Cataract Clinical Trial
Official title:
A Comparison of Midazolam vs. Midazolam/Ketamine for Conscious Sedation in Patients Undergoing Phacoemulsification Under Topical Anesthesia
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 105 |
Est. completion date | November 11, 2016 |
Est. primary completion date | November 5, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Wake Forest University Health Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eye Mobility During Surgery (See Link to Study Protocol for Scale) | Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery). | Intraoperative, end of operation reported | |
Secondary | Measure of Comfort (See Link to Study Protocol for Scale) | Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable | Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic. | |
Secondary | PACU Length of Stay | This is obtained from the records as time spent in the PACU (Recovery Room) after surgery. | This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed. | |
Secondary | Nausea | 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 | This will occur from time of entry into PACU to time of departure after their surgery. (One time only, in a range of 20 to 30 minutes after surgery. |
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