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Effect of Ketamine Addition to Lidocaine in Rhinoplasty

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Inonu University

关键词

抽象

The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.

描述

In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.

日期

最后验证: 03/31/2013
首次提交: 03/27/2013
提交的预估入学人数: 04/07/2013
首次发布: 04/08/2013
上次提交的更新: 04/07/2013
最近更新发布: 04/08/2013
实际学习开始日期: 12/31/2012
预计主要完成日期: 01/31/2013
预计完成日期: 02/28/2013

状况或疾病

Nose Deformities, Acquired

干预/治疗

Drug: Group L (number of participants=30)

Drug: Group K (number of participants=30)

Drug: Group S (number of participants=30)

相 4

手臂组

干预/治疗
Active Comparator: Group L (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL lidocaine 2%, 1mg/kg into nasal cavity.
Drug: Group L (number of participants=30)
12 mL lidocaine 2% 1mg/kg
Active Comparator: Group K (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of 12 mL ketamine 0.5 mg/kg plus lidocaine 2% 1 mg/kg of the intranasal cavity.
Drug: Group K (number of participants=30)
ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
Placebo Comparator: Group S (number of participants=30)
After standard anesthesia induction and before surgery, patients will receive submucosal infiltration of saline 12 mL into intranasal cavity.
Drug: Group S (number of participants=30)
12 mL saline (0.9% isotonic solution)

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Patients scheduled for elective rhinoplasty operation under general anesthesia

- Patients with ASA (American Society of Anesthesiology) class I

- Patients between 18-50 years old

Exclusion Criteria:

- Age <18 and >50

- ASA > II

- Preexisting neurological or psychiatric illness

- Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)

- Having a history of chronic pain and receiving chronic analgesia therapy

- Having a history of drug abuse

结果

主要结果指标

1. Postoperative pain scores on the Visual Analogue Scale [24 hours]

Pain scores will examine with Visual analogue scale (VAS, 0-100) in the first 24 hours of postoperative period. The examination will repeated in different time period(5.min, 15.min, 30.min, 1 h, 2h,4.h, 6.h, 8.h, 16.h, 24.h). Patients that have VAS>40 will receive 1mg/kg tramadol.

次要成果指标

1. Patient satisfaction [24 hour]

At the end of postoperative 24 h, the patient satisfaction will examine by a score as (1 poor, 2 middle, 3 good, 4 perfect)

2. Analgesic demand [24 hour]

At the first day of postoperative period, analgesic requirement will record. When Visual analogue scale > 40, intravenous 1 mg/kg tramadol bolus will give.

其他成果措施

1. Number of participants with adverse effects as a measure of safety and tolerability [24 hour]

Sedation, nausea and vomiting, dizziness, and hallucination will examine as an adverse effect in all patients.

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