Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
The use of opioid during surgery can cause side effects and may delay hospital discharge. Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and and the time of discharge. In this compared controlled randomized study the aim is to evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting, postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care unit and hospital.
详细描述
Patients under laparoscopic cholecystectomy has moderate to severe pain. This study will compare intraoperative hemodynamic parameters under two techniques of general anesthesia: The primary outcome pain was used for planning the sample size of participants and considered a variation of 3 points on VAS (Visual analogic scale of pain). The secondaries outcomes nausea/vomiting, sedation, ileus paralytics, urinary retention, time of discharge (PACU) and hospital stay, and patient satisfaction will be recorded and analyzed.
the patients will be allocated from randomized program in one of the two arms.
- Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane
- Opioid sparing balance anesthesia with propofol, dexter- ketamine, clonidine, midazolan,isoflurane and lidocaine.
At the end of procedure both groups will receive dexamethasone, ranitidine
, ondansetron, keterolac IV and local infiltration of bupivacaine on trocar wounds as multimodal analgesia.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II
排除标准
- •chronic use of opioids
- •Body mass index (BMI) > 35 Kg.m-2
- •Chronic heart failure, renal and hepatic failure
- •illicit drugs users
- •cognitive impairments
研究组 & 干预措施
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: dexter ketamine (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Lidocaine Hydrochloride (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Clonidine Hydrochloride (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Midazolam Hydrochloride (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Isoflurane Volatile Liquid (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Rocuronium Injectable Solution (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Propofol 1 % Injectable Suspension (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Dexamethasone-21-Sulfobenzoate, Sodium Salt (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Ranitidine Hydrochloride (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Ondansetron Hydrochloride (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Ketorolac Injectable Solution (Drug)
GF general free
pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h
干预措施: Bupivacaine Hydrochloride (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Fentanyl Hydrochloride (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Midazolam Hydrochloride (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Isoflurane Volatile Liquid (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Rocuronium Injectable Solution (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Propofol 1 % Injectable Suspension (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Dexamethasone-21-Sulfobenzoate, Sodium Salt (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Ranitidine Hydrochloride (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Ondansetron Hydrochloride (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Ketorolac Injectable Solution (Drug)
GBal general balanced
pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
postoperative pain
时间窗: 60min after the surgery
will be asked pain at rest and movement and cough using the analog verbal scale of pain
次要结局
- height(Baseline)
- sedation(12, 24 and 26 hours after surgery)
- ETCO2(intraoperative)
- nausea/ vomiting(12, 24 and 36 hours after surgery)
- pruritus(12, 24 , 36 hours after surgery)
- Paralytic ileus(12, 24 and 36 hours after surgery)
- first analgesic rescue requirement(12 hours after the surgery)
- Hemodynamics effects(intraoperative)
- weight(Baseline)
- gender(Baseline)
- heart rate(intraoperative)
- time of discharge of PACU(12 hour after the surgery)
- pain(12, 24 and 36 hours after the procedure)
- saturation of o2(intraoperative)
研究者
Marcelo Vaz Perez
principal investigator
Faculdade de Ciências Médicas da Santa Casa de São Paulo