Cataract Clinical Trial
Official title:
A Comparison of Midazolam vs. Midazolam/Ketamine for Conscious Sedation in Patients Undergoing Phacoemulsification Under Topical Anesthesia
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.
Phacoemulsification is the most common surgical procedure performed in the United States and
European Union. In addition, the number of diagnoses of cataracts is expected to double from
25,000,000 in 2010 to 50,000,000 in 2050 while the incidence of phacoemulsification is also
increasing. Therefore, any attempt to optimize outcome and efficiency is significant.
Sedation is commonly used during phacoemulsification to help alleviate patient anxiety and
prevent the patient from interfering with the procedure. However, a great deal of variation
exists in anesthetic management of these cases. Investigators have published use of a number
of agents for sedation in the literature. These include midazolam, clonidine, propofol,
fentanyl, dexmedetomidine, remifentanil, and oral diazepam. Intravenous (IV) clonidine has a
half-life of 9-13 h and increased risk of postoperative hypotension. Propofol causes
disinhibition and it has to be titrated during surgery to prevent oversedation. Opioids carry
an increased risk of respiratory depression, prolonged sedation, as well as delirium in the
elderly. Finally, oral medications do not allow for quick dose adjustments during surgery.
Intravenous midazolam is commonly used for sedation during phacoemulsification and other
minor procedures. It has properties as an anxiolytic, muscle relaxant, and it is effective at
reducing intraocular pressure. However, anxious patients administered benzodiazepines may
require higher doses during cataract surgery which can lead to oversedation or disinhibition
with subsequent patient movement. These responses can reduce the patient's ability to follow
simple commands which can affect surgical outcome. Additionally, patients who receive too
much sedation may fall asleep and wake up startled, similarly compromising the outcome of the
surgery.
In the search for additional medications that can improve surgical conditions and patient
comfort during phacoemulsification, the investigators explored the use of a medication that
can improve analgesia and reduce patient movement during procedures, namely ketamine.
Ketamine is an NMDA antagonist with both sedative and analgesic properties and has minimal
effects on respiration. Ketamine has been used to premedicate and sedate patients undergoing
day care procedures without adverse effects, and patients, typically, remain cooperative
albeit being sedated. These properties along with its relatively short elimination half-life
of 2 h (compared with 3-4 h for midazolam) make ketamine an attractive agent for sedation
during monitored anesthesia care (MAC) for cataract surgery.
The purpose of this study was 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 IV conscious sedation.
The investigators measured the surgeon's assessment of the participant's cooperation during
surgery according to a predetermined Likert scale. The investigators also recorded the
following outcome measures regarding each participant's surgery: 1) total dose of midazolam,
2) average time spent in the procedural room, 3) postoperative length of stay (LOS), and 4)
average postoperative pain score. The subjects received a survey inquiring about the
subjects' comfort and sedation level during surgery. Finally, the investigators recorded the
following demographic data for all participants: gender, age, psychiatric diagnoses, and use
of CNS, psychiatric, or opioid medications.
Statistical Analysis The investigators used Fisher's exact test for examining data expressed
as percentages, and Students t-test for yes/no data, and repeated measures ANOVA for 3 group
analysis (LOS, surgical duration). The investigators judged significance at a P-value of
0.05. The investigators utilized a generalized estimated equations (GEE) to fit a logistic
model to assess differences in the responses of patients based on amount of ketamine
received. The GEE approach can fit models to correlated outcomes, as in the case where
subjects had more than one procedure performed.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04685538 -
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
|
Phase 3 | |
Recruiting |
NCT06060041 -
IC-8 Apthera IOL New Enrollment Post Approval Study
|
||
Recruiting |
NCT05518539 -
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
|
||
Recruiting |
NCT05271942 -
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
|
N/A | |
Active, not recruiting |
NCT04778501 -
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
|
N/A | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT03751033 -
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
|
N/A | |
Completed |
NCT02529488 -
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
|
N/A | |
Completed |
NCT04539548 -
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
|
Phase 3 | |
Completed |
NCT03740659 -
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
|
Phase 2 | |
Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
Completed |
NCT05119127 -
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
|
N/A | |
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT03739528 -
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
|
Phase 3 | |
Completed |
NCT02888210 -
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
|
Phase 3 | |
Completed |
NCT03356847 -
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
|
N/A | |
Completed |
NCT04332640 -
Clinical Evaluation of the Next Generation Phaco System
|
N/A | |
Recruiting |
NCT03638726 -
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
|
Phase 4 | |
Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A |