
A placebo pill with no active ingredients administered in the preoperative setting
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oral sedation will be administered to patients prior to the procedure. Receives: Procedure: Oral sedation |
| Placebo | Placebo comparator | An oral placebo pill will be administered to patients prior to the procedure. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With High Satisfaction (ISAS Score ≥ 2)
The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction.
For this analysis, high satisfaction is defined as an ISAS score ≥ 2.
Measured: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Secondary outcomes (7)
Number of Participants Meeting Eligibility Criteria at Screening
Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility
Measured: At screening (prior to enrollment)
Number of Participants Completing All Study Surveys at Each Timepoint
Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm
Measured: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Number of Participants Who Completed All Required Study Procedures
Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study
Instruments:
Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI)
Measured: From enrollment through final study follow-up (POD7)
Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study
Measured: From enrollment through 30 days after surgery
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains.
For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point.
Measured: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Quality of Recovery-15 (QoR-15) Total Score After Surgery
The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence. Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150. Higher scores indicate better recovery.
Measured: 1 day and 7 days after surgery
Functional Recovery Index (FRI) Total Score After Surgery
The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living. Each item is scored and summed to produce a total score ranging from 0 to 100. Lower scores indicate better functional recovery.
Measured: 1 day and 7 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 posted17 Jul 2024
- Study start12 Jun 2024
- Primary completion6 May 2025
- Study completion29 May 2025
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 (51)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, double-blinded, randomized pilot clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Catherine L Chen, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506669
- Sponsor's protocol ID
- 23-40367
- Other IDs
- 5K23AG072035-03
- Acronym
- CaTNAPS-1
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2024
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small single center pilot study so we do not plan to make individual participant data available to other researchers.
Publications
Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.
PubMed 25875258Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372.
PubMed 29346472Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
PubMed 28242111Norregaard, J. C. Results from the International Cataract Surgery Outcomes Study. Acta Ophthalmologica Scandinavica 85, 5-32, doi:10.1111/j.1600-0420.2007.00937.x (2007).
Kent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).
Andrews, M. Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery, <https://khn.org/news/anthem-calls-on-eye-surgeons-to-monitor-anesthesia-during-cataract-surgery/> (2018).
Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.
PubMed 26804760Zakrzewski PA, Friel T, Fox G, Braga-Mele R. Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases. Ophthalmology. 2005 Feb;112(2):272-7. doi: 10.1016/j.ophtha.2004.08.016.
PubMed 15691563Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. Clin Exp Ophthalmol. 2007 Aug;35(6):589. doi: 10.1111/j.1442-9071.2007.01553.x. No abstract available.
PubMed 17760646Murray P, Adams K, Haddad P, Murray N, O'Rourke M. The routine requirement for anaesthetists in local anaesthetic cataract surgery. Clin Exp Ophthalmol. 2007 Mar;35(2):195-6. doi: 10.1111/j.1442-9071.2006.01441.x. No abstract available.
PubMed 17362468Zakrzewski PA, Banashkevich AV, Friel T, Braga-Mele R. Monitored anesthesia care by registered respiratory therapists during cataract surgery: an update. Ophthalmology. 2010 May;117(5):897-902. doi: 10.1016/j.ophtha.2009.10.005. Epub 2010 Jan 15.
PubMed 20079927Basta B, Gioia L, Gemma M, Dedola E, Bianchi I, Fasce F, Beretta L. Systemic adverse events during 2005 phacoemulsifications under monitored anesthesia care: a prospective evaluation. Minerva Anestesiol. 2011 Sep;77(9):877-83.
PubMed 21878869Koolwijk J, Fick M, Selles C, Turgut G, Noordergraaf JI, Tukkers FS, Noordergraaf GJ. Outpatient cataract surgery: incident and procedural risk analysis do not support current clinical ophthalmology guidelines. Ophthalmology. 2015 Feb;122(2):281-7. doi: 10.1016/j.ophtha.2014.08.030. Epub 2014 Oct 22.
PubMed 25444350Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD. Injectable versus topical anesthesia for cataract surgery: patient perceptions of pain and side effects. The Study of Medical Testing for Cataract Surgery study team. Ophthalmology. 2000 Nov;107(11):2054-60. doi: 10.1016/s0161-6420(00)00359-6.
PubMed 11054331Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD; Study of Medical Testing for Cataract Surgery Study Team. Adverse intraoperative medical events and their association with anesthesia management strategies in cataract surgery. Ophthalmology. 2001 Oct;108(10):1721-6. doi: 10.1016/s0161-6420(01)00704-7.
