Cognitive Impairment Clinical Trial
Official title:
Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery
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)
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2025 |
Est. primary completion date | May 2025 |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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
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 |
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