PACTR202210764449003Not yet recruiting未知
Efficacy of a premedication with melatonin during cataract surgery under peribulbar block: a prospective randomized double-blinded study
Pr. Hosni KHOUADJA0 sites60 target enrollmentStarted: August 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 45 Year(s) to 64 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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