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临床试验/NCT04301232
NCT04301232已完成不适用

Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study

Gulhane School of Medicine1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2018年5月10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
122
试验地点
1
主要终点
Duration of the surgery

研究概览

简要总结

122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Primary outcome measures were PACU bypass rates and hospital discharge times. Secondary outcome measure was to compare discharge scoring systems for PACU bypass assessment: modified Aldrete Scoring System (mASS), White's Fast-Tracking Scoring System (WFTSS), and SPEEDS criteria

详细描述

After obtaining hospital's ethics committee approval (University of Medical Sciences, Gülhane Training and Research Hospital- Date: 06/05/2018; No: 18/148) and written informed consents obtained from patients, 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . After anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. After extubation, patients were evaluated using mASS, WFTSS and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;). Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU). All patients were followed in the ward until hospital discharge. IV tramadol PCA (Patient -Controlled Analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 IV with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. Pain was evaluated using Visual Analogue Scale (VAS) with 2 hours intervals and IV pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when VAS was >3. PONV was treated using IV 4 mg ondansetron. Discharge from hospital was evaluated using Post Anesthetic Discharge Scoring System (PADSS), . Patients with a PADSS score ≥ 9 were discharged from the hospital by the escort of their relatives.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • ASA (American Society of Anesthesiologists) physical status I-II patients
  • elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia
  • minimal risks for perioperative bleeding and airway safety

排除标准

  • patient's refusal
  • urgent surgery,
  • regional anesthesia,
  • history of previous lumbar surgery
  • difficult ventilation and intubation,
  • treatment for chronic pain
  • obstructive sleep apnea,
  • morbid obesity (BMI≥40 kg/m2)
  • allergy to drugs

结局指标

主要结局

Duration of the surgery

时间窗: at the end of the surgery

the period (minutes) from the beginning of the surgery to the end of surgery

Time to hospital discharge

时间窗: 1 weeks after discharge from the hospital

The period (hours) from hospital admission to hospital discharge.

patients who were eligible for fast-tracking

时间窗: through study completion, an average of 2 weeks

number patients who were eligible for fast-tracking

factors preventing

时间窗: through study completion, an average of 2 weeks

factors preventing fast-tracking and/or discharge from hospital in outpatient setting

PACU( post-anesthesia care unit) by-pass rate

时间窗: 1 weeks after discharge from the hospital

The period (minutes) from admission to post-anesthesia care unit to discharge from the clinic

time to PACU care in group PACU

时间窗: 1 weeks after discharge from the hospital

duration (minutes) of PACU care for patients in group PACU

time to extubation

时间窗: 1 hour after extubation

the period (minutes) from the end of surgery until extubation

Time to PACU by-pass in group FT

时间窗: 1 weeks after discharge from the hospital

time(minutes) to be eligible for PACU by-pass in group FT according to scoring systems

patients who were discharged from hospital

时间窗: through study completion, an average of 2 weeks

number patients who were discharged from hospital with respect to outpatient surgery (discharge time \< 24 hours)

次要结局

未报告次要终点

研究者

发起方
Gulhane School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Burak Eşkin

Assistant professor

Gulhane School of Medicine

研究点 (1)

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