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临床试验/CTRI/2025/10/095744
CTRI/2025/10/095744尚未招募Phase 3 4

Comparison of Effects of Intravenous Dexmedetomidine and 2 percentage Lignocaine in Perioperative Hemodynamic stability and Post Operative Recovery profile in Laparoscopic Surgery

SRM Medical College Hospital and Research centre kattankulathurchengalpattu district1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation

研究概览

简要总结

Aim is to compare the effects of  intravenous lignocaine and dexmedetomidine on  perioperative hemodynamic parameters in patients undergoing laparoscopic surgeries

Primary objective is to analyse the effects of perioperative hemodynamic stability.Secondary objective is to analyse the  intubation response,time to extubate,postoperative pain relief and pain at discharge from recovery in patients undergoing laparoscopic surgeries.A prospective,interventional,single centric, double blinded, randomized control trial.clinical study will be conducted after getting approval from the Institutional Ethical Committee.Patients were familiarized with the 10-point Visual Analog Scale VAS during the preanesthetic visit. In the operating room, standard multiparameter monitors were connected.Patients in Group D receive dexmedetomidine 0.5microgram per kilogram loading dose over 10 minutes, followed by 0.5 microgram per kilogram per hour infusion, while Group-L receive lidocaine hydrochloride 1.5 mg per kg slow bolus, followed by 1.5 milligram per kilogram per hour infusion,while Group-P 0.9 percentage Normal saline. Anesthetic induction was achieved with fentanyl 2.5  microgram per kilogram  and propofol 2 milligram per kilogram until loss of verbal command. Endotracheal intubation was performed with Atracurium 0.5mg per kilogram.  Anesthesia was maintained with an oxygen/air/sevoflurane mixture 1 MAC and atracurium. After induction continuous hemodynamic parameters is monitored in regular predefined time scale through out the procedure.Intraabdominal pressures,end tidal Co2 and MAC is monitored through out the procedure.After the specific specimen is out, then sevoflurane and study drug infusion will be stopped and extubation will stared after 20-30  minutes from the time of specimen out.Residual neuromuscular blockade was reversed with neostigmine 0.05 milligram per kilogram and glycopyrrolate 0.005 milligram per kilogram. Immediately after extubation, RASS and VAS score is assessedand 20 minutes after extubation repeat VAS will be  monitored.Patients were transferred to the post anesthesia care unit PACU after successful tracheal extubation. Heart rate HR and mean arterial pressure MAP were monitored at regular intervals. Hypotension 20 percentage MAP fall below baseline) was managed with crystalloid boluses and Phenylepherine 10-50 microgram. Bradycardia HR < 45 beats/min was managed with IV atropine 0.6 milligram.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • II class patients. Patients undergoing elective laparoscopic surgery. surgical procedure duration less than 02 hours.

排除标准

  • patients refusal to be part of research.
  • Heart rate less than 60/min and MAP less than 65mmHg History of hypersensitivity to the study drug.
  • chronic use of opioids/opioid addiction, steroids and inability to comprehend postoperatively the pain assessment scale.
  • Neuropsychiatric disorders.

结局指标

主要结局

Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation

时间窗: Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation

次要结局

  • Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability & post operative pain relief without excess sedation(from the time of premedication every three minutes for first)

研究者

发起方
SRM Medical College Hospital and Research centre kattankulathurchengalpattu district
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

professor pushparani

Professor

研究点 (1)

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