Enhanced Recovery After Lumber Laminectomy Using Combined Epidural and General Anesthesia With Tolerable Endotracheal Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence of successful PACU bypass
研究概览
简要总结
Now, enhanced recovery after surgery (ERAS) is considered an essential goal to improve patient satisfaction, increase surgical workflow rate and facilitate performing different surgical procedures, including lumber laminectomy, on an ambulatory base. Different ERAS protocols have been applied and succeeded to improve recovery profile after colonic, rectal, gastric, urologic, biliary, pancreatic, and gynecologic procedures. Up to our knowledge, it is the 1st trial that will investigate the effect of combining single shot epidural blockade and general anesthesia (GA) using tolerable endotracheal tube (TET), as components for ERAS protocol for patients undergoing lumber laminectomy, on postoperative recovery profile. so the current study will be done to assess if Single shot epidural blockade and GA using TET, for patients undergoing lumber laminectomy, can enhance their postoperative recovery.
详细描述
The study will be carried out at anesthesia and surgical intensive care department -Zagazig University Hospitals. Patients of both sexes, assigned to a single or double level lumbar laminectomy or discectomy, will be included in the study. all patients will be preoperatively evaluated according to standard local protocol. patients, who will not be excluded, will be assigned to one of two groups: Group I (control group) patients who will undergo standard general anesthetic technique and Group II (combined general/ epidural anesthesia group (CGEA)) patients will undergo single shot epidural analgesia [by bupivacaine (15 ml with 0.25% concentration)] followed by induction of standard general anesthesia (GA) using tolerable endotracheal tube (TET)
Both groups will be compared as regard:
- Patient recovery in the form of time to extubation, , time to achieving modified aldrete score ≥ 9 , duration of post-anesthesia care unit (PACU) stay and incidence of PACU bypass.
- Patients' satisfaction, time to Post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9 and incidence of hospital re-admission
- Intra operative hemodynamic stability, blood loss, operative time and surgeon's satisfaction.
- Postoperative pain scores and analgesic requirements.
Sample size was calculated using Epi Info 6, based on expected time to modified Aldrete score ≥ 9 in group I 13.1± 3.7 in group GA and in group II 7.9 ± 3.2 , confidence interval 95% and power of test 80%, to be 32. Eight patients will be added to compensate for dropout, so the total number of patients will be 40 patients.
All data will be collected, tabulated and statistically analyzed using SPSS 20.0 for windows (SPSS Inc., Chicago, IL, USA) and MedCalc 13 for windows (MedCalc Software bvba, Ostend, Belgium). According to the type of data qualitative data will be represented as number and percentage, parametric quantitative data will be represented by mean ± standard deviation (SD), non-parametric data will be presented as median and range and the following tests were used to test differences for significance and association of qualitative variable by Chi square test (X2). Differences between quantitative multiple by student t-test or Mann Whitney test as appropriate. P value was set at <0.05 for significant results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists (ASA) grade I-II
- •body mass index (BMI) < 30 kg/m2
- •assignment to a single or double level lumbar laminectomy or discectomy
排除标准
- •Patient's refusal of the procedure
- •local infection at site of catheter insertion
- •recurrent disc surgery, emergency surgery
- •coagulopathies
- •hemoglobin <8 g/dl
- •history of stroke or psychiatric disease
- •baseline neurological deficit
- •active upper respiratory tract infections
- •history of either laryngeal / tracheal surgery or pathology
- •uncontrolled hypertension or diabetes mellitus (DM), cardiac, pulmonary, hepatic or renal dysfunction
- •any contraindication for study technique or medications
- •being on regular steroids, opioid analgesics or alpha 2 agonists.
研究组 & 干预措施
control group, group I
standard general anesthetic (GA) technique
干预措施: standard general anesthetic technique, control group, group I (Procedure)
Epidural /GA using TET group, group II
patients will undergo a single shot epidural bupivacaine (15 ml with 0.25% concentration) followed by a standard general anesthetic technique in which the trachea was intubated using tolerable endotracheal tube (TET)
干预措施: (Epidural /GA using tolerable endotracheal tube (TET) group, group II (Procedure)
结局指标
主要结局
incidence of successful PACU bypass
时间窗: immediately before postoperative patient transfer out from the operating room
number of patients who will achieve a modified Aldrete score ≥ 9 before PACU admission. modified aldrete score (0- 10) higher score is better score
Time to achievement of phase I recovery criteria
时间窗: the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes
time to achievement of modified Aldrete score ≥ 9 after GA or CGEA. modified aldrete score (0- 10) higher score is better score
次要结局
- Time to achievement of phase II recovery criteria(the period of time (hours) starting from endotracheal extubation to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. estimated period of time 48 hours)
- incidence of persistant coughing or agitation on emergence from GA(occuring after neuromuscular reversal up to 20 mins after extubation)
- Time to extubation(the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes)
- patient's rating of perioperative satisfaction(immediately before hospital discharge (after the 1st postoperative 24- 48 hrs))
研究者
Abeer M Elnakera, MD
principle investigator
Zagazig University