跳至主要内容
临床试验/CTRI/2024/10/075661
CTRI/2024/10/075661尚未招募4 期

Effect of Magnesium sulfate and Dexmedetomidine on hemodynamic perturbations,anesthetic requirements and recovery profile in adult patients undergoing Laparoscopic cholecystectomy-A prospective double blind randomized study

Dr S R A N Bhushanam Padala1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年10月28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
84
试验地点
1
主要终点
To compare the effect of Magnesium sulfate and Dexmedetomidine on hemodynamic perturbations following pneumoperitoneum during laparoscopic cholecystectomy

研究概览

简要总结

Laparoscopic surgery is one of the most essential diagnostic and therapeutic techniques in today’s surgical world.It has become the gold standard surgery for cholelithiasis. Philippe Mouret performed the first successful cholecystectomy in 1987. Laparoscopic cholecystectomy has numerous advantages over conventional cholecystectomy.This includes decreased tissue trauma, shorter hospital stay, earlier ambulation, a smaller scar, and less compromised postoperative respiratory and GI systems.However, there are significant hazards linked with it also. In laparoscopic cholecystectomy procedures, CO2 is used to produce pneumoperitoneum mostly.There is a risk of significant hemodynamic changes during laparoscopic cholecystectomy due to laryngoscopy, endotracheal intubation, the creation of pneumoperitoneum, systemic absorption of co2, and the steep head-up (reverse Trendelenburg) position, which is characterized by an abrupt increase in arterial pressure, systemic vascular resistance, and decreased cardiac output.This will create a difficult circumstance for a practicing anesthesiologist. Adequate regulation of the sympathetic response is required to reduce perioperative morbidity and improve patient outcomes.The goal of anesthetic management in laparoscopic procedures is to reduce pneumperitoneum-induced hemodynamic responses while also providing acceptable depth and pain control, with the ultimate goal of minimizing stress response and allowing for early discharge. For these reasons, general anesthesia with tracheal intubation is the preferred anesthetic approach. Like laryngoscopy, the pneumoperitoneum response is mediated by sympathetic overactivity.Many medications, including opioids, vasodilators, beta blockers, nitroglycerin, and midazolam, have been tested throughout the years to suppress the sympathetic response specific to laparoscopic procedures.They all have different levels of advantages and downsides.Previous randomised control trials using dexmedetomidine and magnesium sulfate have yielded excellent results at varying doses. Dexmedetomidine, the active dextro isomer of medetomidine, is a highly selective alpha 2 adrenoreceptor agonist when compared to the alpha 1 receptor (1620:1).This may result in higher  sedative effects while avoiding the negative cardiovascular effects associated with alpha 1 receptor stimulation.It possesses effective analgesic, sedative, hypnotic, anxiolytic, and sympatholytic properties without causing severe respiratory depression. It is used for icu sedation, procedural sedation (awake fibreoptic intubation, colonoscopy, bronchoscopy, and so on), premedication, as a supplement to general anesthesia, intrathecally, and regionally.It can also be utilized to keep hemodynamics stable during a laparoscopic cholecystectomy.The stimulation of alpha2 receptors in the locus ceruleus of the pons lowers central sympathetic output while increasing inhibitory neuronal activity.It accomplishes this by blocking the release of catecholamines.Dexmedetomidine is administered intravenously and produces effects in <5 minutes, peak in 15 minutes. The duration is around 60-120 minutes. Magnesium is essential for a variety of physiological functions.Among the various actions of magnesium, blocking the N-methyl-D-aspartate (NMDA) receptor and calcium channel plays a significant role in anesthesia.The normal range for magnesium in plasma is 0.7-1.1 mmol/L (1.4-2.2 mEq/L). Magnesium sulphate delivered IV would also be effective in reducing unfavorable hemodynamic reactions since magnesium has the potential to block catecholamine production from both the adrenal gland and the adrenergic nerve terminal.It also acts on blood vessels in order to dilate them and reduce vasopressin-mediated constriction, and has direct myocardial depressant actions . The present study was undertaken with the objective of comparing the effectiveness of dexmedetomidine (10mcg/ml ,0.1ml/kg for 15 min followed by 0.03ml/kg/hr infusion)on hemodynamic perturbations ,anesthetic requirements and recovery profile in adult patients undergoing laparoscopic cholecystectomy with that of magnesium sulfate(300mg/ml,0.1ml/kg for 15 min followed by 0.03ml/kg/hr infusion). Many studies have been conducted with varying doses of dexmedetomidine to find it’s effectiveness in reducing hemodynamic stress responses in laparoscopic cholecystectomy as well as other surgeries. But magnesium sulfate is a less explored drug in this regard.To the best of our knowledge there are not any published article comparing dexmedetomidine and magnesium sulfate infusions for reducing hemodynamic prturbations in laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • 1.Age:18-65 years 2.ASA Physical status 1 and 2.

排除标准

  • 1.Patients with hypermagnesemia 2.Patients with heart blocks or arrythmias 3.Patients allergic to study drugs and addicted to narcotics 4.Patients with chronic liver/renal/cardiovascular diseases 5.Patients who are on beta blockers 6.Surgeries which lasts for more than 4 hours.

结局指标

主要结局

To compare the effect of Magnesium sulfate and Dexmedetomidine on hemodynamic perturbations following pneumoperitoneum during laparoscopic cholecystectomy

时间窗: T4-Before pneumoperitoneum | T5-1 min after pneumoperitoneum | T6-5 min after pneumoperitoneum | T7-15 min after pneumoperitoneum | T8-30 min after pneumoperitoneum | T9-After release of pneumperitoneum

次要结局

  • To compare the effect of magnesium sulfate and dexmedetomidine on hemodynamic perturbations following laryngoscopy and intubation(T0-Base line)
  • To compare the effect of study drugs on intraoperative anesthetic requirement(propofol and fentanyl)(Throughout intraoperative period)
  • To compare the effect of study drugs on postoperative recovery profile (extubation,eye opening and recovery times and NRS(T10-1 min after extubation)

研究者

发起方
Dr S R A N Bhushanam Padala
申办方类型
Other [Guide(Assistant Professor)]
责任方
Principal Investigator
主要研究者

Dr Neha Basheer P

All India Institute Of Medical Sciences,Bhopal

研究点 (1)

Loading locations...

相似试验

Dexmedetomidine vs Magnesium sulfate in blood... | 临床试验