Oral vs IV Sedation for Cataract Surgery

(CatNAPS-2 Trial)

Overseen By Catherine L Chen, MD, MPH

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Benzodiazepines

Disqualifiers: Prior cataract surgery, Hospital admission, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Day of surgery

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether taking a pill (oral sedation) can help people feel relaxed during cataract surgery as effectively as receiving medicine through a vein (IV sedation). It also evaluates how both methods affect recovery, particularly memory and thinking, and patient satisfaction with care. Participants will receive either a pill (such as Alprazolam) or an IV sedative (such as Midazolam) before surgery and will complete surveys about their recovery. This trial targets individuals 65 or older who have recently been diagnosed with cataracts and plan to undergo surgery soon. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that taking alprazolam (Xanax) orally is a convenient and safe option for cataract surgery. Patients who used alprazolam reported a more comfortable experience with less pain. Another study found no negative effects from using this oral sedation for cataract procedures, indicating it is a safe choice.

For IV sedation with midazolam, studies indicate it effectively reduces pain and anxiety during cataract surgery. However, side effects can include a slow heart rate, high blood pressure, and drowsiness after the surgery. Despite these possible issues, midazolam is commonly used and considered effective for this type of procedure.

Since this trial is in Phase 4, earlier trials have tested both treatments for safety, and they are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing oral and IV sedation options for cataract surgery because each approach offers unique benefits. Oral sedation with alprazolam provides a simpler, needle-free option that might reduce patient anxiety and streamline the preparation process. On the other hand, IV sedation with midazolam allows for rapid adjustment of sedation levels during surgery, offering precise control if additional sedation becomes necessary. Understanding the effectiveness and patient comfort levels with each method could lead to more personalized and efficient care options in cataract surgery.

What evidence suggests that oral and IV sedation could be effective for cataract surgery?

In this trial, participants will be divided into two groups to compare oral and IV sedation for cataract surgery. Previous studies have shown that taking alprazolam orally can make surgery more comfortable by reducing pain. Research also indicates that oral sedation can be as effective as IV sedation for some eye surgeries. Participants in the Oral Sedation Group will receive oral alprazolam. Meanwhile, using an IV with midazolam can significantly reduce fear and visual issues during cataract surgery. Participants in the IV Sedation Group will receive IV midazolam. Both oral alprazolam and IV midazolam have provided similar levels of patient satisfaction. Overall, both options help patients feel relaxed and satisfied during cataract surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Catherine L Chen, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for older adults undergoing cataract surgery who are in good enough health to participate. It aims to compare the effects of oral sedation with a pill versus IV sedation on relaxation during surgery, recovery, and satisfaction with care.

Inclusion Criteria

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

Able to provide consent for oneself

Able to follow directions

Exclusion Criteria

Difficulty being sedated during other minor outpatient procedures or imaging studies

Allergy or resistance to local anesthetic agents

Admission to the hospital within the past 30 days

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 with alprazolam and IV placebo or IV sedation with midazolam and oral placebo prior to cataract surgery

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for cognitive recovery and satisfaction with sedation experience, with follow-up phone calls up to seven days after surgery

7 days

Phone follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Alprazolam
• Midazolam

Trial Overview The study tests whether Midazolam (IV) or Alprazolam (oral), both sedatives, can effectively relax patients during cataract surgery without negatively impacting cognitive function post-surgery. Participants will be randomly given either the pill with an IV placebo or vice versa.

How Is the Trial Designed?

Group I: Oral Sedation Group Experimental Treatment 1 Intervention

Participants in this group will receive oral sedation with alprazolam (0.5 mg) and IV placebo prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.

Group II: IV Sedation Group Active Control 1 Intervention

Participants in this group will receive IV sedation with midazolam (1 mg) and an oral placebo pill prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10577815/

Effect of intravenous sedation on patients' visual experience ... A sedative dose of intravenous midazolam during phacoemulsification under topical anesthesia significantly reduces patients' visual experience, fear and ...

2. msjonline.org msjonline.org/index.php/ijrms/article/view/10310

Assessing intravenous midazolam for conscious sedation ... Results: Patients who were sedated with midazolam prior to cataract surgery along with block exhibited a significant decrease in hemodynamic ...

3. journals.lww.com journals.lww.com/jcrs/fulltext/2025/08000/intravenous_vs_nonintravenous_sedation_for.12.aspx

Intravenous vs nonintravenous sedation for cataract surgery Results showed that IV sedation significantly reduced pain compared to no sedation, but there was no difference in pain relief between IV and oral sedation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642018331750

Patient Satisfaction with Oral versus Intravenous Sedation ... Our findings demonstrate that cataract surgery with oral triazolam is noninferior to intravenous midazolam in terms of patient satisfaction.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jcpt.13715?mi=1typu00&af=R&PubType=journal&content=articlesChapters&field1=Keyword&sortBy=Earliest&target=default&text1=cataract

The impact of midazolam used in cataract surgery sedation ... The study included 177 patients administered midazolam as a sedoanalgesia during cataract surgery. The sedative effect was evaluated 2–3 minutes ...

6. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14845

Peri‐operative considerations for sedation‐analgesia during ... The most recent published data in 2016 showed 4.1% of patients received sedation, 3.4% general anaesthesia and 92.5% local anaesthesia without ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03054103

NCT03054103 | Sedation Methods During Cataract Surgery The purpose of this study was to determine if adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating conditions, patient ...

8. aao.org aao.org/eyenet/article/anesthesiology-in-a-changing-cataract-landscape

Anesthesiology in a Changing Cataract Landscape However, data suggest that risk of bradycardia, hypertensive episodes, postoperative drowsiness, and other adverse events are more associated ...