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临床试验/CTRI/2025/11/096906
CTRI/2025/11/096906尚未招募不适用

Effect Of Different Anaesthetic Techniques On Neutrophil To Lymphocyte Ratio And Systemic Immune Inflammation Index In Patients Undergoing Laparoscopic Tubal Ligation - A Randomised Prospective Observational Study.

ESIC Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1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
100
试验地点
1
主要终点
To calculate the neutrophil lymphocyte ratio from blood counts on the day of surgery and compare the value with the neutrophil lymphocyte ratio obtained on post operative day 1 ie; 24 hours later.

研究概览

简要总结

Following approval from ethical committee and written informed consent from the patients. The study subjects would be divided into two groups. Group G would receive general anaesthesia and group S would receive spinal anaesthesia. The patients would be randomly allocated to one of the two groups. All patients will be assessed preoperatively and informed both techniques of anaesthesia and their risks and benefits. The patients would be fasted according to current anaesthetic guidelines. Preoperative haemoglobin levels, total leukocyte counts, differential count, NLR and systemic immune inflammation index would be evaluated along with the other necessary routine investigations. On the day of surgery, IV access will be established and balanced salt solution will be commenced. All patients will be monitored using NIBP, SPo2 and ETCO2. Baseline hemodynamic parameters will be recorded. Patients allocated to group G would be induced with propofol 2mg/kg and muscle relaxation achieved with vecuronium 0.1mg/kg IV. Following ventilation with oxygen, air and sevoflurane for 3 minutes, the trachea would be intubated with size 7mm tracheal tube and anaesthesia would be maintained with oxygen and air mixture 1-2% sevoflurane titrated to maintained the hemodynamic parameters within 15-20% of basal readings. Additional muscle relaxation for top up would be administered using vecuronium 0.05mg/kg as needed. Following completion of surgery, patients would be extubated after antagonism of residual neuromuscular blockade using glycopyrrolate 0.01mg/kg and neostigmine 0.05 mg/kg. Patient allocated to the spinal anaesthesia group would receive 0.5% heavy bupivacaine at T10 interspace in the sitting position using a volume of 1.8 ml. ECG, NIBP and SPO2 would be monitored continuously throughout the procedure. Any decrease in blood pressure would be corrected immediately by the administration of phenylephrine 50 micrograms boluses to maintain the arterial blood pressure within 20% of a baseline values.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Women undergoing elective tubal ligation under general Anastasia Or spinal anaesthesia.
  • Belonging to ASA physical status 1 or
  • Aged between 18-35 years.

排除标准

  • Refusal to participate 2) Active infections or recent illness 3) Immunocompromised state 4) Chronic inflammatory conditions like SLE or RA 5) Morbid obesity.

结局指标

主要结局

To calculate the neutrophil lymphocyte ratio from blood counts on the day of surgery and compare the value with the neutrophil lymphocyte ratio obtained on post operative day 1 ie; 24 hours later.

时间窗: T1: just before surgey starts. | T2-24hrs after surgery.

次要结局

  • To calculate the systemic immune inflammatory index from the routine blood counts on the day of surgery and to compare it with the value obtained 24 hours later.(1st: just before surgey starts.)

研究者

发起方
ESIC Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bhukya Ajay

ESIC Medical College and Hospital

研究点 (1)

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