Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function After Thoracoscopic Lung Resection: A Multicenter, Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to 1 Hour Postoperatively
研究概览
简要总结
Residual neuromuscular blockade (NMB) after general anesthesia increases the risk of postoperative respiratory complications (atelectasis, pneumonia, re-intubation) and delays pulmonary function recovery. Sugammadex, a γ-cyclodextrin that directly encapsulates rocuronium, reverses NMB rapidly and completely without cholinergic side effects, whereas neostigmine requires co-administration of an antimuscarinic and may leave residual blockade. In this multicenter, randomized, double-blind, controlled trial, 240 adult patients (ASA I-III) undergoing elective thoracoscopic lung resection (≤ 1 segment) will be randomized 1:1 to receive sugammadex (2 mg/kg) or neostigmine (0.03 mg/kg) + atropine (0.015 mg/kg) at the end of surgery. The primary endpoint is the percent decline in forced expiratory volume in 1 second (FEV₁) at 1 hour post-extubation compared to preoperative baseline; a ≥ 5% improvement with sugammadex is hypothesized. Secondary endpoints include FEV₁ at days 1-3, pain scores, opioid consumption, gastrointestinal recovery, quality of recovery (QoR-15), neuromuscular monitoring (TOF ratio), and incidence of postoperative pulmonary and surgical complications.
详细描述
Detailed Description:
Background: Thoracoscopic lung surgery requires general anesthesia with double-lumen endotracheal intubation and muscle relaxants to facilitate lung isolation and surgical exposure. Residual neuromuscular blockade after surgery can cause complications such as airway obstruction, atelectasis, pneumonia, prolonged PACU stay, and reduced patient satisfaction. Neostigmine, a commonly used acetylcholinesterase inhibitor, reverses neuromuscular blockade by increasing acetylcholine but may cause cholinergic side effects, requiring atropine co-administration. Sugammadex, a γ-cyclodextrin compound, encapsulates and inactivates rocuronium directly, reversing blockade without affecting cholinergic receptors and avoiding related adverse events. Sugammadex can also shorten operation time and improve turnover efficiency in thoracoscopic surgery.
Purpose: This study aims to compare the effects of sugammadex and neostigmine on early postoperative pulmonary function recovery in patients undergoing thoracoscopic lung resection, providing reliable clinical data to improve surgical management and enhance recovery.
Design: Patients planned for unilateral thoracoscopic lung segmentectomy will be randomized 1:1 to receive either sugammadex or neostigmine plus atropine for reversal of rocuronium-induced neuromuscular blockade at the end of surgery. Pulmonary function will be assessed using a portable spirometer before surgery and at postoperative 1 hour, 1 to 3 days, or before discharge. Other outcomes including postoperative pain, opioid consumption, gastrointestinal recovery, incidence of nausea/vomiting, quality of recovery (QoR-15 scale) will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind masking is implemented for participants and investigators to minimize bias. At the end of surgery, an independent anesthesia nurse prepares the study drug (sugammadex 2 mg/kg or neostigmine 0.03 mg/kg plus atropine 0.015 mg/kg) diluted in normal saline to a total volume of 10 mL in identical syringes, ensuring that the administering anesthesiologist and other study personnel remain blinded to the group assignment. Participants are also unaware of the assigned reversal agent. Blinding is maintained throughout the postoperative follow-up period, with unblinding reserved for emergencies or serious adverse events as per protocol.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective unilateral thoracoscopic partial lung resection, with expected resection not exceeding one lung segment.
- •Age between 18 and 80 years.
- •American Society of Anesthesiologists (ASA) Physical Status classification I-III.
排除标准
- •Contraindications to drug use, such as history of allergy, epilepsy, angina, ventricular tachycardia; contraindicated in patients with mechanical intestinal obstruction or urinary tract obstruction; contraindicated in cases of arrhythmia, bradycardia (<50 beats per minute), hypotension, or increased vagal tone; contraindicated in patients currently using depolarizing muscle relaxants (e.g., succinylcholine).
- •Inability to correctly cooperate with portable lung function testing.
- •Hepatic or renal insufficiency.
- •Pregnancy, lactation, potential for pregnancy, or planning pregnancy.
- •Preoperative history of drug abuse or addiction.
- •Second surgery during postoperative hospitalization.
- •Patients who refuse to participate.
- •Other situations deemed inappropriate by the investigators shall be accompanied by a statement of the reasons.
研究组 & 干预措施
Sugammadex Group
Participants in this experimental arm receive sugammadex (2 mg/kg IV) for reversal of rocuronium-induced neuromuscular blockade at the end of unilateral thoracoscopic lung segmentectomy surgery. The drug is prepared by an independent anesthesia nurse, diluted in normal saline to 10 mL, and administered when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This arm includes 120 participants randomized in a 1:1 ratio. Postoperative assessments focus on pulmonary function recovery, pain, and complications.
干预措施: Sugammadex (Drug)
Neostigmine Group
Participants in this active comparator arm receive neostigmine (0.03 mg/kg IV) plus atropine (0.015 mg/kg IV) for reversal of rocuronium-induced neuromuscular blockade at the end of unilateral thoracoscopic lung segmentectomy surgery. The drugs are prepared by an independent anesthesia nurse, diluted in normal saline to 10 mL, and administered when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This arm includes 120 participants randomized in a 1:1 ratio. Postoperative assessments focus on pulmonary function recovery, pain, and complications.
干预措施: Neostigmine (Drug)
结局指标
主要结局
Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to 1 Hour Postoperatively
时间窗: Preoperative (baseline, within 7 days before surgery) and 1 hour postoperative.
The percentage decline in FEV1 (measured using a portable spirometer) at 1 hour after unilateral thoracoscopic lung segmentectomy surgery, compared to the preoperative baseline value. FEV1 represents the volume of air exhaled in the first second of a forced expiratory maneuver. The decline is calculated as \[(preoperative FEV1 - postoperative FEV1) / preoperative FEV1\] × 100%. A smaller decline indicates better early postoperative pulmonary function recovery.
次要结局
- Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to Later Postoperative Time Points(Preoperative (baseline, within 7 days before surgery) and postoperative day 1-3 or before discharge.)
- Postoperative Pain Score(Postoperative 1 hour and postoperative day 1-3.)
研究者
Shiyou Wei
Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China