Phase 4
Completed N=105
Sedation Methods During Cataract Surgery
Phacoemulsification · Cataract
Source: ClinicalTrials.gov NCT03054103 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Eye Mobility During Surgery (See Link to Study Protocol for Scale) — 1.39; 1.41; 1.31 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eye Mobility During Surgery (See Link to Study Protocol for Scale) |
1.39; 1.41; 1.31 | — |
| SECONDARY Measure of Comfort (See Link to Study Protocol for Scale) |
1.29; 1.18; 1.17 | — |
| SECONDARY PACU Length of Stay |
19.2; 19.0; 20.1 | — |
| SECONDARY Nausea |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients met inclusion criteria if they were between 18- and 80-years-old and undergoing elective cataract surgery performed by a single ophthalmologist (KW).
Exclusion Criteria
- Patients younger than 18, older than 80, those with a serum creatinine >3 mg/dl, advanced liver disease (liver enzymes twice the normal range or higher), and those with an allergy to any of the study medications were excluded from the study.
Data sourced from ClinicalTrials.gov (NCT03054103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.