Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study
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
- 否
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
Mehmet Burak Eşkin
Assistant professor
Gulhane School of Medicine
