Sedation Methods During Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT03054103|
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : January 19, 2018
Last Update Posted : September 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Phacoemulsification Cataract||Drug: Midazolam + Ketamine 10 MG/ML: 0.5 ML Drug: Midazolam + Ketamine 10 MG/ML: 1 ML Drug: Midazolam + Normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, controlled, double-masked, three-armed clinical comparison|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Surgical conditions and patient response not aware of medication given.|
|Official Title:||A Comparison of Midazolam vs. Midazolam/Ketamine for Conscious Sedation in Patients Undergoing Phacoemulsification Under Topical Anesthesia|
|Actual Study Start Date :||May 3, 2016|
|Actual Primary Completion Date :||November 5, 2016|
|Actual Study Completion Date :||November 11, 2016|
Placebo Comparator: Midazolam alone
Drug: Midazolam titrated 0.5-2.0 mg + normal saline placebo. Midazolam + Normal saline
Drug: Midazolam + Normal saline
Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.
Other Name: NS
Active Comparator: Midazolam + Ketamine 5 mg
Drug: Midazolam titrated 0.5-2.0 mg + Ketamine 10 MG/ML: 0.5 ML. Midazolam + Ketamine 10 MG/ML: 0.5 ML
Drug: Midazolam + Ketamine 10 MG/ML: 0.5 ML
5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Other Name: Ketalar
Active Comparator: Midazolam + Ketamine 10 mg
Drug: Midazolam titrated 0.5-2.0 mg + Ketamine 10 MG/ML: 1 ML. Midazolam + Ketamine 10 MG/ML: 1 ML
Drug: Midazolam + Ketamine 10 MG/ML: 1 ML
10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Other Name: Ketalar
- Eye Mobility During Surgery (See Link to Study Protocol for Scale) [ Time Frame: Intraoperative, end of operation reported ]Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).
- Measure of Comfort (See Link to Study Protocol for Scale) [ Time Frame: Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic. ]Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable
- PACU Length of Stay [ Time Frame: This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed. ]This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.
- Nausea [ Time Frame: 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. ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054103
|Principal Investigator:||Timothy N Harwood, MD||Wake Forest University Health Sciences|