跳至主要内容
临床试验/NCT07831434
NCT07831434尚未招募不适用

Association Between Postoperative Residual Neuromuscular Block After Rocuronium Administration and Passive Smoke Exposure in Pediatric Patients Undergoing Dental Procedures

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
55
试验地点
1
主要终点
Incidence of Postoperative Residual Neuromuscular Block

研究概览

简要总结

Postoperative residual neuromuscular block (PRNB) may persist despite apparent clinical recovery from neuromuscular blockade and may increase the risk of postoperative respiratory complications. Quantitative neuromuscular monitoring is therefore important for identifying incomplete neuromuscular recovery. This prospective, single-center observational cohort study aims to determine the incidence of PRNB in pediatric patients undergoing dental procedures under general anesthesia with rocuronium and to evaluate the association between passive smoke exposure and PRNB. Children aged 2-12 years will undergo quantitative neuromuscular assessment using the TOF-Watch SX after clinical extubation and admission to the post-anesthesia care unit (PACU). PRNB will be defined as a train-of-four (TOF) ratio <0.9. The incidence of PRNB will be determined, and its association with passive smoke exposure and perioperative clinical variables will be evaluated.

详细描述

This is a prospective, single-center observational cohort study involving children aged 2-12 years undergoing elective dental procedures under general anesthesia in whom rocuronium is administered for neuromuscular blockade. The study is designed to determine the incidence of postoperative residual neuromuscular block (PRNB) after clinical extubation and to investigate whether passive smoke exposure is associated with an increased risk of PRNB.

Anesthetic management will be performed according to the study protocol. Following clinical recovery and extubation, patients will be transferred to the post-anesthesia care unit (PACU), where quantitative neuromuscular function will be assessed using a TOF-Watch SX monitor. Ulnar nerve stimulation and the adductor pollicis response will be used for train-of-four (TOF) monitoring. PRNB will be defined as a TOF ratio <0.9.

Passive smoke exposure will be assessed using information obtained from the parent or legal guardian, including the presence and number of smokers in the household, smoking by the primary caregiver, smoking inside the home, daily cigarette consumption, and the duration of the child's exposure. Participants will be classified according to the presence or absence of passive smoke exposure.

In addition to determining the incidence of PRNB, the study will evaluate the association between passive smoke exposure and PRNB, the relationship between TOF ratio and postoperative respiratory complications, and the effect of the interval between the last dose of rocuronium and TOF assessment on PRNB.

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
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-12 years
  • Scheduled to undergo dental procedures under general anesthesia
  • Administration of rocuronium as part of routine anesthetic management
  • Written informed consent obtained from a parent or legal guardian

排除标准

  • Known neuromuscular disease
  • Known allergy or contraindication to rocuronium
  • Use of medications known to significantly affect neuromuscular transmission
  • Severe hepatic or renal dysfunction
  • Inability to obtain reliable postoperative TOF measurements

研究组 & 干预措施

Passive Smoke Exposure

Children with passive smoke exposure as reported by the parent or legal guardian

干预措施: Passive Smoke Exposure (Other)

No Passive Smoke Exposure

Children without passive smoke exposure as reported by the parent or legal guardian

结局指标

主要结局

Incidence of Postoperative Residual Neuromuscular Block

时间窗: At admission to the post-anesthesia care unit (PACU), immediately after extubation

Percentage of participants with postoperative residual neuromuscular block (PRNB), defined as a normalized train-of-four (TOF) ratio \<0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.

次要结局

  • Association Between Passive Smoke Exposure and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio(At admission to the post-anesthesia care unit (PACU), immediately after extubation)
  • Association Between Postoperative TOF Ratio and Postoperative Respiratory Complications, Measured as an Odds Ratio(From admission to the post-anesthesia care unit (PACU) through PACU discharge)
  • Association Between Time Since the Last Rocuronium Dose and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio(At admission to the post-anesthesia care unit (PACU), immediately after extubation)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Metin İlteray Kıkılı

Anesthesiologist

Istanbul University - Cerrahpasa

研究点 (1)

Loading locations...

相似试验