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临床试验/CTRI/2025/01/079043
CTRI/2025/01/079043尚未招募4 期

PREEMPTIVE ANALGESIA USING LOW DOSE INTRAVENOUS KETAMINE FOR POST OPERATIVE PAIN IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY

Dr Nazia Akhtar Barbhuiya1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2025年1月30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
190
试验地点
1
主要终点
To evaluate the efficacy of preemptive use of small dose intravenous ketamine on post operative pain using Numeric Rating Scale Score on patients undergoing elective laparoscopic cholecystectomy

研究概览

简要总结

The most important factor related to patient discomfort after surgery is pain. The concept of Pre-emptive analgesia is to reduce central sensitization that arises from noxious input during the perioperative period and also the magnitude and duration of post operative pain.

Pre-emptive analgesia gives rise to a subsiding pain pattern, a decrease in analgesic requirement and a decline in morbidity,  promoting wellness and shortening the length of hospital stay.

Laparoscopic cholesystectomy as a minimally invasive surgery has become extremely common in recent decades. Despite the fact that Laparoscopic cholecystectomy is associated with less pain and disability , nonetheless as many as 76.7% patients  experience moderate to severe pain ( NRS 4-10) within first 24 hours

Although many drugs have demonstrated the evidence of preemptive analgesic benefit. Ketamine , an NMDA receptor antagonist have received greatest attention because NMDA receptors have effectiveness to intercept intra as well as post operative pain and also had role in central sensitization and neural modulation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age : 18-60years.
  • 2.ASA grade 1 and
  • 3.Patient posted for elective laparoscopic cholecystectomy.
  • 4.Patients giving consent to participate in the study.

排除标准

  • Patient not willing to give informed and written consent.
  • BMI more than
  • Surgery converted to open cholecystectomy.
  • Chronic pain syndrome.
  • Drugs , opiods , or any substance abuse.
  • History of allergy to ketamine.
  • Raised intra-cranial pressure.
  • Known case of hypertension , hyperthyroidism , psychiatric disorder.
  • History of seizure or taking anticonvulsant medication.

结局指标

主要结局

To evaluate the efficacy of preemptive use of small dose intravenous ketamine on post operative pain using Numeric Rating Scale Score on patients undergoing elective laparoscopic cholecystectomy

时间窗: To evaluate the efficacy of preemptive use of small dose intravenous ketamine on post operative pain using Numeric Rating Scale Score at time 0(immediately after arousal), 6,12 and 24 hours on patients undergoing elective laparoscopic cholecystectomy

次要结局

  • 1. To evaluate time interval for first request of analgesia.(2.To evaluate post operative total opioid consumption in first 24 hours.)

研究者

发起方
Dr Nazia Akhtar Barbhuiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nazia Akhtar Barbhuiya

Gauhati Medical College And Hospital , Guwahati

研究点 (1)

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