백내장 모니터링 마취 관리(MAC) 타당성 파일럿 연구 (CaTNAPS-1)

실험적: 간섭

시술 전 환자에게 경구 진정제가 투여됩니다.

절차: 경구 진정제

수술 전 환경에서 투여되는 불안 완화용 경구 약물

위약 비교기: 위약

시술 전에 경구 위약 알약이 환자에게 투여됩니다.

절차: 위약

수술 전 환경에서 활성 성분이 포함되지 않은 위약 알약을 투여합니다.

Number of Participants With High Satisfaction (ISAS Score ≥ 2)

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.

Number of Participants Meeting Eligibility Criteria at Screening

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

Number of Participants Completing All Study Surveys at Each Timepoint

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

Number of Participants Who Completed All Required Study Procedures

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)

Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up

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

Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)

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.

Quality of Recovery-15 (QoR-15) Total Score After Surgery

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.

Functional Recovery Index (FRI) Total Score 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.