临床试验/CTRI/2024/10/074615

CTRI/2024/10/074615尚未招募2/3 期

Comparison of Quality of Recovery between General Anaesthesia and Thoracic Spinal Anaesthesia in patients undergoing laparoscopic abdominal surgery: A single blinded randomised controlled trial

未提供1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2024年11月20日最近更新: 2024年9月22日

试验速览

阶段: 2/3 期
状态: 尚未招募
入组人数: 72
试验地点: 1
主要终点: Quality of Recovery following surgery

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is a randomised single blinded prospective parallel arm active controlled trial to compare Quality of Recovery at 24 hours following surgery as primary outcome with any new onset in house morbidity, mortality, patient’s and surgeon’s satisfaction analyses, percentage conversion to general anaesthesia and ICU stay as secondary outcomes between General Anaesthesia and Thoracic Spinal Anaesthesia group of patients undergoing laparoscopic/robotic elective abdominal surgeries in AIIMS, Rishikesh in approximately next 18 months from the expected date of first allotment

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Outcome Assessor Blinded

入排标准

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

入选标准

•American Society of Anaesthesiologists (ASA) grade I-III patients undergoing elective laparoscopic/robotic abdominal surgeries.

排除标准

•Patients with informed refusal Patients undergoing emergency and open abdominal surgeries Patients with severe medical illnesses (ASA IV-V grade) Patients with known allergy to anaesthestic drugs Patients having absolute/relative contraindications to spinal anaesthesia Pregnant patients.

结局指标

主要结局

Quality of Recovery following surgery

时间窗: At 24 hours after surgery

次要结局

Compare the Post Anaesthesia Cre Unit (PACU) stay by using modified Aldrete score(At every 15 minutes intervals after surgery gets over till patients get discharged from PACU)
Compare the Length of Stay (LoS) in the hospital(From the date of Admission (DoA) to Date of Discharge (DoD))
To look for any in house new onset morbidity(Upto 3 months following surgery)
To compare how satisfied surgeons are(Baseline at the end of surgery)
To compare how satisfied patients are(24 hours of postsurgical timeline)
To note the percentage conversion to General Anaesthesia(Baseline at the end of surgery)
Assessment of in house mortality following surgery(At 30 and 90 days after surgery)

研究者

发起方

未提供

责任方

Principal Investigator

主要研究者

Dr Abhisek Dey

All India Institute of Medical Sciences (AIIMS), Rishikesh

研究点 (1)

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