Remimazolam for Cataract Surgery

Официальное название

Comparison of Remimazolam vs. Midazolam for Sedation During Cataract Surgery

Обзор

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)

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in MoCA score following surgery in the PACU and post operative day 1. [Срок оценки: Immediately following surgery in the PACU and post operative day 1.]
• Change in MoCA Scores in PACU and the next day between midazolam and remimazolam group. [Срок оценки: Immediately following surgery in the PACU, and post operative day 1.]
• Length of postoperative stay [Срок оценки: Postop day 0 (day of surgery) until discharge from the hospital, usually on postop day 1 (an average of 1 day).]

Вторичные конечные точки (2)

• Surgeon Satisfaction [Срок оценки: Intraoperatively to postoperatively in the ICU, and expected average of 1 hour.]
• Patient Satisfaction [Срок оценки: Day of surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Публикации

• 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. PMID 30059403
• 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. PMID 2719292
• 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. PMID 21502855
• 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. PMID 15817019
• 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. PMID 2286697
• 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. PMID 34907594

Идентификаторы

NCT: NCT05980117 · 22-001570

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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