drugset / Trial / NCT03054103

Sedation Methods During Cataract Surgery

NCT03054103 ↗

Phase 4 Completed 105 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupTriple-blindTreatment

Summary

Background: Phacoemulsification is the most common surgical procedure performed in the United States and European Union and sedation is commonly used during phacoemulsification to help alleviate patient anxiety and prevent the patient from interfering with the procedure. The investigators have administered ketamine in addition to midazolam in this regard. To study the effectiveness of this technique, The investigators proposed a study to determine if adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating conditions, patient satisfaction, and recovery during and after unilateral phacoemulsification procedures performed using topical anesthesia and intravenous (IV) conscious sedation. Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured a single surgeon's assessment of surgical conditions, self-reported patient satisfaction, postoperative pain score, and duration of postoperative stay. The investigators also analyzed the dose of midazolam required to meet subjective anxiolysis in each group.

Timeline

Start
2016-05-03
Primary completion
2016-11-05
Completion
2016-11-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 5 mg Intravenous
Comparator Ketamine Small molecule 10 mg Intravenous
Comparator Midazolam Small molecule 2 mg Intravenous

Indications