Comparative evaluation of paracetamol and dexmedetomidine on peri-operative haemodynamics and post-operative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To study the effectiveness of paracetamol & dexmedetomidine on peri-operative
研究概览
简要总结
Laparoscopic cholecystectomy is gold standard surgical treatment for cholelithiasis
and cholecystitis. It is a minimally invasive procedure in which inert gas is insufflated into
the abdomen, creating pneumoperitoneum. Due to the combined effect of anaesthetic agents,
positioning of patient, absorption of gas and pneumoperitoneum, there is occurrence of
marked hemodynamic changes. Peri-operative hemodynamics monitoring plays a critical
role for improving post-operative outcomes. In an anaesthetized patient, it provides crucial
information regarding cardiac output, volume status, tissue perfusion, and depth of anaesthesia
and adequate pain control. After CO2 insufflation, if the intraabdominal pressure is more than 10
mmHg, then there is significant alteration of haemodynamics due to vena cava compression
and pooling of blood in lower extremities, causing decrease in venous return and cardiac
output. The increase in peripheral vascular resistance is contributed by increase in intra
thoracic pressure due to increased intra-abdominal pressure and also by the release of
catecholamines and vasopressin due to mechanical stimulation of peritoneal receptors.
Sudden stretching of peritoneum during laparoscopy may lead to arrhythmias (bradycardia).
and asystole).
Post-operative pain management and monitoring of pain relief have become important
post-operative quality measure. The desired goal is to alleviate or eliminate pain and its
discomfort in patients with the fewest side effects.3 Adequate pain relief is crucial to treating
patients undergoing surgery. There have been studies suggesting that, out of the total number of
patients undergoing surgery, more than 80% experience acute post operative pain and out of
these, approximately 75%, report severity of post operative pain as moderate , severe or
extreme. There are also evidences to suggest that less than 50% of patients reports adequate
pain relief after surgery.4 For the management of post operative pain, various
pharmacological agents have been tried (opioid vs non-opioid) via different routes ( oral,
intravenous, neuraxial, and regional).
Dexmedetomidine is a highly selective alpha-2 receptor agonist. It is having
sympatholytic, sedative, analgesic, and opioid-sparing properties and does not cause respiratory
depression. It also decreases the incidence of postoperative nausea and vomiting. Intravenous
dexmedetomidine also has efficacy in improving perioperative hemodynamic stability and
post-operative analgesia. In addition, it also decreases the intraoperative consumption of
anaesthetics and opioids, It also has direct antiemetic effect by activating alpha-2
receptors. Minor side effects like hypotension and bradycardia can occur with
dexmedetomidine .
Paracetamol is widely used as an antipyretic and analgesic and its presumed mechanism of
action being inhibition of central cycloxygenase (COX 3), which causes decreased production
of prostaglandins in the CNS. It might also act through opioidergic system and NMDA receptors
and by regulation of inhibitory serotonergic pathways.
Since perioperative hemodynamics and post operative pain are the major
concerns in patients undergoing laparoscopic cholecystectomy under general anaesthesia, we
decided to perform a study to compare the effect of Paracetamol and
dexmedetomidine on perioperative hemodynamics and postoperative analgesia.
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
- •The study will include 90 patients of either sex.
- •age 18–60 years, belonging to American Society of Anesthesiologists (ASA) physical status of I-II with scheduled for elective laparoscopic cholecystectomy under general anaesthesia and will be assigned to two groups.
排除标准
- •Obesity Already receiving beta blocker or alpha-2 agonists History of allergy to test drug History of hypertension with or without medication History of cardiopulmonary disease History of hepatic and renal dysfunction History of psychological disorders History of alcohol and drug abuse Receiving opioid analgesics during last 24 hours before surgery Heart Rate less than 50bpm Refusal to participate in the study.
结局指标
主要结局
To study the effectiveness of paracetamol & dexmedetomidine on peri-operative
时间窗: First of all, spo2, NIBP, and pulse rate will be recorded at baseline before and after the administration of drugs and pain score will be assessed at 1/2, 2, 4, and 6 hours in patients undergoing laparoscopic cholecystectomy under general anaesthesia .
hemodynamics and postoperative analgesia in patients undergoing laparoscopic
时间窗: First of all, spo2, NIBP, and pulse rate will be recorded at baseline before and after the administration of drugs and pain score will be assessed at 1/2, 2, 4, and 6 hours in patients undergoing laparoscopic cholecystectomy under general anaesthesia .
cholecystectomy under general anaesthesia .
时间窗: First of all, spo2, NIBP, and pulse rate will be recorded at baseline before and after the administration of drugs and pain score will be assessed at 1/2, 2, 4, and 6 hours in patients undergoing laparoscopic cholecystectomy under general anaesthesia .
次要结局
- All the vital parameters (spo2, pulse rate, NIBP, & pain score) will be assessed.(At baseline, just before & after the administration of drugs & pain score at 1/2, 2, 4 & 6 hours post-operatively)
研究者
Dr Nandita Kad
Pt B.D. Sharma PGIMS Rohtak
