[Study protocol of the monocentric prospective randomized placebo-controlled double-blind phase II study to explore the protective effects of the ginkgo biloba extract EGb 761® from temporary noise-induced hearing loss]. / Prüfplan für die monozentrische prospektive randomisierte placebokontrollierte doppelblinde Phase-II-Studie zur Exploration protektiver Effekte des Ginkgo-biloba-Spezialextrakts EGb 761® vor einer vorübergehenden Hörschädigung durch Lärm.

BACKGROUND: Hearing loss is frequently induced by occupational noise exposure and leads to rising hearing thresholds as well as reduced otoacoustic emissions (OAE), mostly caused by metabolic hair cell decompensation. OBJECTIVE: Primary endpoint is the increase in average pure tone thresholds after noise exposure, secondary endpoints are loss of distortion product and click-evoked OAE as well as reduction of their contralateral suppression. PARTICIPANTS AND METHODS: The present study design describes the verification of the anti-oxidant and neuroprotective properties of EGb 761® by evaluation of cochlear protection from noise impact as well as its safety and tolerance in 202 healthy male participants distributed equally to verum and placebo groups in a double-blind manner. Participants were assessed, medicated, exposed to noise, and then examined at timepoints up to 10 min and 4 weeks thereafter. CONCLUSION: This summary of the verification study protocol highlights the complexity of diligent and precise planning according to the European Medicines Agency criteria for controlled trials (EudraCT). Key points are the intervention rationale, definitions of in- and exclusion criteria, estimation of subject numbers, and examination method setting in terms of optimum endpoint description.

[Perioperative anxiety and postoperative pain suppression in intraocular operations using general anesthesia and local anesthesia]. / Perioperatives Angsterleben und postoperatives Schmerzverhalten bei intraokulären Eingriffen in Allgemeinanaesthesie und Lokalanaesthesie.

UNLABELLED: Intraocular surgery is performed under local or general anesthesia. The indications for these procedures are often dependent on local circumstances. On the one hand, the optimal conditions for operations under general anesthesia, on the other, the negligible stress of local anesthesia, especially for the elderly, are emphasized. To clarify this question, perioperative anxiety behavior and postoperative pain were investigated in geriatric patients undergoing ophthalmic surgery. METHODS: Spielberger's state trait anxiety inventory (STAI) was performed in 31 patients operated on in general (age 71.0 +/- 6.6 SEM) and 31 operated on in local anesthesia (age 71.6 +/- 6.0 SEM) the day before and 4 h after operation. 10 patients in each group were also tested immediately before surgery in the operating room. Postoperative pain was estimated by the patient and postoperative sedation by the investigator using a 4-point scale for each over 8 h. RESULTS: The state (STAI 1) and trait (STAI 2) anxiety scores did not change in these geriatric patients. There were no significant differences between the groups. Postoperative pain was significantly (p less than 0.05) higher after 15 and 60 min after general anesthesia. There was no difference in the frequency of analgetic therapy in both groups, but most opioids were given in the first 90 min after general anesthesia. The patients were more frequently sedated (p less than 0.05) in the first 90 min after general anesthesia then after local anesthesia. DISCUSSION: The scores of state and trait anxiety behavior are comparable to a normal geriatric population, even if normal data cannot always be applied to clinical situations.(ABSTRACT TRUNCATED AT 250 WORDS)