Abstract
Abstract Study question What are the patient-reported-outcomes (PROs) and patient-reported-experiences (PREs) of deep sedation performed by sedation practitioners during oocyte retrievals compared to light-sedation by the fertility nurse? Summary answer Women undergoing oocyte retrievals with deep sedation by a sedation practitioner had a better experience and classified sedation the preferred method compared to light-sedation. What is known already Vaginal oocyte retrieval is a key step in modern IVF. The procedure is painfull, requiring systemic analgesics and anxiolytics which is called sedation. Light sedation is still the norm in the Netherlands although women prefer stronger analgesia, less anxiety, and less side effects such as nausea and vomiting from the opiods. From a safety point of view, the ministry of health (IGJ) recommends to perform sedation in an out-patient setting only by sedation professionals. It is known dat deep sedation delivered by trained sedation practitioners in an outpatient clinic is feasible in the Netherlands in other fields (gastroenterology etc). Study design, size, duration Prospective cohort study. In September 2021, moderate-to-deep sedation was introduced for oocytes retrievals for 5 days per week. In weekends, light sedation by the fertility nurse remained the standard. This enabled us to study PROs, defined as the view of participating women of their healthcare status, and PREs, defined as the perception of the received care, in both sedation strategies. PROs were assessed with the validated EuroQol-5D-5L questionnaire and PREs with the Iowa-Satisfaction-with Anesthesia-Scale (ISAS). Participants/materials, setting, methods All women who were scheduled for oocyte retrieval were asked to participate in PRO and PRE assessment. We assessed PROs at three time points: (i) day of trigger, (ii) 6-8 hours after discharge, (iii) 24-32 hours after oocyte retrieval. PREs were assessed 24-32 hours after oocyte retrieval. We intended to include 400 consecutive women. We performed mixed-model-analysis for between-group comparison of treatment and time effects (PROs) and a multivariate regression analysis (PRE). Main results and the role of chance A total of 460 women were scheduled for oocyte retrieval. Moderate-to deep sedation was offered 361 women and 352 (98%) received this. Light sedation was offered 83 women and 76 (92%) received this. Women with less than 3 follicles usually received analgesia only; their data were not used. Concerning the PROs, complete baseline questionnaires were available for 404/440 (93%) of women We found a significant time effect on “anxiety/sadness symptoms” which where high at (i) day of trigger in both groups and lowered at (ii) 6-8 hours after discharge; and a significant time effect in “pain” at (ii) 6-8 hours after discharge. We found no treatment effect of moderate-to-deep sedation versus light sedation for the PROs (p = 0.62). Concerning the PREs, the ISAS was scored for 398/440 (90%) of women. The maximum ISAS score is 3 points. The mean ISAS score was significantly higher in the moderate-to-deep sedation group compared to light sedation, indicating a better experience (1.8 ± 0.7 vs 0.9 ± 0.9, p = <0.001). Moderate-to-deep sedation was rewarded higher compared to light sedation because of less pain during the procedure (4 points better), more satisfaction (1 point better) and preference for same sedation in the future (1,5 points better). Limitations, reasons for caution The results are only applicable to the patient population of a tertiary out patient care setting. Wider implications of the findings Measurement of PREs (ISAS) should be standard-of-care to measure experiences of ambulant sedation. Our interpretation is that gynaecologists should abandon light sedation by non-anaesthesiologists and we suggest to provide deep sedation by the sedation professionals only. Trial registration number not applicable
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