PubMed 11581040
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT06506669
- Acronym / sponsor ID
- CaTNAPS-1 / 23-40367
- Conditions
- Cataract, Bilateral Senile Cataract, Anesthesia, Patient Satisfaction
- Keywords
- cataract surgery, oral sedation, intravenous sedation, conscious sedation, monitored anesthesia care, quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.
Detailed description
This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, quality of recovery, and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, randomized, double-blinded, randomized pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Oral sedationOral sedation will be administered to patients prior to the procedure. |
| Placebo | Placebo comparator | Procedure: PlaceboAn oral placebo pill will be administered to patients prior to the procedure. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 60 years old
- Capable of providing informed consent and completing the study procedures in English
- Able to provide consent for oneself
- Able to follow directions
- Able to climb one flight of stairs without stopping to rest
Key exclusion criteria (16 listed)
- History of prior cataract surgery
- Admission to the hospital within the past 30 days
- Difficulty being sedated during other minor outpatient procedures or imaging studies
- Allergy or resistance to local anesthetic agents
- Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
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 |
|---|---|---|
| Oral sedationOral medication for anxiolysis administered in the preoperative setting | Procedure or surgery | Intervention |
| PlaceboA placebo pill with no active ingredients administered in the preoperative setting | Procedure or surgery | Placebo |
Primary outcome
Number of Participants With High Satisfaction (ISAS Score ≥ 2)
Time frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2.
7 secondary outcomes
Number of Participants Meeting Eligibility Criteria at Screening
Time frame: At screening (prior to enrollment)
Number of Participants Completing All Study Surveys at Each Timepoint
Time frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Number of Participants Who Completed All Required Study Procedures
Time frame: From enrollment through final study follow-up (POD7)
Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
Time frame: From enrollment through 30 days after surgery
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
Time frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
Quality of Recovery-15 (QoR-15) Total Score After Surgery
Time frame: 1 day and 7 days after surgery
Functional Recovery Index (FRI) Total Score After Surgery
Time frame: 1 day and 7 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25875258Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.
- Background: PubMed 29346472Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372.
- Background: PubMed 28242111Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
- BackgroundNorregaard, J. C. Results from the International Cataract Surgery Outcomes Study. Acta Ophthalmologica Scandinavica 85, 5-32, doi:10.1111/j.1600-0420.2007.00937.x (2007).
- BackgroundKent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).
- BackgroundAndrews, M. Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery, <https://khn.org/news/anthem-calls-on-eye-surgeons-to-monitor-anesthesia-during-cataract-surgery/> (2018).
- Background: PubMed 26804760Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.
- Background: PubMed 15691563Zakrzewski PA, Friel T, Fox G, Braga-Mele R. Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases. Ophthalmology. 2005 Feb;112(2):272-7. doi: 10.1016/j.ophtha.2004.08.016.
- Background: PubMed 17760646Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. Clin Exp Ophthalmol. 2007 Aug;35(6):589. doi: 10.1111/j.1442-9071.2007.01553.x. No abstract available.
- Background: PubMed 17362468Murray P, Adams K, Haddad P, Murray N, O'Rourke M. The routine requirement for anaesthetists in local anaesthetic cataract surgery. Clin Exp Ophthalmol. 2007 Mar;35(2):195-6. doi: 10.1111/j.1442-9071.2006.01441.x. No abstract available.
- Background: PubMed 20079927Zakrzewski PA, Banashkevich AV, Friel T, Braga-Mele R. Monitored anesthesia care by registered respiratory therapists during cataract surgery: an update. Ophthalmology. 2010 May;117(5):897-902. doi: 10.1016/j.ophtha.2009.10.005. Epub 2010 Jan 15.
- Background: PubMed 21878869Basta B, Gioia L, Gemma M, Dedola E, Bianchi I, Fasce F, Beretta L. Systemic adverse events during 2005 phacoemulsifications under monitored anesthesia care: a prospective evaluation. Minerva Anestesiol. 2011 Sep;77(9):877-83.
- Individual participant dataSharing planned: No. This is a small single center pilot study so we do not plan to make individual participant data available to other researchers.
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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.
Catherine L Chen, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral sedation in people with Cataract and Bilateral Senile Cataract, run by University of California, San Francisco at 1 site in United States.
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 16 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 9 Jul 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). 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?
Number of Participants With High Satisfaction (ISAS Score ≥ 2) (time frame: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)). 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 NCT06506669, which also lists 51 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 9 Jul 2026.