Influence of Dexmedetomidine and Lidocaine on Opioid Consumption, Cognitive Function and Incidence of Neuropathic Pain in Laparoscopic Intestine Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Consumption of Fentanyl
研究概览
简要总结
Using combination of opioid analgesics and analgesics with different mechanism of action the investigators can decrease the consumption of opioid analgesics and their side effects. The investigators will use opioid analgesic fentanyl alone or in combination with dexmedetomidine or lidocaine.The participants scheduled for laparoscopic intestine resection will be divided in three groups: in the first group, the participants will receive single boluses of fentanyl, in the second group, the participants will receive continuous infusion of lidocaine and single boluses of fentanyl, and in the third group, the participants will receive continuous infusion of dexmedetomidine and single boluses of fentanyl. Participants with intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of fentanyl during the operation and less opioid analgesics after the operation in comparison to those who will receive only fentanyl boluses. Better cognitive function after the operation is expected in participants receiving dexmedetomidine infusion. There will be minimal incidence of neuropathic pain because of minimal surgical injury of peripheral nerves in all groups of patients.
详细描述
Introduction: The consumption of opioid analgetics and their side effects can be minimized by using the combination of opioid analgesics and analgesics with different mechanism of action. The investigators will use opioid analgesic fentanyl alone or in combination with dexmedetomidine or lidocaine. Dexmedetomidine is alpha 2 adrenergic receptor agonist and is used more and more during anesthesia because of its anesthetic and analgesic effects as it preserves mental status and decreases the consumption of analgesics. Lidocaine is a local anesthetic and antiarrhythmic drug which decreases opioid consumption as well.
The participants scheduled for laparoscopic intestine resection will be divided in three groups: in the first group, the participants will receive single boluses of fentanyl, in the second group, the participants will receive continuous infusion of lidocaine and single boluses of fentanyl, and in the third group, the participants will receive continuous infusion of dexmedetomidine and single boluses of fentanyl.
Hypothesis: Participants with intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of fentanyl during the operation and less opioid analgesics after the operation in comparison to those who will receive only fentanyl boluses. Better cognitive function after the operation in participants receiving dexmedetomidine infusion is expected. There will be minimal incidence of neuropathic pain because of minimal surgical injury of peripheral nerves in all groups.
Justification: Lidocaine and dexmedetomidine are analgesics with different mechanism of action in comparison to opioid analgesics. Their use during the operation decreases the consumption of opioids intra- and postoperatively. Dexmedetomidine has beneficial effect on cognitive function and that is why the investigators expect preserved cognitive function in participants after the operation. Because of minimal surgical injury and, therefore, minimal probability of peripheral nerve injury, the investigators expect low incidence of neuropathic pain in all groups.
Methods: The investigators will include 60 participants in the study, between 35 to 85 years old, ASA 2 - 3 (American Society of Anesthesiologists, ASA) undergoing a planned laparoscopic intestine resection. The participants will be randomized into three groups. In the first group, fentanyl boluses will be adimistred during the operation, in the second, infusion of lidocaine will be added to fentanyl, and in the third, the infusion of dexmedetomidine will be added to fentanyl. The investigators will record opioid consumption during the operation and two days after the operation. The investigators will use mini mental test for evaluation of cognitive function before the operation and at the transfer of the participant postoperatively to the surgical ward, in order to explore the influence of analgesics used on cognitive function. Two months after the operation the degree of neuropathic pain will be evaluated with pain questionnaire. The data will be statistically evaluated.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 35 to 85,
- •ASA 2-3 (according to the classification of American Society of Anesthesiologists),
- •undergoing a planned laparoscopic intestine resection at the Department of Abdominal Surgery at the University Medical Centre Ljubljana.
排除标准
- •allergies to alpha 2 receptor agonists,
- •uncontrolled arterial hypertension,
- •2nd and 3rd degree atrioventricular block,
- •alcohol and illegal drugs abusers,
- •patients with clinically important neurological, cardiovascular, respiratory (COPD, emphysema), renal, liver, and gastrointestinal disease,
- •pregnant women,
- •patients younger than 18 years-
研究组 & 干预措施
placebo
The placebo group will receive intravenous infusion of normal saline only.
干预措施: Fentanyl (Drug)
dexmedetomidine
The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
干预措施: Dexmedetomidine (Drug)
dexmedetomidine
The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
干预措施: Fentanyl (Drug)
lidocaine
Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
干预措施: Lidocaine (Drug)
lidocaine
Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
干预措施: Fentanyl (Drug)
placebo
The placebo group will receive intravenous infusion of normal saline only.
干预措施: placebo (Other)
结局指标
主要结局
Consumption of Fentanyl
时间窗: time of the operation
consumption of fentanyl (mg) during the procedure
次要结局
- Consumption of Piritramide(one hour after the operation)
- Neuropathic Pain (Pain Questionnaire) dn4(two months after the surgery)
研究者
Lea Andjelkovic
MD
University Medical Centre Ljubljana
