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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
multimodal anesthesia without opioids ketamine as induction drug
continuous infusion intravenous
intravenous
clonidine intravenous pre induction
premedication
maintenance of general anesthesia
induction of general anesthesia
induction of general anesthesia
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
at the end of the procedure for infiltration of trocar wounds
Faculdade de Ciências Médicas da Santa Casa de São Paulo
São Paulo, São Paulo, Brazil
Faculdade de Ciências Médicas da Santa Casa de São Paulo
São Paulo, São Paulo, Brazil
postoperative pain
will be asked pain at rest and movement and cough using the analog verbal scale of pain
Time frame: 60min after the surgery
nausea/ vomiting
will be asked yes or not and how many times
Time frame: 12, 24 and 36 hours after surgery
Paralytic ileus
will be access with ultrasound movement of intestine
Time frame: 12, 24 and 36 hours after surgery
first analgesic rescue requirement
the first analgesic given at PACU when the patient asked for it
Time frame: 12 hours after the surgery
pruritus
yes or no, mild, moderate to serve
Time frame: 12, 24 , 36 hours after surgery
sedation
will be use the Ramasay scale
Time frame: 12, 24 and 26 hours after surgery
time of discharge of PACU
time when the patient will transfer to ward after the surgery
Time frame: 12 hour after the surgery
Hemodynamics effects
mean arterial pressure
Time frame: intraoperative
weight
measure in kilogram
Time frame: Baseline
height
measure in cm
Time frame: Baseline
gender
male or female
Time frame: Baseline
saturation of o2
oximetry
Time frame: intraoperative
ETCO2
capnography
Time frame: intraoperative
heart rate
heart rate
Time frame: intraoperative
pain
will be asked pain at rest and movement and cough using the analog verbal scale of pain
Time frame: 12, 24 and 36 hours after the procedure
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