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临床试验/CTRI/2025/07/089936
CTRI/2025/07/089936尚未招募不适用

Comparative analysis of pain on Propofol injection with pretreatment using Cold saline Lignocaine Cold saline plus Lignocaine and Normal saline in patients undergoing general anaesthesia A Prospective Observational Study

Hrithika1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年7月14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
132
试验地点
1
主要终点
Incidence and severity of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline using pain score

研究概览

简要总结

In this study "**COMPARATIVE ANALYSIS OF PAIN ON PROPOFOL INJECTION WITH PRETREATMENT USING COLD SALINE, LIGNOCAINE, COLD SALINE PLUS LIGNOCAINE AND NORMAL SALINE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA: A PROSPECTIVE OBSERVATIONAL STUDY”**This prospective observational study is designed to evaluate pain during propofol injection in patients pretreated with cold saline, lignocaine, cold saline plus lignocaine and normal saline, to compare the efficacy of pre-treatment methods: cold saline, lignocaine and their combination to normal saline in providing pain relief on propofol injection (POPI) during various surgeries under general anaesthesia (G.A)

Attending anaesthesiologist will provide pretreatment and principal investigator will only observe and document the pain score

 The anaesthesia protocol will adhere to standard practices and anaesthesia will be provided by experienced anaesthesiologist. Monitoring will encompass standard parameters. A standard 20-gauge peripheral intravenous (IV) cannula will be placed into largest visible vein, preferably on dorsum of hand as standard practice to administer propofol. This study will include 132 participants of American Society of Anaesthesiologist physical Status (ASA PS) 1 or 2, of all genders in age group of 19-65 years undergoing GA will be enrolled in the study. Attending Anaesthesiologist will provide pretreatment as per patient posted for surgery under general anaesthesia, the patients will be assigned to one of the four pretreatment groups: In Group C-33 patients will receive 10ml cold saline at .Group L -33 patients will receive 3ml of lignocaine. Group CL- 33 patients will receive Cold saline plus lignocaine. In Group N- 33 patients will receive 10 ml of normal saline at room temperature, following pretreatment, patients will be given 5ml of propofol over 5 second. Soon after propofol injection, Principal investigator will ask the patient for any pain and signs of pain observed will be graded on pain score from none to severe. Principal investigator  will  record Heart rate before and after the propofol injection. After the surgery, patients will be shifted to the post-anesthesia care unit (PACU). Post-operative recall of pain on propofol injection will be assessed in the PACU by the principal investigator, once fully conscious, the patient will grade pain using the Numerical Rating Scale (NRS)

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1.The patient who are undergoing general anaesthesia and eligible cases during the study period are covered 2.American Society of Anaesthesiologist physical status (ASA PS) I and II 3.BMI 18-24 Kg/m2.

排除标准

  • 1.Allergy to study medication 2.Serious venous insufficiency 3.Pregnant/lactating women.

结局指标

主要结局

Incidence and severity of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline using pain score

时间窗: pain score is taken Immediately after giving 5ml of propofol injection (within 5 to 10 seconds)

次要结局

  • Post operative recall of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline(post-operatively patient will grade pain using numerical rating scale when fully conscious within 1-2 hours)

研究者

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

Hrithika

Yenepoya School Of Allied Health Sciences

研究点 (1)

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