Randomized, Parallelled and Double-blinded Trial of Small-dose Dexmedetomidine Effects on Recovery Profiles of Supratentorial Tumors Patients From General Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hemodynamic impacts
研究概览
简要总结
An excellent recovery profile is critical for neurosurgical anesthesia. Rapid awakening, smooth blood pressure and heart rate (HR), a higher degree of coordination, painless or mild pain, as well as better tolerance to endotracheal intubation can avoid can increased intracranial pressure, elevated blood pressure and rapid HR caused by emergency choking, suffocation and agitation, and can reduce postoperative cerebral edema and the risk of bleeding. In addition, it is easy for surgeons to timely evaluate postoperative patients' neurologic function based on the excellent recovery from anesthesia. Up to now, there are many methods and drugs to improve the quality of recovery period, but each of them has some flaws. Dexmedetomidine, an emerging anesthetic adjuvant, exhibits a stable hemodynamic recovery period, and cannot affect evaluation of neurological function with both the sedative and analgesic effects. We propose the following hypotheses: (1) A small dose of dexmedetomidine can be intravenously injected into patients subjected to craniotomy under general anesthesia, in order to improve the recovery profiles and reduce the incidence of emergence agitation. (2) Dexmedetomidine can reduce postoperative pain.
详细描述
Study Arm(s):
Enrollment There are totally 150 cases, 50 cases in each group. At least 120 cases complete the test.
Randomized grouping Under the guidance of a drug administrator, the different drug and control groups are randomly encoded. Each code has a corresponding emergency envelope. Blind codes are saved by the drug administrator.
Interventions :
Experimental Drugs Dexmedetomidine (SFDA Approval No. H20090248), 200 ug/2 ml, provided by the Central Pharmacy of the First Affiliated Hospital of China Medical University and produced by Jiangsu Hengrui Medicine Co., Ltd., China.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologist class (ASA) I & II (ASA I: normal healthy patient; ASA II: patient with mild systemic disease; no functional limitation)；Preoperative MRI diagnosis of supratentorial lesions (glioma, meningioma or neurofibroma), and tumor diameter <= 40 mm；The subject gets full score for Glasgow Coma Score；Estimated operation time <= 6 hours and anesthesia time <= 8 hours；The subject has given written informed consent.
排除标准
- •The subject has participated in other clinical trials at 4 weeks before the beginning of the present study；The subject is taking or has taken β-blockers (such as metoprolol) within 2 weeks before the beginning of the present study；The subject has undergone craniotomy twice or more；The subject has a history of sinus bradycardia (preoperative electrocardiogram of HR <= 50 beats/min), sick sinus syndrome, myocardial infarction, Ⅱ grade and grade Ⅱ cardiac function, and severe hypertension (systolic blood pressure (SBP)> = 180 mmHg or diastolic blood pressure (DBP)> = 110 mmHg)；The subject has a history of lung disease (blood oxygen content <95% when breathing air at an awake state)；The subject has a history of liver dysfunction (1.5 times or more that of the normal value)；The subject has a history of kidney dysfunction (levels of serum creatinine and blood urea nitrogen are out of the normal range)；Hypersensitivity to dexmedetomidine；Tolerance to dexmedetomidine；The subject has a history of drugs or alcohol abuse；The weight exceeds ±15% of standard weight range, and the standard weight is calculated as the following formula: standard weight=body height (cm)-100；Pregnant or lactating women；The subject is considered unsuitable for this trial.
研究组 & 干预措施
low-dose group
S group : dexmedetomidine is infused intravenously at a dose of 0.4 ug/kg
干预措施: dexmedetomidine (Drug)
middle-dose group
M group: dexmedetomidine is infused intravenously at a dose of 0.8 ug/kg
干预措施: dexmedetomidine (Drug)
control group
P group: normal saline is infused intravenously
干预措施: normal saline (Drug)
结局指标
主要结局
Hemodynamic impacts
时间窗: Up to 240 minutes after returning to the ward
Patients' SBP, DBP, MAP and HR are recorded before and every 5 minutes after drug intervention until recovery from anesthesia and removal of the tracheal intubation. Record SBP, DBP, MAP, HR, and SpO2 values immediately after extubation. Record SBP, DBP, MAP, HR, and SpO2 values every 5 minutes after extubation. Record SBP, DBP, MAP, HR, and SpO2 values every 5 minutes after PACU entry. Record SBP, DBP, MAP, HR, and SpO2 values at 0, 60, 120 and 240 minutes after returning to the ward.
次要结局
- Degree of sedation(At tracheal extubation, every 5 minutes after extubation, and at 0, 30, 60, 120, 240 minutes after returning to the ward)
- Sedative effectiveness(Up to 240 minutes after returning to the ward)
- Time of recovery from anesthesia(From the anesthetic induction to extubation)
- Cough assessment at tracheal extubation(At tracheal extubation)
- Test patient's blood pressure during maintenance of anesthesia(During maintenance of anesthesia)
- Monitor Patient's heart beat during maintenance of anesthesia(During maintenance of anesthesia)
- Test patient's blood pressure during anesthesia recovery period(During anesthesia recovery period)
- Monitor Patient's heart beat during anesthesia recovery period(during anesthesia recovery period)
- Observe chills reaction(At emerge from general anesthesia)
- To measure palinesthesia(At emerge from general anesthesia)
研究者
Yue Yun
Randomized, parallelled and double-blinded trial of small-dose dexmedetomidine effects on recovery profiles of supratentorial tumors patients from general anesthesia
China Medical University, China