Beyond Inhalational Agents: Dexmedetomidine for Maintenance of General Anesthesia - A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Depth of anesthesia
研究概览
简要总结
The climate crisis and environmental pollution are escalating day by day, making the reduction of carbon footprints increasingly important both on an individual and industrial level. Inhalational anesthetic agents are widely used in daily anesthesia practice. However, some of these agents are released into the environment either unchanged or as metabolic by-products. It can take hundreds of years for these substances to be fully eliminated from nature. Therefore, there is a growing interest in identifying alternative anesthetic agents that are fully metabolized, do not produce waste, have a shorter duration of action, and pose less harm to ecosystems.
Recent clinical studies have shown that dexmedetomidine, when administered intraoperatively via infusion without a loading dose and in combination with inhalational agents, provides more stable hemodynamics and results in a shorter postoperative recovery period. Commonly used as a long-term sedative agent in intensive care units, dexmedetomidine has gained popularity in the intraoperative setting due to its stable hemodynamic profile, low incidence of withdrawal symptoms, and faster recovery.
In this study, it is aimed to demonstrate the potential use of dexmedetomidine-whose pharmacodynamic and pharmacokinetic properties are well-known to experienced anesthesiologists-as an alternative to inhalational anesthetic agents for the maintenance of anesthesia, particularly in the geriatric patient population.
详细描述
Study Design and Setting This prospective, randomized clinical study was conducted at the Department of Anesthesiology and Reanimation, University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patient randomization was performed using a computer-based randomization tool (@randomizer).
Patient Selection A total of 150 patients over the age of 39 who provided informed consent and were scheduled for elective urological procedures at the Urology Department were enrolled in the study. The included surgeries were uretero-renoscopic lithotripsy (URS), transurethral resection of the bladder (TUR-B), percutaneous nephrolithotomy (PCNL), and transurethral resection of the prostate (TUR-P).
Anesthesia Protocol
Upon arrival to the operating room, standard monitoring was applied to all patients. Anesthesia induction and maintenance were carried out according to randomization:
Group DR: Dexmedetomidine + Remifentanil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 39 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 39 years
- •Classified as ASA physical status II-IV
- •Scheduled for elective endoscopic urological surgery (e.g., URS, TUR-B, PCNL, TUR-P)
- •Scheduled for postoperative follow-up in the Post-Anesthesia Care Unit (PACU)
- •Ability to provide written informed consent
排除标准
- •Requirement for conversion to open surgery during the perioperative period
- •Patients who decline to participate in the study
- •Presence of neuropsychiatric disorders (e.g., dementia, Parkinson's disease, epilepsy, or history of head trauma)
- •History of alcohol or substance abuse
- •Use of psychoactive medications
- •Inability to communicate adequately for any reason
研究组 & 干预措施
Group DR: Dexmedetomidine + Remifentanil
The investigators will administer dexmedetomidine combined with remifentanil for anesthesia maintenance in this patient group.
干预措施: Dexmedetomidine + Remifentanil (Drug)
Group IR: Desflurane + Remifentanil
The investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group.
干预措施: Desflurane + Remifentanil (Drug)
结局指标
主要结局
Depth of anesthesia
时间窗: Intraoperative period
Depth of anesthesia assessed using Bispectral Index (BIS) monitoring, with BIS values recorded during surgery. The target BIS range will be 40-60.
次要结局
- Intraoperative hemodynamic stability(Intraoperative period)
- Quality of recovery(Postoperative day 1)
- Sedation Level(Post-anesthesia care unit (PACU))
研究者
Nalan Saygi Emir
Specialist Physician
Bakirkoy Dr. Sadi Konuk Research and Training Hospital