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Remimazolam for Cataract Surgery

Primary Purpose

Cataract Surgery, Cognitive Impairment

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Remimazolam
Midazolam
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery focused on measuring Midazolam, Remimazolam, Outcomes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA). Both male and female patients American Society of Anesthesiologists Class 2, 3, and 4. Exclusion Criteria: Patients who are unable to consent for the study Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment. Patients who are unable to understand simple English commands. Patients who do not wish to have benzodiazepine medication during surgery Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Patients with chronic pain on opiates. Patients with a history of drug, alcohol abuse/dependence. Patients with BMI > 40. Patients with obstructive sleep apnea (moderate to severe).

Sites / Locations

  • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Patients assigned to the study group will receive Remimazolam.

Patients assigned to the control group will receive Midazolam.

Outcomes

Primary Outcome Measures

Change in MoCA score following surgery in the PACU and post operative day 1.
Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment
Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Length of postoperative stay
Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:

Secondary Outcome Measures

Surgeon Satisfaction
Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.
Patient Satisfaction
Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.

Full Information

First Posted
June 21, 2023
Last Updated
September 14, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05980117
Brief Title
Remimazolam for Cataract Surgery
Official Title
Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery. Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA). Participants will: Complete MoCA testing prior to surgery Randomize in either Midazolam or study drug Remimazolam Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)
Detailed Description
Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is the most common eye surgery performed in elderly patients. Although cataract surgery is a minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is administered during surgery to allay a patient's anxiety. The purpose of this study is to look at any difference in postoperative cognitive changes as well as recovery times in the PACU following administration of midazolam or remimazolam. Patients will be asked to participate in a clinical trial where they will be randomly assigned to midazolam or remimazolam group. Cognitive changes will be assessed by administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes) screening tool for detection of mild neurocognitive dysfunction. Given the short half life of remimazolam, investigators hypothesize that any cognitive changes will be less with remimazolam compared to midazolam. Patients will be asked to complete MoCA prior to surgery, in the recovery room following surgery, and the next day during their post-operative clinic visit. In addition, patients will be asked to rate their satisfaction of their anesthetic during their surgery. The participant will be in this research study from the day of surgery until the first post-operative visit, the following day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery, Cognitive Impairment
Keywords
Midazolam, Remimazolam, Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to the intervention group receiving Remimazolam or to the control group receiving Midazolam.
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients assigned to the study group will receive Remimazolam.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients assigned to the control group will receive Midazolam.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Other Intervention Name(s)
Byfavo
Intervention Description
Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.
Primary Outcome Measure Information:
Title
Change in MoCA score following surgery in the PACU and post operative day 1.
Description
Montreal Cognitive Assessment (MoCA) test. A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment
Time Frame
Immediately following surgery in the PACU and post operative day 1.
Title
Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group.
Description
Montreal Cognitive Assessment (MoCA) test. The following ranges may be used to grade severity: A numerical scale is used for scoring. 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Time Frame
Immediately following surgery in the PACU, and post operative day 1.
Title
Length of postoperative stay
Description
Duration from the time of admission to readiness for discharge from the PACU. The following ranges may be used to grade severity:
Time Frame
Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).
Secondary Outcome Measure Information:
Title
Surgeon Satisfaction
Description
Surgeon satisfaction score will be assessed post-surgery as measured by a 5-point scale with 1 = Strongly Disagree , 2 = Disagree , 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree.
Time Frame
Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.
Title
Patient Satisfaction
Description
Patient satisfaction score will be assessed at the time of discharge by a 5 point scale with 1 = Disagree Strongly , 2 = Disagree Somewhat , 3 = Neither Agree or Disagree, 4 = Agree Somewhat, 5 = Agree Strongly.
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA). Both male and female patients American Society of Anesthesiologists Class 2, 3, and 4. Exclusion Criteria: Patients who are unable to consent for the study Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment. Patients who are unable to understand simple English commands. Patients who do not wish to have benzodiazepine medication during surgery Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Patients with chronic pain on opiates. Patients with a history of drug, alcohol abuse/dependence. Patients with BMI > 40. Patients with obstructive sleep apnea (moderate to severe).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuang T Fang, MD
Phone
310-267-8946
Email
ZFang@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie-Dee Sarovich, BS
Phone
424-832-6842
Email
ssarovich@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuang Fang, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie-Dee Sarovich, B.S.
Phone
424-832-6842
Email
ssarovich@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Gundappa Neelakanta, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30059403
Citation
Rabinowitz LE, Lamper L, Tendler JM, Schlesinger JM, Vera N. Preventing Adverse Events in Cataract Surgery. Anesth Analg. 2018 Oct;127(4):e66. doi: 10.1213/ANE.0000000000003655. No abstract available.
Results Reference
background
PubMed Identifier
2719292
Citation
Chung F, Lavelle PA, McDonald S, Chung A, McDonald NJ. Cognitive impairment after neuroleptanalgesia in cataract surgery. Anesth Analg. 1989 May;68(5):614-8.
Results Reference
background
PubMed Identifier
21502855
Citation
Evered LA, Silbert BS, Scott DA, Maruff P, Ames D, Choong PF. Preexisting cognitive impairment and mild cognitive impairment in subjects presenting for total hip joint replacement. Anesthesiology. 2011 Jun;114(6):1297-304. doi: 10.1097/ALN.0b013e31821b1aab.
Results Reference
background
PubMed Identifier
15817019
Citation
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
2286697
Citation
Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
Results Reference
background
PubMed Identifier
34907594
Citation
Tan Y, Ouyang W, Tang Y, Fang N, Fang C, Quan C. Effect of remimazolam tosilate on early cognitive function in elderly patients undergoing upper gastrointestinal endoscopy. J Gastroenterol Hepatol. 2022 Mar;37(3):576-583. doi: 10.1111/jgh.15761. Epub 2022 Jan 3.
Results Reference
background

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Remimazolam for Cataract Surgery

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