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临床试验/NCT05165641
NCT05165641已完成不适用

Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital

Avicenna Military Hospital0 个研究点目标入组 62 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
主要终点
Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital

研究概览

简要总结

Providing safe and efficient anesthesia and in a field hospital is a challenging situation. This study investigated the feasibility and safety of thoracic spinal anesthesia for small-incision open cholecystectomy in a deployed field hospital.

详细描述

This study was conducted in a field hospital deployed in a rural area of the middle Atlas in Morocco during the winters of 2016 and 2017. The Middle Atlas is a part of the Atlas mountain range which is usually blocked and isolated by snow during the winter. The hospital deployed was an inflatable tent hospital self-contained and self-sufficient. This field hospital included the following components: a patient's ward (sixty beds), an operating theater with one surgical table, a recovery room with 2 beds, a laboratory, an X-ray unit, a pharmacy, and several exams rooms.

After approval by the Ethical review board of Avicenna Military Hospital, Marrakech, Morocco (CERB7/2016), written informed consent was obtained from patients who agreed to participate in the study.

The inclusion criteria were: uncomplicated symptomatic cholelithiasis confirmed by preoperative ultrasound, age 18 years or older and American society of anesthesiologists (ASA) physical status I, II or III. Exclusion criteria were: patients with acute cholecystitis, suspected common bile duct stones, previous abdominal surgery, bleeding diathesis, spinal abnormality, and allergy to any drug used in the study.

Patients were interviewed and examined by an anesthesiologist in a preoperative visit several days before surgery. On arrival in the operating room the patient's non-invasive blood pressure, oxygen saturation, and heart rate were monitored. Heart rate and blood pressure were recorded every five minutes. Intravenous access was established in the forearm with an 18 Gauge catheter and patients received a preload with 10 ml/Kg of normal saline. Patients were given 1mg midazolam intravenously for anxiolysis and oxygen 2-3 l /min was administered by a nasal cannula. Cefazolin 2 g was injected as antimicrobial prophylaxis. Antiemetic prophylaxis was also carried out with dexamethasone 4 mg IV.

Spinal anesthesia was performed at a lower thoracic level with the patient in the sitting position. After local anesthesia with 1% lidocaine, the spinal puncture was done in the 10th thoracic intervertebral space (T 10) through a median approach. A 27 Gg pencil-point needle with an introducer was used (marquee). To identify T 10, the vertebra prominens (C7) was palpated and the spinous processes were palpated caudally. Two senior anesthesiologists performed all the spinal punctures. The progression of the spinal needle was cautious and soft. The effort was made to stop the needle progression just after the tactile perception of the dura mater. Once the flow of cerebrospinal fluid was obtained, 1.5 ml of hyperbaric bupivacaine 5mg/ml (=7.5 mg) mixed with 0.5 ml of fentanyl 50 µg/ml (= 25 µg) was injected and the spinal needle removed. Patients were asked to report any pain or paresthesia during the puncture. The patient was then placed in a supine horizontal position. The level of sensory block was assessed every 2 minutes (pinprick method). After an adequate sensory block was obtained (T4 - T 12), surgery was allowed to start. The nasogastric tube was not inserted unless the surgeon required it.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • uncomplicated symptomatic cholelithiasis
  • American society of anesthesiologists (ASA) physical status I, II, or III

排除标准

  • patients with acute cholecystitis
  • suspected common bile duct stones
  • previous abdominal surgery
  • bleeding diathesis
  • spinal abnormality
  • allergy to any drug used in the study

结局指标

主要结局

Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital

时间窗: intraoperatively

Patients' peroperative pain scores assessed on a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain)

Hemodynamic tolerance of segmental spinal anesthesia.

时间窗: intraoperatively

Heart rate (beats per minute): monitored and recorded every 5 minutes:

Respiratory safety of segmental spinal anesthesia.

时间窗: intraoperatively

Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.

次要结局

  • surgeon's satisfaction with anesthesia technique(intraoperatively)
  • patient satisfaction with anesthesia technique(24 hours postoperatively)
  • postoperative adverse effects(24 hours postoperatively)

研究者

发起方
Avicenna Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Younes Aissaoui, MD

Professor of anesthesia and intensive care medicine

Avicenna Military Hospital

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