Sedation Methods for Cataract Surgery

(CaTNAPS-1 Trial)

Overseen By Jacob A Flores, M.P.H

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Benzodiazepines

Disqualifiers: Prior cataract surgery, Severe anxiety, Cardiac conditions, Morbid obesity, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to help people relax during cataract surgery. One group receives oral sedation (a pill that aids sedation), while the other receives a placebo (a pill with no active ingredients). The researchers aim to determine which method enhances patient satisfaction, aids recovery, and performs well during surgery. This trial suits individuals newly diagnosed with cataracts who plan to undergo surgery within the next six months, provided they can climb a flight of stairs without stopping and have not had cataract surgery before. Participants will share their experiences through surveys to assist in planning a larger future study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient care during cataract surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have severe anxiety requiring routine use of benzodiazepines, you may not be eligible to participate.

What prior data suggests that these sedation methods are safe for cataract surgery?

Research shows that taking a sedative pill by mouth is generally safe and well-received for cataract surgery. Studies have found that patients usually express satisfaction with this method, giving it an average score of 5.23 out of 6. This indicates that people find it comfortable and effective compared to other sedation methods. Although these studies report no specific negative side effects, the regular use of oral sedation in cataract surgeries suggests it is safe for many people.

The trial also includes a placebo group, meaning some participants will receive a harmless pill without sedative effects. This allows researchers to compare the effects of the sedative pill to no sedation at all.

Overall, the evidence suggests that taking a sedative pill is a safe choice for this type of surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores oral sedation as a method for cataract surgery, which could offer a more patient-friendly alternative to current approaches like intravenous sedation or local anesthesia with intravenous supplementation. Oral sedation is less invasive, potentially reducing pre-surgery anxiety without the need for needles or complex monitoring. Additionally, this method could streamline the surgical process, making it more accessible and comfortable for patients. If effective, oral sedation might become a simpler and more convenient option for those undergoing cataract surgery.

What evidence suggests that these sedation methods are effective for cataract surgery?

This trial will compare oral sedation with a placebo for cataract surgery. Research has shown that taking a sedative pill for cataract surgery can be effective. In one study, patients who took a sedative pill felt as satisfied as those using more common sedation methods. Additionally, the need for assistance from anesthesia staff decreased, allowing the surgery to proceed smoothly without extra help. This suggests that a sedative pill can provide a good balance of comfort and effectiveness during cataract surgery. Overall, evidence supports this as a viable option for patients considering cataract surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Catherine L Chen, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals undergoing cataract surgery, specifically those with senile cataracts. Participants should be interested in contributing to research on sedation methods and willing to complete surveys about their experience.

Inclusion Criteria

I can follow instructions.

Capable of providing informed consent and completing the study procedures in English

I am 65 years old or older.

Exclusion Criteria

I have chest pain or angina that hasn't been treated.

I have had cataract surgery in the past.

I need oxygen at home, either all the time or when I move around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral sedation or an oral placebo prior to cataract surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of surveys on patient satisfaction and quality of recovery

4 weeks

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Oral sedation
• Placebo

Trial Overview The study compares two sedation approaches during cataract surgery: one group receives a placebo while the other gets oral sedation. The focus is on patient satisfaction, recovery quality, and surgical outcomes.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Oral sedation will be administered to patients prior to the procedure.

Group II: Placebo Placebo Group 1 Intervention

An oral placebo pill will be administered to patients prior to the procedure.

Oral sedation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Oral Sedation for:

• Cataract surgery
• Dental procedures
• Endoscopy
• Bronchoscopy
• Pain management procedures

Approved in European Union as Conscious Sedation for:

• Cataract surgery
• Ophthalmic surgery
• Gastrointestinal endoscopic procedures
• Dental surgery

Approved in Canada as Monitored Anesthesia Care (MAC) for:

• Cataract surgery
• Eye surgery
• Neurosurgery
• Cardiovascular surgery

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Monitored Anesthesia Care (MAC) is a preferred option for 10-30% of surgical procedures, providing local anesthesia along with sedation and pain control, ensuring patient safety and comfort during surgery.

The effectiveness of MAC relies on careful monitoring of patient consciousness, using tools like the Bispectral Index, and can be achieved through various drug delivery methods, allowing for tailored sedation based on surgical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored anesthesia care. Ghisi, D., Fanelli, A., Tosi, M., et al.[2022]

Monitored anaesthesia care (MAC) is becoming more popular in ophthalmic surgeries, such as cataract procedures, due to advancements in safer and more effective drugs and techniques.

MAC aims to enhance patient comfort while ensuring safety and optimal clinical outcomes, highlighting the important role of anaesthesia practitioners in monitoring and administering care during these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored anaesthesia care (MAC) and ophthalmic surgery. Bhattarai, BK.[2019]

Monitored anesthesia care (MAC) combines local anesthesia with sedation and analgesia, leading to faster recovery and increased patient comfort compared to general anesthesia, making it suitable for various procedures.

