drugset / Trial / NCT03933280

Conscious Sedation for Cataract Operations Under Topical Anaesthesia

NCT03933280

Phase 2 Completed 100 enrolled Menoufia University
RandomizedParallel-groupDouble-blindOther

Summary

Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes

Timeline

Start
2019-07-01
Primary completion
2020-12-01
Completion
2021-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Comparator Propofol Small molecule 0.025 mg/kg Intravenous
Comparator Benoxinate Small molecule 0.4 % Topical
Comparator Nalbuphine Small molecule 50 ug/kg Intravenous

Indications

No indication recorded.