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临床试验/CTRI/2025/04/083772
CTRI/2025/04/083772尚未招募4 期

Comparison of Intravenous Dexmedetomidine and Lidocaine infusion for Perioperative Analgesic Consumption in Patient’s Undergoing Laparoscopic Gynaecological Surgeries: A Randomized Study

Dr Pranita Mandal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1.To compare the duration of post operative analgesia(defined as the time to first request for rescue analgesia following extubation, when VAS is more than four between the group receiving Dexmedetomidine 1 mcg/kg over 10 min before anesthesia induction followed by infusion at 0.3 mcg/kg/min after anesthesia induction and the group receiving 2% Lidocaine hydrochloride 1.5 mg/kg over 10 min before anesthesia induction followed by infusion at 1.5mg/kg/h after anesthesia induction

研究概览

简要总结

All patients will be familiarised about 10-point Visual Analog Scale (VAS) during the preanesthetic visit.On the day of surgery, all ASA standard monitoring will be applied, and two 18 G intravenous cannula will be secured.Baseline parameters will be noted heart rate, Systolic blood pressure, Diastolic blood pressure,Mean arterial pressure SpO2, Bispectral index etc. Balanced salt solution will be connected inone of the 18 G intravenous cannula.All patients will be premedicated with intravenous glycopyrrolate 4 mcg/Kg. Study drug bolus infusion over 10 min will be started as per group allocation (Group D or Group L). After this initial bolus infusion, general anesthesia will then be instituted with Inj.Ketamine 0.5mg/Kg, Inj.Propool 1.5-2 mg/Kg till the loss of verbal command is commenced, Inj.Rouronium 0.6 mg/Kg intravenous and endotracheal intubation will be performed after 3 min.Afterwards maintenance dose of the study drug and Inj.Ketamine infusion of 0.25 mg/Kg/hr will be started. General anesthesia will be maintained with oxygen/air/sevoflurane mixture, intermittent boluses of Inj.Rocuronium to maintain Bispectral index of 40-60.Pre-emptive intravenous Diclofenac 75 mg, Inj.Dexamethasone 0.1mg/Kg will be administered post intubation. Hemodynamic parameters,BIS, will be recorded at baseline, before the start of study infusion drugs,10 min after starting the infusion of study drug, immediately after induction, during laryngoscopy and tracheal intubation, immediately prior and after pneumoperitonium creation, and then every 15 min,till the end of surgery.As per the standard protocol Intra operative management include treating hypotension and bradycardia with appropriate and total intra operative fentanyl requirements will be noted.Infusions of the study drug and ketamine will be discontinued upon release of pneumoperitonium and trocar removal and Inj.Ondanstron 4 mg, Inj.Paracetamol 1 gm will be given and continued every 8th hourly afterwards.Residual neuromuscular blockade will be reversed following completion of surgery.After successful tracheal extubation , patients will be transferred to PACU for further monitoring. The time from skin incision to completion of skin closure will be noted and the duration of surgery will be calculated in minutes. The total duration of anesthesia from the time of commencement of infusion of study drugs till tracheal extubation will also be calculated in minutes.Time from stoppage of infusions and tracheal extubation will be noted in minutes.

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
Female

入选标准

  • ASA class I and II , scheduled For Elective Laparoscopic Gynecological surgeries like Hysterectomy, Adnexectomy, Myoma enucleation, Diagnostic laparoscopy etc.

排除标准

  • Non consenting patient, Malignant surgeries, BMI More Than 30 Kilogram Per Metre Square, Pregnant and Breastfeeding patients, history of chronic pain on analgesics and sedatives, significant or major comorbidities such as congestive heart failure, myocardial infarction in the past 6 months, heart block, fixed cardiac output lesions, chronic liver or kidney illnesses, and chronic use of opioids or opioid addiction, steroids, allergy to any medication, previous treatment with anti-platelet agents, antihypertensive medication with clonidine or other beta 2 adrenergic agonist, and inability to comprehend postoperatively the pain assessment scale and sedation scale.

结局指标

主要结局

1.To compare the duration of post operative analgesia(defined as the time to first request for rescue analgesia following extubation, when VAS is more than four between the group receiving Dexmedetomidine 1 mcg/kg over 10 min before anesthesia induction followed by infusion at 0.3 mcg/kg/min after anesthesia induction and the group receiving 2% Lidocaine hydrochloride 1.5 mg/kg over 10 min before anesthesia induction followed by infusion at 1.5mg/kg/h after anesthesia induction

时间窗: At Extubation | 15 min | 30 min | 1 hr | 2 hr | 3 hr | 4 hr | 8 hr | 12hr | 24h

2.To evaluate the cumulative postoperative rescue analgesic consumption within the first 24 hours, after extubation.

时间窗: At Extubation | 15 min | 30 min | 1 hr | 2 hr | 3 hr | 4 hr | 8 hr | 12hr | 24h

次要结局

  • 1.Total intraoperative Inj. Fentanyl consumption in both the groups.(2.VAS scores measured at predefined intervals)

研究者

发起方
Dr Pranita Mandal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Fathima beevi

All India Institute Of Medical Sciences, Bhopal

研究点 (1)

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