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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202210764449003
Enrollment
60
Registered
2022-10-04
Start date
2022-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases Anaesthesia

Interventions

Sponsors

Pr. Hosni KHOUADJA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
a 50 percent reduction in the average total dose of intraoperative midazolam and alfentanyl consumption with melatonin premedication

Secondary

MeasureTime frame
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

Countries

Tunisia

Contacts

Public ContactFadoua MIGHRI

Anesthesia and intensive care department

fadouamighri@gmail.com+21695635175

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026