Trial Outcomes & Findings for Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study (NCT NCT06506669)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Results posted on

2026-07-09

Participant Flow

Recruitment occurred during the study period at UCSF-affiliated outpatient ophthalmology surgical sites. Eligible adults scheduled for elective cataract surgery were identified through surgical schedules and preoperative records. Study staff contacted patients by phone prior to surgery to screen eligibility, describe the study, and obtain informed consent.

No washout or run-in procedures occurred between enrollment and assignment. After enrollment, participants completed baseline assessments and eligibility confirmation prior to day-of-surgery randomization. Participants who did not proceed to surgery as scheduled or withdrew consent before surgery were not assigned to a study arm.

Participant milestones

Participant milestones
Measure	Intervention Oral sedation will be administered to patients prior to the procedure.	Placebo An oral placebo pill will be administered to patients prior to the procedure.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Total n=20 Participants Total of all reporting groups
Race (NIH/OMB) Asian	1 Participants n=20 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Age, Categorical >=65 years	9 Participants n=20 Participants	10 Participants n=20 Participants	19 Participants n=40 Participants
Sex: Female, Male Female	6 Participants n=20 Participants	4 Participants n=20 Participants	10 Participants n=40 Participants
Sex: Female, Male Male	4 Participants n=20 Participants	6 Participants n=20 Participants	10 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) White	9 Participants n=20 Participants	5 Participants n=20 Participants	14 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants

PRIMARY outcome

Timeframe: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Population: All randomized participants were included in the analysis at each timepoint (N=20). For participants with missing ISAS responses, values were imputed using a permutation-based approach to preserve the overall distribution of observed responses within each study arm. As a result, the number analyzed remains constant across timepoints and matches the number of participants assigned to each arm.

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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall n=20 Participants All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants With High Satisfaction (ISAS Score ≥ 2) POD1	4 Participants	9 Participants	13 Participants
Number of Participants With High Satisfaction (ISAS Score ≥ 2) PACU	6 Participants	7 Participants	13 Participants
Number of Participants With High Satisfaction (ISAS Score ≥ 2) POD7	6 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: At screening (prior to enrollment)

Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants Meeting Eligibility Criteria at Screening	10 Participants	10 Participants	—

SECONDARY outcome

Timeframe: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

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

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants Completing All Study Surveys at Each Timepoint POD7	10 Participants	10 Participants	—
Number of Participants Completing All Study Surveys at Each Timepoint PACU	10 Participants	10 Participants	—
Number of Participants Completing All Study Surveys at Each Timepoint POD1	10 Participants	10 Participants	—

SECONDARY outcome

Timeframe: From enrollment through final study follow-up (POD7)

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)

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants Who Completed All Required Study Procedures PQRS	9 Participants	10 Participants	—
Number of Participants Who Completed All Required Study Procedures ISAS	10 Participants	10 Participants	—
Number of Participants Who Completed All Required Study Procedures FRI	10 Participants	10 Participants	—
Number of Participants Who Completed All Required Study Procedures QoR-15	10 Participants	10 Participants	—

SECONDARY outcome

Timeframe: From enrollment through 30 days after surgery

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

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)

Population: Analyses include participants with available PQRS data at each time point. Participants with missing PQRS assessments were excluded from that timepoint-specific analysis. As a result, the number analyzed varies by time point and by study arm. The overall group reflects the total number of participants with available data across both arms at each time point.

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.

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall n=19 Participants All study participants who were randomized to receive oral or placebo medication prior to surgery.
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) PACU	3 Participants	3 Participants	6 Participants
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) POD1	3 Participants	5 Participants	8 Participants
Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) POD7	5 Participants	5 Participants	10 Participants

SECONDARY outcome

Timeframe: 1 day and 7 days after surgery

Population: All patients completed the full survey, however some patients expressed that they felt some questions were not applicable to their post-operative cataract recovery and did not provide a score. We omitted missing data from specific day-of analyses.

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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=9 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall n=19 Participants All study participants who were randomized to receive oral or placebo medication prior to surgery.
Quality of Recovery-15 (QoR-15) Total Score After Surgery POD1	138.7 scores on a scale Standard Deviation 14.9	136.3 scores on a scale Standard Deviation 18.2	137.6 scores on a scale Standard Deviation 16.1
Quality of Recovery-15 (QoR-15) Total Score After Surgery POD7	144.2 scores on a scale Standard Deviation 7.2	142.1 scores on a scale Standard Deviation 11.2	142.9 scores on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: 1 day and 7 days 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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 Participants An oral placebo pill will be administered to patients prior to the procedure.	Overall n=20 Participants All study participants who were randomized to receive oral or placebo medication prior to surgery.
Functional Recovery Index (FRI) Total Score After Surgery POD1	10.1 scores on a scale Standard Deviation 12.3	2.8 scores on a scale Standard Deviation 4.3	6.4 scores on a scale Standard Deviation 9.7
Functional Recovery Index (FRI) Total Score After Surgery POD7	10.8 scores on a scale Standard Deviation 18.6	2.6 scores on a scale Standard Deviation 4.7	6.7 scores on a scale Standard Deviation 13.7

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=10 participants at risk Oral sedation will be administered to patients prior to the procedure.	Placebo n=10 participants at risk An oral placebo pill will be administered to patients prior to the procedure.
General disorders Emergency Room Visit	0.00% 0/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit	10.0% 1/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit
Ear and labyrinth disorders Vertigo	10.0% 1/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit	0.00% 0/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit
Renal and urinary disorders Emergency Room Visit	10.0% 1/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit	0.00% 0/10 • from enrollment until end of chart review, up to 30 days after the post-operative visit

Additional Information

Catherine Chen

University of California, San Francisco

Phone: 415-476-0683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place