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临床试验/NCT02988050
NCT02988050已完成不适用

Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery

Menoufia University0 个研究点目标入组 60 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Patients Satisfaction

研究概览

简要总结

Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean arterial blood pressure, oxygen saturation, and side effects such as respiratory depression, nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.

详细描述

After approval from the ethics committee of Menoufia University Hospitals and informed written consent, the present study was conducted on sixty patients of both sexes. Patients' age was between 18-50 years, American society of anesthesiologists (ASA) I and II and scheduled for awake craniotomy for treatment of epilepsy. Exclusion criteria included patients with history of allergy to any of the drugs used for the study, patients with alcohol or substance abuse, pregnant females, patients with mental instability, morbid obese patients, and patients with liver, kidney, or cardiac comorbidities.

Patients were randomly allocated using computerized software into two groups, thirty patients in each group to receive intra-operative either propofol-dexmedetomidine (PD group) or propofol-remifentanil (PR group) intravenous infusion. All patients received their routine treatment for epilepsy at their scheduled time before surgery. All patients were fully monitored intra-operatively for heart rate, non-invasive blood pressure, oxygen saturation, respiratory rate, and bi-spectral index (BIS). Oxygen was supplied to all patients via nasal cannula peri-operatively.

Anaesthesia was achieved by regional scalp block and IV sedation. Regional blockade of the scalp was performed using bupivacaine 0.5% and 2% lidocaine with epinephrine 1/200.000. The branches of the cranial nerves blocked were supratrochlear, supraorbital, auriculotemporal, greater and lesser occipital, great auricular, zygomatic, and infraorbital nerves. Supplemental local anesthetic solution was used to infiltrate along the incision lines prior to skin incision. During craniotomy, a mixture of 0.25% bupivacaine and lidocaine1% without epinephrine was used to anesthetize the dura mater. The maximum dose of lidocaine used did not exceed 4.5 mg kg -1 and for bupivacaine 3 mg kg -1.

All patients received propofol 1% with a starting intravenous infusion dose of 250 μg kg-1 min-1 for 15 min and then basal infusion dose at 50 μg kg-1min-1. Sedation was achieved for group PD by a combination of propofol and dexmedetomidine with a starting infusion dose of 1ug kg-1 hr -1 for 15 min, and then titrated down to 0.2μ g kg-1 hr-1.

In PR group, IV sedation was achieved by a combination of propofol and remifentanil at an initial bolus dose of 0.5 μg.kg-1 over 60 seconds and then a basal infusion of 0.1μg kg-1 min1. Insufficient sedation in both groups was treated with boluses of 250 μg kg-1 propofol. The total amount of propofol used in both groups was recorded.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients require conscious sedation for epilepsy surgery

排除标准

  • Patients refusal, allergy to drugs used, and uncooperative patients.

研究组 & 干预措施

Propofol-dexmedetomidine

Other

Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Dexmedetomidine (Drug)

Propofol-dexmedetomidine

Other

Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Propofol (Drug)

Propofol-dexmedetomidine

Other

Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Bupivacaine (Drug)

Propofol-dexmedetomidine

Other

Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Lidocaine (Drug)

Propofol-dexmedetomidine

Other

Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Epinephrine (Drug)

Propofol-remifentanil

Other

Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Remifentanil (Drug)

Propofol-remifentanil

Other

Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Propofol (Drug)

Propofol-remifentanil

Other

Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Bupivacaine (Drug)

Propofol-remifentanil

Other

Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Lidocaine (Drug)

Propofol-remifentanil

Other

Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)

干预措施: Epinephrine (Drug)

结局指标

主要结局

Patients Satisfaction

时间窗: 1 hour after the operation

Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.

次要结局

未报告次要终点

研究者

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

Dr Ezzeldin Ibrahim

Assistant Professor in anaesthesia, intensive care, and pain medicine

Menoufia University

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