Sedation Methods for Cataract Surgery
(CaTNAPS-1 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Benzodiazepines
Disqualifiers: Prior cataract surgery, Severe anxiety, Cardiac conditions, Morbid obesity, others
Trial Summary
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.
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.
12345Is 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.
35678How 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.
35689Eligibility 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.
+4 more
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.
+13 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Oral sedation will be administered to patients prior to the procedure.
Group II: PlaceboPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Institutes of Health (NIH)Collaborator
National Institute on Aging (NIA)Collaborator
References
Effect of intravenous sedation on patients' visual experience and vital signs during cataract surgery under topical anesthesia: A randomized controlled trial. [2023]Effect of intravenous sedation on patients' visual experience and vital signs during cataract surgery under topical anesthesia: a randomized controlled trial.
Patient Satisfaction with Oral versus Intravenous Sedation for Cataract Surgery: A Randomized Clinical Trial. [2020]To determine whether patient satisfaction with oral sedation is noninferior to intravenous sedation for cataract surgery.
Monitored anesthesia care. [2022]According to the American Society of Anesthe-siologists (ASA), a monitored anesthesia care (MAC) is a planned procedure during which the patient undergoes local anesthesia together with sedation and analgesia. Actually MAC is the first choice in 10-30% of all the surgical procedures. The 3 fundamental elements and purposes of a conscious sedation during a MAC are: a safe sedation, the control of the patient anxiety and the pain control. The patients undergoing conscious sedation are able to answer to orders appropriately and to protect airways. Last but not least, another purpose of any MAC is to get the patient appropriately satisfied, allowing him to get his discharge as faster as possible. There are many surgical procedures which can be performed using a MAC. The patient consciousness evaluation is of extreme importance during the surgical procedure performed with MAC: to this purpose the clinical and electroencephalographic evaluations such as Bispectral Index are very useful. MAC can be obtained with the association of fast half-life drugs or drugs getting a clinical effect which can vary according to the surgical requirements, using an infusion regiment. Apart from the pharmacological choice, this procedure can be performed with patient controlled sedation techniques or with continued intravenous infusion or with target controlled infusion.
Local anesthesia for cataract surgery. [2010]Various aspects of local anesthesia for cataract surgery, such as the anesthetic agents and their interaction with ocular nerve supply, anesthesia requirements, available clinical techniques and their inherent complications are reviewed. A comparative evaluation of clinical techniques in terms of efficacy, akinesia, and patient-perceived pain during both anesthesia administration and intraoperative cataract surgery is presented, along with the prevailing practice patterns of anesthesia techniques among refractive surgeons in the United Kingdom and United States. More randomized clinical trials are needed to facilitate statistical methods of metaanalysis to establish convincingly the overall benefits and efficacy of the various local anesthesia procedures in cataract surgery. The wide scope of the present review is of relevance in structuring ophthalmology and anesthesia specialist training programs for junior staff.
Monitored anaesthesia care (MAC) and ophthalmic surgery. [2019]The use of monitored anaesthesia care (MAC) is increasing with the discovery of newer, more effective and appropriate drugs and techniques. MAC is intended to achieve patient comfort with safety and optimal clinical outcome and is being extensively used worldwide for cataract and other ophthalmic surgeries. This article briefly reviews the conceptual basis of MAC, its use in ophthalmic surgeries, sedative-analgesic drugs commonly used during MAC in eye surgeries, monitoring during MAC in eye surgery and the role of anaesthesia practitioners during MAC.
Analysis of urgent/emergent conversions from monitored anesthesia care to general anesthesia with airway instrumentation. [2022]Monitored Anesthesia Care (MAC) is an anesthetic service involving the titration of sedatives/analgesics to achieve varying levels of sedation while avoiding general anesthesia (GA) and airway instrumentation. The goal of our study was to determine the overall incidence of conversion from MAC to general anesthesia with airway instrumentation and elucidate reasons and risk factors for conversion.
Patient-controlled propofol sedation for elderly patients: safety and patient attitude toward control. [2018]Little information is available regarding the use of patient-controlled sedation (PCS) among elderly patients undergoing operative procedures under local or regional anaesthesia. This prospective, randomized study evaluated the safety of propofol PCS, and the attitude among elderly patients toward self-administration of sedation during cataract surgery.
Monitored anesthesia care in and outside the operating room. [2022]Monitored anesthesia care (MAC) is an anesthesia technique combining local anesthesia with parenteral drugs for sedation and analgesia. The use of MAC is increasing for a variety of diagnostic and therapeutic procedures in and outside of the operating room due to the rapid postoperative recovery with the use of relatively small amounts of sedatives and analgesics compared to general anesthesia. The purposes of MAC are providing patients with safe sedation, comfort, pain control and satisfaction. Preoperative evaluation for patients with MAC is similar to those of general or regional anesthesia in that patients should be comprehensively assessed. Additionally, patient cooperation with comprehension of the procedure is an essential component during MAC. In addition to local anesthesia by operators or anesthesiologists, systemic sedatives and analgesics are administered to provide patients with comfort during procedures performed with MAC. The discretion and judgment of an experienced anesthesiologist are required for the safety and efficacy profiles because the airway of the patients is not secured. The infusion of sedatives and analgesics should be individualized during MAC. Many procedures in and outside of the operating room, including eye surgery, otolaryngologic surgery, cardiovascular procedures, pain procedures, and endoscopy are performed with MAC to increase patient and operator satisfaction.
Practical Considerations for Dexmedetomidine Sedation in Adult Cataract Surgery Under Local/Regional Anesthesia: A Narrative Review. [2021]Cataract surgery is predominantly performed under local/regional anesthesia, with or without sedation. The practice pattern of sedation is unknown and seems to vary significantly among institutions and countries, routinely administered in some parts of the world to the other extreme of none at all. The selection of sedative agents and techniques varies widely. Currently, there is no ideal sedative agent. Dexmedetomidine has gained recent attention for sedation in ophthalmic local/regional anesthesia due to its alleged advantages of effective sedation with minimal respiratory depression, decreased intraocular pressure, and reduced pain during the local anesthetic injection; however, they are subject to differing interpretations. Published literature also suggests that although dexmedetomidine sedation for cataract surgery under local/regional anesthesia is potentially useful, its role may be limited due to logistical difficulties in administering the recommended dose.