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

Not Applicable

• Conditions: Eye Diseases; Anaesthesia

• Registration Number: PACTR202210764449003
• Lead Sponsor: Pr. Hosni KHOUADJA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a 50 percent reduction in the average total dose of intraoperative midazolam and alfentanyl consumption with melatonin premedication

Secondary Outcome Measures

Name	Time	Method
intra operative sedation ;intraoperative analgesia;Perioperative anxiety;Intraocular pressure;Patients satisfaction;Surgeons satisfaction;total dose of bolus of nicardipine ;recovery of psychomotor function;advese effects of melatonin;heart rate;respiratory rate;Pulsed O2 saturation;Systolic arterial blood pressure;Diastolic arterial blood pressure;Mean arterial blood pressure;Occurence of an oculo-cardiac reflex