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临床试验/CTRI/2026/01/100844
CTRI/2026/01/100844尚未招募不适用

Outcomes (morbidities and mortality) after long bone lower limb surgeries: A prospective comparison of spinal versus general anaesthesia

M D M Hospital Dr S N Medical College Jodhpur1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年1月30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
1,200
试验地点
1

研究概览

简要总结

This prospective observational comparative study will be conducted to evaluate differences in postoperative morbidity and mortality between patients receiving spinal anaesthesia and those receiving general anaesthesia for long bone lower limb surgeries.

To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation on the basis of a detailed history from the patient and thorough physical examination as well as pre-anaesthetic airway assessment (mouth opening, thyromental distance, Mallampati grade, dentition, etc) will be done. Basic demographic data like name, age, sex, height, and body weight for BMI will be recorded. Complete general physical examination, BMI check, investigations and ASA grading will be done. In all the patients, baseline investigations will be done to rule out any abnormalities. The purpose and detailed procedure and visual analogue scale (VAS) will be explained to the patients. Written informed consent will be taken from all the patients about the procedure. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery.  After a complete pre-anaesthetic evaluation, patients will be taken into the operation theatre and standard ASA monitoring parameters like SPO2, blood pressure, ECG, EtCO2, etc. will be attached. After the decision for the type of anaesthesia (according to the patient’s consent and associated co-morbidities of patients) will be taken by the anaesthesiologist involved in the patient’s management during surgery. The anaesthesia (spinal anaesthesia or general anaesthesia) will be given to patients according to the needs of the patient and as per institutional guidelines. All the patients will be monitored during the perioperative period as per protocol and will be followed up for 30 days after the surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I to IV Patients undergoing elective and emergency long-bone lower limb surgeries either spinal anaesthesia or general anaesthesia.

排除标准

  • Patients who refuse to participate Patients with known allergy to anaesthetic drugs Pre existing neurological deficits Patients with any history of acute illness.

研究者

发起方
M D M Hospital Dr S N Medical College Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Geeta Singariya

Dr SN Medical Collage Jodhpur

研究点 (1)

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