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临床试验/NCT06793150
NCT06793150已完成4 期

Comparison of the Effects of Opioid-Based Anesthesia Versus Opioid-Free Anesthesia on Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries

Kocaeli University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年9月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
cognitive dysfunction

研究概览

简要总结

In this study, the patients undergoing pituitary surgery in our clinic have examined in two groups. In the first group, anesthesia maintenance was provided with remifentanil and propofol infusion. In the second group, anesthesia maintenance was provided with dexmedetomidine and propofol infusion. Demographic data, vital signs during the operation, wake-up time, extubation time, and drug consumption amounts were recorded. The mini-mental test was applied preoperatively, 24 hours postoperatively, and 3 weeks postoperatively to examine whether there is a difference in cognitive dysfunction between the two groups.

详细描述

Postoperative cognitive dysfunction refers to disorders affecting orientation, attention, perception, consciousness, and judgment that develop after surgery. It is a common postoperative complication and a serious threat to the quality of life, particularly for elderly patients. Strategies to prevent surgery and anesthesia-induced cognitive dysfunction are being investigated, considering the choice and depth of anesthesia, perioperative anesthetic and other drugs, and surgical strategy.

Opioid-free anesthesia involves the administration of intraoperative anesthesia without the use of intraoperative opioids. Currently available non-opioid drugs include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) (ketorolac, ibuprofen, celecoxib), alpha-2 agonists (dexmedetomidine, clonidine, tizanidine), and N-methyl-D-aspartate (NMDA) receptor antagonists (ketamine). Dexmedetomidine (DEX) is an alpha-2 adrenoceptor agonist with a selectivity ratio of 1600:1 (α2:α1). It promotes sedation by acting on the α2 receptors of the locus coeruleus and produces analgesia by reducing the release of substance P in the spinal cord dorsal horn.

The goals of opioid use during anesthesia are to reduce the need for hypnotic agents and provide effective analgesia. However, the potential side effects of opioids can be described as having a threefold negative impact, ranging from sudden adverse reactions in the patient to the long-term sequelae of chronic effects.

In this study, the patients undergoing pituitary surgery in our clinic have examined in two groups. In the first group, anesthesia maintenance was provided with remifentanil and propofol infusion. In the second group, anesthesia maintenance was provided with dexmedetomidine and propofol infusion. Demographic data, vital signs during the operation, wake-up time, extubation time, and drug consumption amounts were recorded. The mini-mental test was applied preoperatively, 24 hours postoperatively, and 3 weeks postoperatively to examine whether there is a difference in cognitive dysfunction between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

group d maintaiance with dexmedetomidine group r maintainence with remifentanile

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing transsphenoidal pituitary elective surgery
  • Patients classified as ASA (American Society of Anesthesiologists) physical status classification I-III
  • Patients aged between 18 and 65 years

排除标准

  • Patients scheduled for emergency surgery
  • Patients classified as ASA (American Society of Anesthesiologists) physical status classification IV-V
  • Patients with psychiatric disorders
  • Patients with a history of stroke, dementia, electrolyte disturbances, or serious liver and/or kidney disease
  • Patients with a history of substance abuse"

研究组 & 干预措施

group d

Active Comparator

group d anesthesia maintaiance with dexmedetomidine

干预措施: dexmedetomidin (Drug)

group r

Active Comparator

group r anesthesia maintainence with remifentanile

干预措施: Remifentanil (Drug)

结局指标

主要结局

cognitive dysfunction

时间窗: preoperative, postoperative 24th hour and 3rd week

Our primary objective is comparing postoperative cognitive dysfunction using the Mini-Mental State Examination after anesthesia 24 hours and 3 weeks after surgery

次要结局

  • comparing anesthesia and opioid free anesthesia(preoperative, postoperative 24th hour and 3rd week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökçe Çile Özer

principal investigator

Kocaeli University

研究点 (1)

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