跳至主要内容
临床试验/CTRI/2024/11/076187
CTRI/2024/11/076187尚未招募Unknown

Effect of surgical plethysmography index on perioperative opioid use in patients undergoing laparoscopic nephrectomy under general anesthesia - A randomized controlled study

Nizams institute of medical sciences1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
76
试验地点
1
主要终点
compare the amount the amount of intraoperative injection fentanyl requirement in SPI- guided group and conventional group which is based on hemodynamic response- based group.

研究概览

简要总结

Though systemic opioids are commonly used and provide good pain relief, there is an increase incidence postoperative nausea and vomiting, urinary retention,respiratory depression and especially in cancer patients several studies have shown that tumor recurrence and decreased disease free and overall survival rate. As it is impossible to completely do away with perioperative opioid use, emphasis has been on opioid sparing analgesia.

To support this a search for newer modality has been increased which easy and inexpensive. Surgical pletysmography is new modality used to monitor nociceptive stimuli and anti-nociceptive drug effect during surgery using the pulse wave photoplethysmographic amplitude and heart rate interval derived from pulse oximetry measurements, represents the mean surgical stress level during anaesthesia.

The present study is planned to evaluate the utility of SPI ( surgical plethysmograhic index ) in providing opioid sparing analgesia.

This study is a randomized double blinded study which will be done in patients scheduled for laparoscopic radical nephrectomy.

Conduct of study as follows, Patients are divided are into 2 groups, that is SPI- guided analgesia group injection fentanyl will be given @IV 0.5mcg/kf bolus when SPI above 50 for more than 5min. other group is that is Control group, injection fentanyl was given at standard practice based on changes in heart rate and blood pressure >20% of the base line.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing elective laparoscopic nephrectomy,with ASA grade 1 and 2, normal renal and liver function test and hemoglobin 9gram/dl.

排除标准

  • patient refusal, emergency surgery, patients who are hemodynamically unstable, pregnant women and who has history of opiod abuse.

结局指标

主要结局

compare the amount the amount of intraoperative injection fentanyl requirement in SPI- guided group and conventional group which is based on hemodynamic response- based group.

时间窗: from time of patient induction to extubation

次要结局

  • check incidence of number of hemodynamic events such as tachycardia, unwanted somatic movements, time for extubation ( time from spontaneous breathing efforts to removal endo tracheal tube)(postoperative tramadol requirement.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sharat krishna reddy kesavareddy

Nizams institute of medical sciences.

研究点 (1)

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