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临床试验/CTRI/2024/04/066031
CTRI/2024/04/066031尚未招募3 期

The effect of preoperative carbohydrate loading and perioperative opioid sparing multimodal analgesia on patient outcomes in Enhanced Recovery After Cardiac Surgery (ERACS) - A randomized controlled trial

Sree Chitra Tirunal Institute of Medical Science and Technology1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1) The primary objective is the assessment of perioperative blood glucose level and insulin requirements in patients receiving oral clear carbohydrate containing fluid before surgery.

研究概览

简要总结

ERAS (Enhanced Recovery After Surgery) is a multidisciplinary initiative to improve perioperative care, early discharge and reduce the cost of patients.1 ERAS protocol has already been well established in other surgeries like colorectal, gynecological surgeries and has been widely followed worldwide. There are several important components of ERAS include preop patient education, clear carbohydrate fluid intake in the morning and reduce fasting time, opioid sparing multimodal analgesia, post operative nausea prevention, early extubation and early mobilization. Among these components we have taken two most important components like clear carbohydrate fluid intake in the morning and reduce fasting time and opioid sparing multimodal analgesia, and planning to assess its effect on overall patient postoperative outcome. The studies have shown that preoperative oral carbohydrate intake reduces postoperative insulin resistance and improves glucose metabolism.2 It also helps in early return of gut function3, modifies hormonal and metabolic response, reduces surgical site infections and length of hospital stay. Preoperative oral carbohydrate intake 2 hours before general anesthesia is recommended as a part of Enhanced Recovery After Surgery (ERAS) pathway. But however it is not completely implemented in cardiac surgery due to varying level of evidences.4  ERAS protocol recommends to reduce the opioid usage and follow multimodal analgesia strategy.5 Transverse thoracic muscle plane (TTP) block is a new perioperative analgesic method for post sternotomy discomfort. For patients undergoing heart surgery, TTP block offers sufficient postoperative pain control, resulting in lower pain scores, lower postoperative analgesic doses, shorter  extubation times, and shorter ICU stay lengths.6 TTP block reduces the perioperative  opioid consumption and  the incidence of nausea and vomiting.7,8 Lidocaine is a widely available and commonly used local anaesthetic. When administered intravenously it demonstrates anti hyperalgesic properties that improve acute postoperative pain management. Lignocaine also decreases the MAC (Minimal Alveolar Concentration) of volatile agents, reduces analgesic consumption and better analgesia.9 Lignocaine infusion for pain has been widely accepted and implemented in colorectal  ERAS protocol.10 Now it needs to be implemented in cardiac surgery for better analgesia. Similarly Dexmeditomedine  infusion provides better analgesia and reduces opioid  usage in the perioperative period.11 So, preoperative carbohydrate loading with opioid sparing multimodal analgesia improves outcome in patients undergoing cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients greater than 18 years of age undergoing elective cardiac surgeries either CABG (On pump and off pump) or valve surgeries.

排除标准

  • 未提供

结局指标

主要结局

1) The primary objective is the assessment of perioperative blood glucose level and insulin requirements in patients receiving oral clear carbohydrate containing fluid before surgery.

时间窗: During the intraoperative period and 48 hours post surgery in the Intensive care Unit

次要结局

  • 2) The secondary objectives are the inotropic and vasopressor requirements, post op ventilation time, length of ICU stay, duration of mechanical ventilation post operative arrhythmias, post operative pain score, pneumonia and surgical site infection.(48 hours perioperative period)

研究者

发起方
Sree Chitra Tirunal Institute of Medical Science and Technology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrSathesh Kumar

cardiac anesthesia department Sree Chitra Tirunal Institute of Medical Science and Technology

研究点 (1)

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