Effects of Low-Dose Neuromuscular Blocking Agents on Perioperative Complications During Bronchoscopic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- The incidence rate of laryngeal spasm
研究概览
简要总结
The purpose of this clinical trial is to observe the use of low-dose muscle relaxants in bronchoscopy intervention surgeries, compared with no muscle relaxants, in terms of the satisfaction of tracheal tube insertion after anesthesia induction, the incidence of laryngospasm, the grading of intraoperative cough and movement, and the recovery of patients after surgery. The main questions it aims to answer are:
- How safe and feasible is the use of low-dose muscle relaxants in bronchoscopy intervention surgeries?
- Is the muscle relaxant regimen better than the no-muscle-relaxant regimen?
Participants will:
- During anesthesia induction, the experimental group will use low-dose muscle relaxants for anesthesia, while the control group will not use muscle relaxants for anesthesia.
- Record the satisfaction of mask ventilation and the incidence of laryngospasm.
详细描述
Objective
To investigate whether the prophylactic use of low-dose neuromuscular blocking agents, in addition to remimazolam combined with remifentanil for intravenous anesthesia, can reduce the incidence of difficult mask ventilation and laryngospasm during induction, and to systematically observe the effects of this regimen on intraoperative adverse reactions and the quality of postoperative recovery.
Methods: A total of 154 patients undergoing elective bronchoscopic procedures were randomly divided into two groups: a muscle relaxant group (n=77) and a no-muscle relaxant group (n=77). Anesthesia induction in the muscle relaxant group was achieved with intravenous lidocaine 0.5 mg/kg, remimazolam 0.2 mg/kg, remifentanil 3 μg/kg, and rocuronium 0.15 mg/kg. The no-muscle relaxant group received the same regimen, except rocuronium was replaced with an equal volume of normal saline. A suitably sized laryngeal mask airway was inserted using a standard technique in both groups. Anesthesia was maintained with a continuous infusion of remimazolam at 1 mg/kg/h and remifentanil at 0.25-0.5 μg/kg/min. The primary outcome measures were the grade of chest wall rigidity, the incidence of difficult mask ventilation, the incidence of SpO₂ <92% during mask ventilation, the incidence of laryngospasm, and the grade of coughing/body movement during bronchoscope insertion. Secondary outcome measures included the incidence of SpO₂ <92% during bronchoscope insertion, perioperative changes in blood pressure, heart rate, oxygen saturation, bispectral index, airway pressure, and end-tidal carbon dioxide partial pressure; laryngeal mask airway insertion parameters (time, number of attempts, and ease of insertion); intraoperative drug dosages; the incidence of intraoperative and postoperative adverse reactions; and the quality of postoperative recovery.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective electronic bronchoscopic interventional surgery;
- •Age 18 years or older;
- •American Society of Anesthesiologists (ASA) I-III;
- •The duration of bronchoscopic surgery >=20min;
- •Through pre-anesthesia assessment, the patient/family member has informed consent and signed the consent form;
- •The general clinical information of the patient is complete.
排除标准
- •Patients with predictable difficult airway;
- •Small mouth opening (<2 transverse fingers);
- •Combined with severe cardiovascular disease, abnormal liver and kidney function;
- •Morbidly obese patients with body mass index (BMI) greater than 35kg/m^2;
- •Has a history of gastroesophageal reflux disease.
- •High risk of reflux aspiration;
- •Those who have a history of abnormal surgical anesthesia recovery in the past;
- •Patients with mental illness and previous allergies to conventional anesthetic drugs.
研究组 & 干预措施
normal saline
During the induction of anesthesia, rocuronium is not used for anesthesia.
干预措施: Normal Saline (Placebo) (Drug)
normal saline
During the induction of anesthesia, rocuronium is not used for anesthesia.
干预措施: Remimazolam Tosilate (Drug)
normal saline
During the induction of anesthesia, rocuronium is not used for anesthesia.
干预措施: Lidocaine Intravenous Infusion (Drug)
normal saline
During the induction of anesthesia, rocuronium is not used for anesthesia.
干预措施: Remifentanil (Drug)
rocuronium bromide
Using rocuronium for anesthesia during the induction phase of anesthesia.
干预措施: Lidocaine Intravenous Infusion (Drug)
rocuronium bromide
Using rocuronium for anesthesia during the induction phase of anesthesia.
干预措施: Remimazolam Tosilate (Drug)
rocuronium bromide
Using rocuronium for anesthesia during the induction phase of anesthesia.
干预措施: Remifentanil (Drug)
rocuronium bromide
Using rocuronium for anesthesia during the induction phase of anesthesia.
干预措施: Rocuronium (0.15mg/kg/body mass) (Drug)
结局指标
主要结局
The incidence rate of laryngeal spasm
时间窗: At the beginning of the operation
Observe the degree of glottic opening (grade I: glottis opens well; grade II: glottis opens \>⅔, mild laryngospasm; grade III: glottis opens ⅓-⅔, moderate laryngospasm; grade IV: glottis opens ≤⅓ or is completely closed, severe laryngospasm).Grades III and IV were defined as laryngospasm.
次要结局
- Severe cough(Intraoperative)
- Severe body movement(Intraoperative)
- Emergence time(Perioperative period)
- Recovery time(Perioperative period)
- Time of laryngeal mask placement(During the process of anesthesia induction)
- The incidence of oxygen desaturation (SpO₂ < 92%) during mask ventilation(during anesthesia induction)
- Tachycardia(Intraoperative)
- Bradycardia(Intraoperative)
- Grading of body movement during bronchoscope insertion(At the beginning of the operation)
- Grading of chest wall rigidity(During the process of anesthesia induction)
- Difficult facemask ventilation(During the process of anesthesia induction)
- The incidence rate of choking cough when the bronchoscope first enters the trachea(At the beginning of the operation)
- Dosage of Anesthetic Drugs(Perioperative period)
- The satisfaction of the operating physician(30 minutes after surgery)
- Anesthesiologist satisfaction(30 minutes after surgery)
- Patient satisfaction(30 minutes after surgery)
- Hypotension(Intraoperative)
- Hypertension(Intraoperative)
- Airway rescue interventions(Intraoperative)
- Peak airway pressure > 30 cmH₂O(Intraoperative)
- Incidence of SpO₂ < 92% during bronchoscope insertion(at the start of surgery)
- Shortness of breath(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- Procedure time(Perioperative period)
- Anesthesia time(Perioperative period)
- The severity of postoperative sore throat(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- Dysphagia(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- Nausea(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- Number of laryngeal mask placements(During the process of anesthesia induction)
- Vomit(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- Is it easy to insert the laryngeal mask?(During the process of anesthesia induction)
- heart rate(The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours))
- oxyhemoglobin saturation(The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours))
- Bispectral index(The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours))
- airway peak pressure(The period from the start of anesthesia induction to the time when the patient leaves the operating room after the surgery is completed (up to 4 hours))
- Airway platform pressure(The period from the start of anesthesia induction to the time when the patient leaves the operating room after the surgery is completed (up to 4 hours))
- Carbon dioxide at the end of breathing(The period from the start of anesthesia induction to the time when the patient leaves the operating room after the surgery is completed (up to 4 hours))
- Bloating of stomach(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- hoarseness(When the patient regained consciousness (assessed up to 30 minutes after surgery))
- blood pressure(The time from when the patient enters the operating room until the patient finishes the surgery and leaves the operating room (up to 4 hours))
研究者
Shi xiaoqian
Graduate student
Harbin Medical University