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临床试验/CTRI/2026/04/107263
CTRI/2026/04/107263尚未招募不适用

Correlation of non-invasive carotid doppler indices with pulse pressure variability based goal-directed hemodynamic therapy in prone-position thoracolumbar and lumbar neurosurgical procedures: a prospective observational study

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年5月1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
62
试验地点
1

研究概览

简要总结

This prospective observational study will be conducted in the Departments of Anaesthesiology and Intensive Care in collaboration with Department of Neurosurgery after Institutional Ethics Committee approval. Adult patients undergoing thoracolumbar and lumbar neurosurgical procedures in the prone position will be enrolled following written informed consent. All participants will undergo standard pre-anaesthetic evaluation including detailed history, clinical examination, and review of laboratory and imaging investigations. Routine medications will be continued until the morning of surgery and standard fasting guidelines followed.

In the operating room, standard ASA monitors along with BIS, ABG, TOF, and invasive arterial blood pressure monitoring will be instituted. Anaesthesia will be induced with propofol using target-controlled infusion (Eleveld model), fentanyl, and rocuronium, followed by tracheal intubation. Maintenance will include propofol TCI titrated to maintain BIS 40–60, fentanyl infusion, and rocuronium with volume-controlled ventilation adjusted to maintain normocapnia.

Baseline haemodynamic and Carotid Doppler parameters will be recorded after induction. Fluid preloading with 6 ml/kg hydroxyethyl starch will be administered, followed by reassessment. Patients will then be positioned prone using the dual transverse roll technique, and Carotid Doppler parameters reassessed after stabilization. Carotid Doppler parameters and pulse pressure variation will be recorded hourly until surgery completion. At the end of surgery, patient will be made supine and final measurements will be taken. Neuromuscular blockade will be reversed; trachea will be extubated once patient meets the extubation criteria, and patient will be shifted to Intensive Care Unit (ICU) for further management.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All ASA (American Society of Anaesthesiology) physical status I & II patients, scheduled for elective thoracolumbar and lumbar spine surgery in the prone position.

排除标准

  • •Impaired left ventricular function (ejection fraction less than 50%).
  • •Moderate to severe valvular disease.
  • •ECG Rhythm disturbance.
  • •Carotid artery disease or stenosis more than 50%.
  • •Basal Metabolic Index (BMI) more than 30 or less than 15 kg m2 •History of cerebrovascular accident or transient ischemic attack.
  • •Respiratory system disease affecting lung compliance •Inability to obtain adequate Carotid Doppler signals.
  • •Severe peripheral arterial occlusive disease.

研究者

发起方
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SUNIL JOE JACOB

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

研究点 (1)

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