Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia
- Conditions
- VomitingAnesthesia ComplicationHemodynamic InstabilityPain, PostoperativeIleus ParalyticNausea
- Interventions
- Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt
- Registration Number
- NCT02953210
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
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.
- Detailed Description
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.
1. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane
2. 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.
General anesthesia opioid free seems to have less side effects than the general anesthesia based on opioid this study will compare it.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II
- chronic use of opioids
- Body mass index (BMI) > 35 Kg.m-2
- Chronic heart failure, renal and hepatic failure
- illicit drugs users
- cognitive impairments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GBal general balanced Ondansetron Hydrochloride 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 GF general free Propofol 1 % Injectable Suspension 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 GBal general balanced Ketorolac Injectable Solution 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 GF general free Rocuronium Injectable Solution 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 GBal general balanced Rocuronium Injectable Solution 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 GBal general balanced Ranitidine Hydrochloride 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 GF general free Midazolam Hydrochloride 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 GF general free Ketorolac Injectable Solution 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 GBal general balanced Fentanyl Hydrochloride 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 GF general free dexter ketamine 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 GF general free Isoflurane Volatile Liquid 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 GF general free Dexamethasone-21-Sulfobenzoate, Sodium Salt 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 GBal general balanced Midazolam Hydrochloride 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 GBal general balanced Propofol 1 % Injectable Suspension 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 GBal general balanced Dexamethasone-21-Sulfobenzoate, Sodium Salt 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 GBal general balanced Isoflurane Volatile Liquid 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 GF general free Clonidine Hydrochloride 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 GF general free Ondansetron Hydrochloride 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 GF general free Ranitidine Hydrochloride 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 GF general free Lidocaine Hydrochloride 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 GF general free Bupivacaine Hydrochloride 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 GBal general balanced Bupivacaine Hydrochloride 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
- Primary Outcome Measures
Name Time Method postoperative pain 60min after the surgery will be asked pain at rest and movement and cough using the analog verbal scale of pain
- Secondary Outcome Measures
Name Time Method nausea/ vomiting 12, 24 and 36 hours after surgery will be asked yes or not and how many times
sedation 12, 24 and 26 hours after surgery will be use the Ramasay scale
ETCO2 intraoperative capnography
pruritus 12, 24 , 36 hours after surgery yes or no, mild, moderate to serve
height Baseline measure in cm
Paralytic ileus 12, 24 and 36 hours after surgery will be access with ultrasound movement of intestine
first analgesic rescue requirement 12 hours after the surgery the first analgesic given at PACU when the patient asked for it
Hemodynamics effects intraoperative mean arterial pressure
weight Baseline measure in kilogram
gender Baseline male or female
heart rate intraoperative heart rate
time of discharge of PACU 12 hour after the surgery time when the patient will transfer to ward after the surgery
pain 12, 24 and 36 hours after the procedure will be asked pain at rest and movement and cough using the analog verbal scale of pain
saturation of o2 intraoperative oximetry
Trial Locations
- Locations (1)
Faculdade de Ciências Médicas da Santa Casa de São Paulo
🇧🇷Sao Paulo, Brazil