Pain, Postoperative, Anesthesia Complication, Nausea, Vomiting, Ileus Paralytic, Hemodynamic Instability
Conditions
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.
Interventions
DRUGdexter ketamine
multimodal anesthesia without opioids ketamine as induction drug
DRUGLidocaine Hydrochloride
continuous infusion intravenous
DRUGFentanyl Hydrochloride
intravenous
clonidine intravenous pre induction
premedication
DRUGIsoflurane Volatile Liquid
maintenance of general anesthesia
DRUGRocuronium Injectable Solution
induction of general anesthesia
induction of general anesthesia
DRUGDexamethasone-21-Sulfobenzoate, Sodium Salt
at the end of the procedure 4mg IV
at the end of the procedure
at the end of the procedure
at the of the procedure
DRUGBupivacaine Hydrochloride
at the end of the procedure for infiltration of trocar wounds
Sponsors
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II
Exclusion criteria
* chronic use of opioids * Body mass index (BMI) \> 35 Kg.m-2 * Chronic heart failure, renal and hepatic failure * illicit drugs users * cognitive impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 60min after the surgery | will be asked pain at rest and movement and cough using the analog verbal scale of pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| pruritus | 12, 24 , 36 hours after surgery | yes or no, mild, moderate to serve |
| sedation | 12, 24 and 26 hours after surgery | will be use the Ramasay scale |
| time of discharge of PACU | 12 hour after the surgery | time when the patient will transfer to ward after the surgery |
| Hemodynamics effects | intraoperative | mean arterial pressure |
| nausea/ vomiting | 12, 24 and 36 hours after surgery | will be asked yes or not and how many times |
| height | Baseline | measure in cm |
| gender | Baseline | male or female |
| saturation of o2 | intraoperative | oximetry |
| ETCO2 | intraoperative | capnography |
| heart rate | intraoperative | heart rate |
| 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 |
| weight | Baseline | measure in kilogram |
Countries
Brazil
Outcome results
None listed