Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- First-attempt intubation success without physiological instability
研究概览
简要总结
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.
This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.
A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.
详细描述
Neonatal tracheal intubation is performed in approximately 15-20% of NICU admissions. First-attempt success rates are approximately 49%, and adverse tracheal intubation-associated events (TIAEs) occur in up to 18% of procedures, with severe oxygen desaturation in up to 48% (NEAR4NEOS registry, Foglia et al., 2019). Premedication with neuromuscular blocking agents has been independently associated with a 62% reduction in adverse events (aOR 0.38; 95% CI 0.25-0.57).
Rocuronium is a non-depolarizing neuromuscular blocking agent with rapid onset, stable hemodynamic profile, and full reversibility with sugammadex, making it a safe choice for neonatal premedication.
The NEORIN trial will enroll 102 newborns (51 per group) with postnatal age ≤28 days or corrected gestational age <44 weeks, requiring non-emergent tracheal intubation. Randomization will be performed in variable-sized permuted blocks (4 and 6), with allocation concealment through sequential opaque sealed envelopes.
Intervention group: fentanyl 1 mcg/kg IV + rocuronium 0.6 mg/kg IV. Control group: fentanyl 1 mcg/kg IV + saline placebo (equivalent volume). Sugammadex is available at the bedside throughout the study as a mandatory safety requirement.
The primary composite outcome is first-attempt intubation success without physiological instability, defined as correct tube placement on the first laryngoscopy attempt confirmed by colorimetric CO2 detection, with no SpO2 drop >20% from baseline and no bradycardia (HR <100 bpm). All procedures will be video-recorded for blinded outcome assessment.
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)
盲法说明
Complete masking is not feasible because rocuronium produces clinically detectable neuromuscular blockade. Partial masking is adopted: the primary outcome assessor, who reviews video recordings, and the data analyst are blinded to group allocation. The intubating physician is aware of the allocated group.
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <44 weeks
- •Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)
- •Informed consent signed by legal guardians
排除标准
- •Upper airway malformations
- •Use of neuromuscular blocking agent in the 24 hours prior to enrollment
- •Known hypersensitivity to fentanyl or rocuronium
- •Severe hemodynamic instability (ongoing shock)
- •Anticipated difficult airway (micrognathia, cleft palate, or similar)
- •Cyanotic congenital heart disease with critical instability
- •Neonatal abstinence syndrome
- •Concurrent enrollment in another interventional clinical trial
研究组 & 干预措施
Fentanyl Only
Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.
干预措施: Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. (Drug)
Fentanyl + Rocuronium
Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation.
干预措施: Rocuronium Bromide 10 MG/ML (Drug)
Fentanyl Only
Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.
干预措施: Rocuronium Bromide 10 MG/ML (Drug)
结局指标
主要结局
First-attempt intubation success without physiological instability
时间窗: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Composite outcome defined as correct endotracheal tube placement on the first laryngoscopy attempt, confirmed by colorimetric CO2 detection, with no SpO2 drop greater than 20% from baseline and no bradycardia (heart rate below 100 bpm) of any duration. A new attempt is defined as removal and reinsertion of the laryngoscope blade into the oral cavity.
次要结局
- Total number of intubation attempts(During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes))
- Procedure duration(From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes))
- Severe oxygen desaturation(During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes))
- Bradycardia during intubation(During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes))
- Need for additional maneuvers(During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes))
- Medication-related adverse events(During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes))
- Knowledge and barriers to neuromuscular blocking agent use(At the time of enrollment, before the intubation procedure, assessed once per participant)
研究者
Jefferson Pereira Guilherme
Neonatologist; Coordinator of Pediatric Residency Program; PhD Candidate
UEA - Universidade Do Estado Do Amazonas