Efficacy of a premedication with melatonin during cataract surgery under peribulbar block: a prospective randomized double-blinded study

Pr. Hosni KHOUADJA0 个研究点目标入组 60 人开始时间: 2022年8月16日最近更新: 2023年5月29日

适应症

试验速览

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•oral and written informed consent of the patients
•an age over 50 years old
•an ASA class I, II, III
•a cataract of senile origin
•a cataract complicating an ophthalmological pathology such as uveitis or pigmentary retinopathy
•a cataract complicating an extra-orbital pathology such as diabetes, chronic inflammatory diseases and hypoparathyroidism
•a post-traumatic cataract
•a cataract of iatrogenic origin following long-term corticosteroid therapy or orbital radiation therapy

•a psychiatric history
•a history of long-term use of sedatives, anxiolytics or analgesics
•a history of complications from ophthalmic surgery
•sleep disorders
•cognitive or sensory disorders
•a congenital cataract (embryopathies or hereditary)
•a cataract secondary to genetic diseases such as Trisomy 21 or Steinert’s dystrophy
•a secondary cataract on implant following a posterior capsular opacification
•a strong myopia staphyloma
•a glaucoma in the controlateral eye
•a contraindication of the use of melatonin
•a contraindication to loco-regional anesthesia
•any indications to convert to general anesthesia such as failure of loco-regional anesthesia technique
•failure to comply with the 60-minute premedication period
•a surgical procedure that has exceeded the half-elimination time of melatonin (120 minutes)
•an intra operative anesthetic complications
•an intra operative surgical complications such as an expulsive hemorrhage of the eyeball, rupture of the capsule with vitreous exit, capsular or zonular rupture, or a non compliant implant

发起方

Pr. Hosni KHOUADJA