Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Emergence Time
研究概览
简要总结
The purpose of this study is to assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
详细描述
Based on this significant arousal stimulatory effect, the investigators hypothesize that methylphenidate (inhibitor of dopamine and norepinephrine transporters) decreases the emergence time from isoflurane general anesthesia.
PRIMARY OBJECTIVE:
To assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
SECONDARY OBJECTIVES:
- To assess the efficacy of methylphenidate in preventing post operative nausea and vomiting (PONV) by limited opioids consumption: PONV verbal response scale on a 0 to 10 verbally elicited scale: 0 (no nausea) to 10 (nausea as bad as it could be)
- To assess the efficacy of methylphenidate in preventing opioids dose escalation (fast cognitive improvement with efficient pain control -Postoperative Pain Numeric Rating Scale: O=None; (1-3)=Mild; (4-6)= Moderate; (7-10)=Severe).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or female, 18 to 65 years of age
- •ASA I or II
- •Capable and willing to consent
- •Participants literate in English language
排除标准
- •ADHD with current use of methylphenidate
- •Hypersensitivity to methylphenidate
- •ASA III, IV or V
- •Patients with severe visual or auditory disorder
- •Illiteracy
- •Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
- •Tics or Tourette's syndrome
- •Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter), myocardial infarction
- •Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI (Selegiline)
- •Subjects who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery
- •Any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable Diabetes type I/II)
研究组 & 干预措施
Methylphenidate
Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery
干预措施: Methylphenidate HCl (Drug)
Placebo
20 mg Placebo (PO) given 2 hours prior to surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Emergence Time
时间窗: From the moment when isoflurane infusion is stopped until time of extubation
After stopping isoflurane infusion, when the patient breathes spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.
次要结局
- Number of Participants That Experienced Postoperative Nausea and Vomiting(First 24 Hours Postoperatively)
- Opioid Dose Escalation Prevention(During the length of hospital stay post surgery (on average 24 hours), and up to 3 days after surgery)
研究者
Nicoleta Stoicea
Research Scientist, Adj. Assistant professor
Ohio State University