A Comparative Evaluation of a Novel Technique for Bronchoscopy Guided Tracheobronchial Foreign BodyRemoval in Children-A Randomised Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.To compare the effect on intra-procedure and post-procedure hemodynamics
研究概览
简要总结
30 patients will be randomly divided into 2 groups. Patients will be premedicated with 0.05 mg/kg and glycopyrrolate 10 mcg/kg.Induction will be done in both groups with fentanyl 2 mcg/kg and propofol 1-2 mg/kg in titrated dose before the start of procedure.
Group A - Patients will be nebulized with 2ml of 2% lignocaine for 10-15 minutes in preoperative room before induction. After induction, transtracheal block will be done with 1 ml of 2% plain lignocaine 10 minutes prior to procedure.
Group B - Nebulisation and airway block will done with normal saline for blinding purpose.
Immediately followed by infusion of propofol @50-150 mcg/kg/min for maintenance anesthesia. We will use rescue propofol intermittently depending upon the patients’ requirements. Rigid bronchoscopy will be performed by pediatric surgeons in all cases . HR, SPO2 and NIBP will be recorded continuously every 3 minutes throughout the procedure and patient will be observed for any event of desaturation or other adverse effects. All patients will be maintained on the spontaneous ventilation. After completion of procedure and stopping anesthetics, we will note the time duration of return to full consciousness and baseline saturation with any eventful episodes. To monitor recovery of consciousness at the end of procedure , MOAA(Modified Observers Assessment of Alertness/Sedation) scale will be used .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA grade I to II 2.Recent H/O of tracheobronchial foreign body aspiration 3.Parents giving consent for participation in the study.
排除标准
- •1.Bronchoscopy through tracheostomy 2.Anterior neck swelling 3.Known allergy to local anesthetics 4.Renal, hepatic, or cardiovascular dysfunction, neurological disorders 5.Mental retardation or delayed milestones 6.Suspected coagulopathy 7.Parents refusal to participate in the study.
结局指标
主要结局
1.To compare the effect on intra-procedure and post-procedure hemodynamics
时间窗: Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
(Heart Rate, Non-Invasive Blood Pressure) and oxygen saturation.
时间窗: Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
2.Total dose of propofol used during procedure in both the groups.
时间窗: Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
3.Post-procedure recovery
时间窗: Heart rate,Non-invasive blood pressure and saturation will be recorded continuously every 3 minutes throughout the procedure and till return of consciousness.
次要结局
- To look for complications encountered in such procedures like airway intervention, bronchospasm, laryngospasm, vocal cord injury and laryngeal or subglottic odema in both groups.(Complications noted from start of bronchoscopy till completion of procedure and return of consciousness every 5 minutes)