Remimazolam for Cataract Surgery

Cognitive Impairment Clinical Trial

Official title:

Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980117
• Other study ID #: 22-001570
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2024
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Zhuang T Fang, MD
• Phone: 310-267-8946
• Email: ZFang[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 1. Complete MoCA testing prior to surgery 2. Randomize in either Midazolam or study drug Remimazolam 3. 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. 4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients age > 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).

2. Both male and female patients

3. American Society of Anesthesiologists Class 2, 3, and 4.

Exclusion Criteria:

1. Patients who are unable to consent for the study

2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.

3. Patients who are unable to understand simple English commands.

4. Patients who do not wish to have benzodiazepine medication during surgery

5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.

6. Patients with chronic pain on opiates.

7. Patients with a history of drug, alcohol abuse/dependence.

8. Patients with BMI > 40.

9. Patients with obstructive sleep apnea (moderate to severe).

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Cognitive Impairment

Intervention

Drug:
• Remimazolam
Remimazolam (1.0mg IV) titrated to modified observer's assessment of sedation score of 3 -4 during cataract surgery.
• Midazolam
Midazolam (0.5-2mg IV) titrated to modified observer's assessment of sedation score of 3 - 4 during cataract surgery.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately following surgery in the PACU and post operative day 1.
Primary	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.	Immediately following surgery in the PACU, and post operative day 1.
Primary	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:	Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).
Secondary	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.	Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.
Secondary	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.	Day of surgery