Exploring Heart Rate Variability and Pupillometry as Predictors of Sedation Depthin Dexmedetomidine Sedation in Non-Operating Room Anaesthesia (NORA) Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To evaluate the changes in HRV as a response to dexmedetomidine administration in NORA settings
研究概览
简要总结
This prospective observational study aims to evaluate whether heart rate variability and pupillometry can serve as reliable predictors of sedation depth in adult patients receiving dexmedetomidine sedation in non-operating room anaesthesia (NORA) settings. The study will include patients undergoing procedures such as MRI or minor interventions outside the operating room where dexmedetomidine is used for conscious sedation. Standard sedation scores such as the Richmond Agitation Sedation Scale (RASS) will be used as clinical reference. Physiological parameters including heart rate variability and pupil size will be recorded at predefined time points during sedation. The correlation between these objective parameters and clinical sedation scores will be analyzed to assess their predictive value. The study aims to contribute to safer and more individualized sedation practices in NORA environments.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Paediatric and Adults aged 2 to 70 years.
- •Scheduled for a procedure requiring sedation with dexmedetomidine in a NORA setting.
排除标准
- •Patients with pre-existing cardiovascular, neurological, or ocular conditions that might interfere with accurate HRV or pupillometry measurements.
- •Patients with a history of severe allergic reactions to dexmedetomidine or contraindications to its use.
- •Patients currently on medications known to significantly alter autonomic function.
- •Refusal of consent
- •Change in sedation protocol from dexmedetomidine.
结局指标
主要结局
1. To evaluate the changes in HRV as a response to dexmedetomidine administration in NORA settings
时间窗: baseline, start of sedation, end of sedation
次要结局
- 2. To correlate HRV changes with clinically assessed sedation levels using the Richmond Agitation-Sedation Scale (RAAS).(baseline, start of sedation, end of sedation)
研究者
Shweta Suresh Naik
National Institute of Mental Health and Neurosciences
