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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the sedation methods used for cataract surgery?

Research shows that both oral and intravenous sedation can be effective for cataract surgery, with studies indicating that patient satisfaction with oral sedation is comparable to intravenous sedation. Monitored Anesthesia Care (MAC) is also widely used for eye surgeries, providing safe sedation, anxiety control, and pain management, which helps patients recover quickly and be discharged sooner. ^{1 2 3 4 5}

Is monitored anesthesia care (MAC) safe for cataract surgery?

Monitored anesthesia care (MAC) is considered safe for cataract and other eye surgeries, providing comfort and pain control with minimal sedation. It allows patients to remain responsive and recover quickly, with the discretion of an experienced anesthesiologist ensuring safety. ^{3 5 6 7 8}

How does oral sedation differ from other treatments for cataract surgery?

Oral sedation for cataract surgery is unique because it involves taking medication by mouth to help relax the patient, unlike other methods that might use injections or intravenous drugs. This approach can be more convenient and less invasive, providing comfort and anxiety control without the need for more complex anesthesia techniques. ^{3 5 6 8 9}

What is the purpose of this trial?

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol 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.

Research Team

Catherine L Chen, M.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient Satisfaction with Oral versus Intravenous Sedation for Cataract Surgery: A Randomized Clinical Trial. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

Monitored anesthesia care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Local anesthesia for cataract surgery. [2010]

5. Nepal pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Analysis of urgent/emergent conversions from monitored anesthesia care to general anesthesia with airway instrumentation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled propofol sedation for elderly patients: safety and patient attitude toward control. [2018]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Monitored anesthesia care in and outside the operating room. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Practical Considerations for Dexmedetomidine Sedation in Adult Cataract Surgery Under Local/Regional Anesthesia: A Narrative Review. [2021]