Target-Controlled Infusion of Remifentanil Without Muscle Relaxant Allows Acceptable Surgical Conditions During Thoracotomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Modified surgical rating scale
研究概览
简要总结
Although the administration of muscle relaxation is essential standard of care for thoracic procedures, it could cause long-reversal times and postoperative residual curarization (PORC) increasing length of post-anesthesia care unit (PACU) stay and hospital costs. Sugammadex offers new perspectives to reduce the incidence of PORC. Unfortunately it is not available in many countries because of its significantly high cost. We hypothesized that the use of target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR) would be associated with comparable surgical conditions and reduced total costs compared with the use of neuromuscular blockers during thoracotomy.
After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane anesthesia with TCI remifentanil will be included in this prospective, randomized, single-blind, controlled study.
Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each group) throughout the procedure. Laryngoscopy and intubating conditions, intraoperative modified thoracic surgery rating scale (Table below), incidence of light anesthesia, and use of vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital stays, and total costs will be recorded.
详细描述
Administration of muscle relaxation is essential standard of care in thoracic surgery as it causes an improvement of surgical conditions. The concept of "Fast-track thoracic anesthesia" requires the use of either short or intermediate-acting nondepolarising neuromuscular blocking drugs, to provide a sufficient neuromuscular blockade during surgery and to restore the normal neuromuscular transmission immediately at the end of surgery.1
However, long-reversal times and postoperative residual curarization (PORC) are still a problem in 30%-60% of the anesthetized patients even with the use of new intermediate-acting neuromuscular blockers.2-3 PORC could cause aspiration of the lungs and respiratory failure4 after thoracic surgery that may prolong the post anesthesia care unit (PACU) and hospital stays.
Although, sugammadex, a modified gamma-cyclodextrin, offers new perspectives to reduce the incidence of PORC,4 it is not available in many countries because of its significantly high cost.5
Therefore, in fast-track cardiac surgery, it seems unnecessary to maintain paralysis by repetitive bolus injection or continuous infusion of neuromuscular blockers with overall surgeons' satisfaction.6
The use of remifentanil without muscle relaxants provides excellent intubating conditions and short recovery duration.7 The effective concentration range of remifentanil for tracheal intubation without muscle relaxant is 4.5-5.5 ng/ml.8 The use of non-muscle relaxant (NMR) anesthetic techniques using remifentanil with either propofol or sevoflurane allows early extubation after trans-sternal or video-assisted thymectomy in myasthenic patients.9-10
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical class (II-III)
- •elective open thoracotomy
排除标准
- •New York Heart Association class> II)
- •Forced vital capacity < 50% of the predicted values
- •Forced expiratory volume in 1 second < 50% of the predicted values
- •Hepatic diseases
- •Renal diseases.
- •Reactive airways.
- •Neuromuscular diseases.
- •Pregnancy
- •Increased risk of regurgitation
- •Anticipated difficult intubation
- •Body mass index >35 kg/m2
- •Electrolytes abnormalities
- •Acid base abnormalities
- •Repeat surgery
- •history of head and neck surgery
- •Preoperative circulatory support
- •Preoperative ventilatory support
- •Medications affecting the neuromuscular junctions
- •Family history of malignant hyperthermia
- •Allergy to any of the study drugs
研究组 & 干预措施
Muscle Relaxants (MR) group
Cisatracurium will be administered
干预措施: Muscle Relaxants (MR) group (Drug)
Non- Muscle Relaxants (NMR) group
No cisatracurium will be administered
干预措施: Non- Muscle Relaxants (NMR) group (Drug)
结局指标
主要结局
Modified surgical rating scale
时间窗: for 3 hours after start of surgery
A four-point ordinal scale adopted from the surgical rating scale of Martini et al.,ranging from 1 (extremely poor conditions) to 4 (optimal conditions). Extremely poor (Score 1) indicates that the surgeon is unable to work because of coughing, bucking, diaphragmatic contractions or movements, or the inability to spread or approximate the ribs during chest opening and closure, respectively, because of inadequate muscle relaxation; poor (Score 2) indicates that there is a visible field, but the surgeon is severely hampered by continuous muscle contractions, spontaneous movements of the surgical lung, or both that could cause hazard of tissue damage; good (Score 3) indicates that there is an acceptable field with sporadic muscle contractions causing some interference with the surgeon's work; excellent (Score 4) indicates a wide working field without any lung movement or muscle contractions.
次要结局
- Mean blood pressure(5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation)
- Train-of-four ratio(5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation)
- laryngoscopy conditions(1 min after laryngscopy)
- intubating conditions(1 min after intubation)
- Cost of medications(after surgery)
- Need for vasoactive drugs(for 3 hour during surgery)
- Recovery Times(for 1 hours after surgery)
- heart rate(5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation)