The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.
详细描述
Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •II or III The American Society of Anesthesiologists (ASA) physical status
- •age > 18 years
- •bariatric surgery with general remifentanil anesthesia
排除标准
- •anamnesis of using opioids for the treatment of chronic pain
- •opioid dependence
- •younger than 18 years
研究组 & 干预措施
Treatment1
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
干预措施: Ketamine (Drug)
Treatment2
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
干预措施: Ketamine (Drug)
Treatment3
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
干预措施: Ketamine (Drug)
Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
干预措施: Saline (Drug)
Treatment4
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
干预措施: Ketamine (Drug)
结局指标
主要结局
Postoperative pain intensity
时间窗: On the first postoperative day
Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours. Postoperative pain was treated with boluses of i.v. morphine (3 mg) at 3 min. intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10). After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.
Postoperative morphine requirements
时间窗: On the first postoperative day
Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
次要结局
- Incidence of side effects(On the first postoperative day)
- Patients' satisfaction with postoperative analgesia(On the second postoperative day)
研究者
Greta Kasputytė
MD
Lithuanian University of Health Sciences