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Sedation Methods During Cataract Surgery
Phase 4 trial testing Midazolam + Ketamine 10 MG/ML: 0.5 ML in Phacoemulsification in 105 participants. Completed in 11 November 2016.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 3 May 2016 |
| Primary completion | 5 November 2016 |
| Estimated completion | 11 November 2016 |
Wake Forest University Health Sciences
Adults 18 to 80, any sex, with Phacoemulsification or Cataract. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).
| Group | Value | 95% CI |
|---|---|---|
| Midazolam Alone | 1.39 | ± 0.63 |
| Midazolam + Ketamine 5 mg | 1.41 | ± 0.63 |
| Midazolam + Ketamine 10 mg | 1.31 | ± 0.63 |
Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable
| Group | Value | 95% CI |
|---|---|---|
| Midazolam Alone | 1.29 | ± 0.62 |
| Midazolam + Ketamine 5 mg | 1.18 | ± 0.60 |
| Midazolam + Ketamine 10 mg | 1.17 | ± 0.59 |
This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.
| Group | Value | 95% CI |
|---|---|---|
| Midazolam Alone | 19.2 | ± 7.7 |
| Midazolam + Ketamine 5 mg | 19.0 | ± 6.5 |
| Midazolam + Ketamine 10 mg | 20.1 | ± 10.7 |
Self-reported incidence of nausea. This will be assessed by asking the subjects once (just prior to discharge from the PACU) whether they experienced any nausea while they were in the PACU (Recovery Room) and will be a measurement of the count of participants that experienced nausea during this period
| Group | Value | 95% CI |
|---|---|---|
| Midazolam Alone | 0 | |
| Midazolam + Ketamine 5 mg | 0 | |
| Midazolam + Ketamine 10 mg | 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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