The safety and efficacy of MAC depend on the careful assessment and individualized administration of sedatives by experienced anesthesiologists, as patient cooperation and airway management are critical during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored anesthesia care in and outside the operating room. Sohn, HM., Ryu, JH.[2022]

In a study of over 219,000 patients receiving Monitored Anesthesia Care (MAC), only 0.50% were converted to general anesthesia (GA), indicating that MAC is generally safe and effective for most patients.

The main reasons for conversion included patient intolerance to MAC and physiological issues, with specific risk factors identified such as higher body mass index, male sex, and certain surgical specialties, which can help in anticipating and preventing conversions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of urgent/emergent conversions from monitored anesthesia care to general anesthesia with airway instrumentation. Kim, S., Chang, BA., Rahman, A., et al.[2022]

Intravenous sedation with midazolam during cataract surgery significantly reduces patients' awareness of the procedure, fear, and unpleasant experiences compared to a control group, leading to a more comfortable surgical experience.

Patients receiving midazolam also exhibited less fluctuation in mean arterial pressure (MAP) during surgery, indicating better cardiovascular stability, especially in those with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intravenous sedation on patients' visual experience and vital signs during cataract surgery under topical anesthesia: A randomized controlled trial. Venkatesh, R., Kenia, H., Sengupta, S., et al.[2023]

A study involving 85 patients showed that oral sedation with triazolam for cataract surgery resulted in patient satisfaction scores that were noninferior to those achieved with intravenous sedation using midazolam, indicating that oral sedation is a viable alternative.

Both sedation methods had similar levels of satisfaction among surgeons and anesthesia providers, and while there were slightly more intraoperative complications in the oral group, the difference was not statistically significant, suggesting that oral sedation is a safe option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction with Oral versus Intravenous Sedation for Cataract Surgery: A Randomized Clinical Trial. Peeler, CE., Villani, CM., Fiorello, MG., et al.[2020]

The review highlights the need for more randomized clinical trials to better evaluate the efficacy and safety of different local anesthesia techniques used in cataract surgery, as current evidence is insufficient for strong conclusions.

It emphasizes the importance of understanding various anesthetic agents and their effects on ocular nerve supply, which can influence patient pain perception and overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthesia for cataract surgery. Malik, A., Fletcher, EC., Chong, V., et al.[2010]

Dexmedetomidine is gaining attention as a sedative for cataract surgery under local anesthesia due to its potential benefits, including effective sedation with minimal respiratory depression and reduced pain during injections.

Despite its advantages, the use of dexmedetomidine may be limited by logistical challenges in administering the recommended doses, highlighting the need for further evaluation of its practical application in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Considerations for Dexmedetomidine Sedation in Adult Cataract Surgery Under Local/Regional Anesthesia: A Narrative Review. Kumar, CM., Chua, AWY., Imani, F., et al.[2021]

In a study of 55 elderly patients undergoing cataract surgery, propofol patient-controlled sedation (PCS) was found to be a safe and effective option, with no significant differences in intraoperative complications compared to those who did not receive sedation.

Patient satisfaction was notably higher in the PCS group, with many patients appreciating the ability to control their sedation, indicating a positive attitude towards self-administration during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled propofol sedation for elderly patients: safety and patient attitude toward control. Herrick, IA., Gelb, AW., Nichols, B., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12212095/

Patient Perspectives and Concerns Regarding Cataract ... Patients prefer anesthesia-led sedation for cataract surgery but are willing to consider alternatives to MAC if the published evidence and their ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06506669

Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot ... The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06506669

Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot ... The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0161642099007058

Effectiveness of monitored anesthesia care in cataract ... Our study demonstrated that intervention by anesthesia personnel was required in 37.4% of patients who underwent consecutive cataract surgery and received ...

5. withpower.com withpower.com/trial/phase-cataract-5-2024-3c456

Sedation Methods for Cataract Surgery (CaTNAPS-1 Trial) A study involving 85 patients showed that oral sedation with triazolam for cataract surgery resulted in patient satisfaction scores that were noninferior to ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2797100

Anesthesia Care for Cataract Surgery in Medicare ... Anesthesia care was more common among Medicare beneficiaries undergoing cataract surgery compared with other low-risk procedures (89.8% vs <1% to 70.2%).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293940101159X

A decision analysis of anesthesia management for cataract ... CONCLUSION: This analysis emphasizes that cost and preference are important considerations when choosing an anesthesia management strategy for cataract surgery.

8. dovepress.com dovepress.com/long-term-satisfaction-of-oral-sedation-versus-standard-of-care-intrav-peer-reviewed-fulltext-article-OPTH

Long-term Satisfaction of Oral Versus Intravenous Sedation The follow-up mean satisfaction score was 5.23 ± 0.90 for oral sedation and 5.60 ± 0.61 for IV sedation, with a difference in the mean ...