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临床试验/CTRI/2025/06/089550
CTRI/2025/06/089550尚未招募不适用

Exploring Heart Rate Variability and Pupillometry as Predictors of Sedation Depthin Dexmedetomidine Sedation in Non-Operating Room Anaesthesia (NORA) Settings

Shweta Suresh Naik1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月10日最近更新:

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

发起方
Shweta Suresh Naik
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Shweta Suresh Naik

National Institute of Mental Health and Neurosciences

研究点 (1)

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