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临床试验/NCT03386565
NCT03386565已完成不适用

Effect of Intraoperative IV Lidocaine Infusion on Intraoperative Isoflurane Requirements

Assiut University0 个研究点目标入组 50 人开始时间: 2016年10月2日最近更新:
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
50
主要终点
effect of intraoperative IV lidocaine infusion on intraoperative end tidal isoflurane concentration

研究概览

简要总结

Fifty patients were included in the study, divided into two equal groups (25 in each), underwent spinal fusion surgery.Control group: received normal saline.

Lidocaine group: received lidocaine 2.0 mg/kg slowly IV before induction of anesthesia, followed by lidocaine IV infusion at a rate of 2.5 mg/kg/hr until the end of surgery. We evaluated the end-tidal isoflurane concentration required to maintain AAI index in the range of 20-25 during adult spinal fusion surgery.

详细描述

This prospective, double-blinded, randomized study was carried out in Assiut University Hospitals, after approval by the local research ethics committee of Assiut Faculty of Medicine, Egypt. Informed consent was taken from each patient.

Patients were randomly allocated into two groups of equal size to receive either 0.9% sodium chloride infusion group 1 (CG), or lidocaine infusion group 2 (LG). Randomization was performed using G1 and G2 registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study. G1 patients (n = 25) were received 10 mL of 0.9% sodium chloride slowly IV just before induction of anesthesia, then infused through 50 mL syringe as lidocaine, and G2 patients (n = 25) were received a loading dose of lidocaine 2 mg ̸ kg (maximally 200 mg) slowly IV just before induction of anesthesia, then the lidocaine infusion started immediately after positioning at a rate of 2.5 mg ̸ kg/h until the end of the procedure (50 mL syringe contained 25 mL 2.0% lidocaine i.e., 500 mg lidocaine plus 25 mL normal saline). Both syringes (10 mL for loading dose and 50 mL for maintenance IV infusion) were labelled by the case number and prepared by another anesthesiologist who did not share in anesthesia.

Anesthesia technique: Patients were monitored with continuous electrocardiography, pulse oximetry and intermittent non-invasive blood pressure measurements every 5 min. Capnography, end-tidal isoflurane concentration (Et-Iso) via AVANCE CS2 Datex-Ohmeda, Inc. USA, and auditory evoked potential monitor (AEP monitor 2 Dia Trade medical engineering) also attached to the patient (one AEP electrode was placed on the center of the forehead, one on the temple, and one behind the left ear over the mastoid bone).

General anesthesia was induced by propofol 2.5 mg ̸ kg and cisatracurium 0.15 mg ̸ kg to facilitate endotracheal intubation. Patients were then assigned to two groups by closed-envelope randomization. In both groups, anesthesia was maintained with isoflurane in oxygen/air mixture at sufficient concentration to maintain AAI index in the range 20-25, and mean blood pressure within 25% of the baseline value. All patients were received 60 mg ketorolac (ketolac) slowly IV after induction of anesthesia, and fentanyl 1.5 µg ̸ kg IV before skin incision and 0.5 µg ̸ kg given IV after 45 min. Reversal of residual muscle relaxant was done using neostigmine and atropine at the end of the operation.

Data collection: Demographic and surgical data include: Age, gender, weight, height, duration and type of surgery, in addition to Et-Iso.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

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

  • Adult patients underwent spinal fusion surgery ASA I, II and III

排除标准

  • History of epilepsy hearing disorders known allergy to lidocaine BMI > 35 significant cardiac diseases significant renal diseases liver dysfunction substance abuse chronic opioid use

研究组 & 干预措施

control group

Active Comparator
  • Sodium chloride solution 10 mL IV just before induction of anesthesia
  • IV infusion during the surgery

干预措施: sodium chloride solution (Drug)

lidocaine group

Active Comparator
  • lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia
  • IV infusion during the surgery

干预措施: Lidocaine (Drug)

结局指标

主要结局

effect of intraoperative IV lidocaine infusion on intraoperative end tidal isoflurane concentration

时间窗: every 15 minutes from induction of anesthesia until 90 minutes intraoperative.

using gas analyzer for determination of end tidal isoflurane concentration (%) (ET-Iso) needed to maintain AAI index in the range 20-25.

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

Mohamed galal aly

Assistant Professor

Assiut University

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