The Effect of Oral Pregabalin on Epidural-induced Shivering and Epidural Characteristics in Gynecological Surgeries, a Prospective Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Shivering
研究概览
简要总结
- Background: The previous reports tried to reduce shivering and improve neuroaxial anesthesia characteristics by the systemic use of different drugs. This study was directed to evaluate the effect of pregabalin premedication on both shivering and epidural outcome data following single shot loading.
- Patients and Methods: Eighty patients, ASA grade I and II, undergoing surgeries under epidural anesthesia were studied. The patients were divided into two groups: Pregabalin group and Control group in which the patients received 150 mg of pregabalin and placebo capsules respectively sixty minutes prior to surgery. Following epidural loading, the onset and degree of shivering were compared between the two groups. Also, the epidural outcome including onset, level and duration were traced and compared. The perioperative hemodynamics, sedation scores, patient satisfaction and side effects were followed up and registered.
详细描述
After obtaining the ethical committee approval of Beni Suef University hospital, in Egypt and an informed consent from the patients, Eighty female patients with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing gynecological surgery (Posterior repair and transobturator transfixation) under epidural anesthesia, were enrolled in this randomized double -blind study in May 2018.
The patients were excluded from the study if ASA class was more than II, anticipated difficult epidural insertion or there was any contraindication to epidural anesthesia, if any patient developed wet or bloody tab, or the patients were under psychotropic or antiepileptic therapy.
The 80 Patients were randomly allocated into one of two groups (using sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist and given to the ward nurse) [40 patients in each group]:
- Pregabalin group (P), [n=40]: received pregabalin 150 mg capsules (Lyrica®,Pfizer) sixty minutes prior to the epidural insertion.
- Control group (C), [n=40]: received placebo capsules sixty minutes prior to epidural insertion.
Prior to administration of study drugs, mean arterial blood pressure (MAP), heart rate (HR), oxygen saturation (SpO2), and tympanic temperature (T temp) were taken as [baseline reading]. Upon reaching the operation theater, a second set of readings were taken [preoperative reading], together with sedation score using a 4 points "Modified Wilson" Sedation Scale [1=awake; 2=drowsy but arousable to command; 3= asleep but arousable to mild physical stimulation; and 4= asleep but not arousable to mild physical stimulation].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist and given to the ward nurse
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adults female patients (20 - 60 years old)
- •with an American society of Anesthegiologists physical status (ASA) I-II
- •undergoing gynecological surgery
排除标准
- •ASA class was more than II,
- •anticipated difficult epidural insertion
- •any contraindication to epidural anesthesia, if any patient developed wet or bloody tab, or the patients were under psychotropic or antiepileptic therapy.
研究组 & 干预措施
Pregabalin group (P)
received pregabalin 150 mg capsules (Lyrica®,Pfizer) sixty minutes prior to the epidural insertion.
干预措施: Pregabalin 150mg (Drug)
Control group (C)
received placebo capsules sixty minutes prior to epidural insertion.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Shivering
时间窗: starting from epiural injection, up to 60 minutes after epidural anesthesia
incidence of maximum shivering
- Shivering
时间窗: starting from epiural injection, up to 60 minutes after epidural anesthesia
incidence of positive shivering ,
次要结局
- Epidural characteristics(from epidural onset to starting feeling pain (approximately 90 minutes))
- - Epidural characteristics(from epidural injection till numbing sensation (approximately 10 minutes))
研究者
Tarel Al Menisy
Associate professor
Beni-Suef University
