Impact of Propofol vs Propofol-ketamine sedative regimen on lung atelectasis and diaphragm function in children undergoing magnetic resonance imaging: 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
- 150
- 试验地点
- 1
- 主要终点
- The incidence of pulmonary atelectasis determined by lung ultrasonography. Atelectasis is defined as a juxtapleural consolidation score (C score) greater than 1 in more than one region, as determined by the lung ultrasound examination
研究概览
简要总结
After obtaining due consent the patients are shifted into MRI suite, ASA standard monitors will be applied. Baseline Lung and diaphragm sonography will be performed by an experienced investigator who are blinded to the group allocation, using ultrasound system and baseline C score, totql lung score and diaphragm excursion noted.
The primary MRI anesthesia senior resident will open the sealed envelope and prepare the study drug as per the group allocation, who otherwise will have any involvement in this study. and the patients will receive either of the following sedative regimes:
Group A patients that is Propofol group participants will receive propofol and saline followed by a continuous infusion of propofol
Group B patients that is Propofol ketamine groupParticipants will receive propofol and ketamine followed by a continuous infusion of propofol .
The above MRI sedation protocol will be carried out by Anaesthesia consultant posted in MRI as per the group allocation and will not be a further part of the study. The ultrasonography will be performed by one of the investigators blinded to the study group in question. The video clip and images of the performed USG scan will be stored for review.
After MRI scan, all patients will be shifted to PACU and a repeat USG lungs and diaphragm will be performed and data on C score, Total lung score and Diaphragm excursion noted. Patients will be kept for monitoring in PACU for a minimum of 6 hours and then followed up from the day of MRI to 72 hours after MRI sedation by telephonic interview of parents at 24 hours,48 hours and 72 hours from the MRI scan. A pre established structured questionnaire designed to screen patients for any features of postoperative pulmonary complications will be used for the purpose. The parents would have been informed about the proposed telephonic interview and the questionnaire on the day of the Pre-anaesthetic assessment.
All participating patients, regardless of the study arm to which they are randomized, will be monitored and managed according to the general standard of care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I to II Elective MRI Under Deep Sedation.
排除标准
- •History of thoracic surgery
- •Associated pulmonary pathology eg.
- •atelectasis, pneumonia, pneumothorax, or pleural effusion based on preoperative chest roentgenogram or Ultrasound and CT chest when available 3.Current respiratory infection with fever greter than 38°C, purulent cough, yellowish nose discharge, or wheezing sound,
- •Airway abnormality
- •Allergy or contraindications for the study drugs
- •Duration of MRI more than 2hours
- •Patient refusal
- •Inability to obtain a pre sedation baseline USG scan.
结局指标
主要结局
The incidence of pulmonary atelectasis determined by lung ultrasonography. Atelectasis is defined as a juxtapleural consolidation score (C score) greater than 1 in more than one region, as determined by the lung ultrasound examination
时间窗: From starting of anaesthesia to lung Ultrasound in the postsedation period.
次要结局
- 1. Total lung score(2. Diaphragm excursion)
研究者
Shibani Padhy
Nizams Institute of medical sciences