Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia

Ketamine

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.

Intervention / Treatment

  • dexter ketamine (DRUG)
    multimodal anesthesia without opioids ketamine as induction drug
  • Lidocaine Hydrochloride (DRUG)
    continuous infusion intravenous
  • Fentanyl Hydrochloride (DRUG)
    intravenous
  • Clonidine Hydrochloride (DRUG)
    clonidine intravenous pre induction
  • Midazolam Hydrochloride (DRUG)
    premedication
  • Isoflurane Volatile Liquid (DRUG)
    maintenance of general anesthesia
  • Rocuronium Injectable Solution (DRUG)
    induction of general anesthesia
  • Propofol 1 % Injectable Suspension (DRUG)
    induction of general anesthesia
  • Dexamethasone-21-Sulfobenzoate, Sodium Salt (DRUG)
    at the end of the procedure 4mg IV
  • Ranitidine Hydrochloride (DRUG)
    at the end of the procedure
  • Ondansetron Hydrochloride (DRUG)
    at the end of the procedure
  • Ketorolac Injectable Solution (DRUG)
    at the of the procedure
  • Bupivacaine Hydrochloride (DRUG)
    at the end of the procedure for infiltration of trocar wounds

Condition or Disease

  • Pain, Postoperative
  • Anesthesia Complication
  • Nausea
  • Vomiting
  • Ileus Paralytic
  • Hemodynamic Instability

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 30 Years to 70 Years
    Enrollment: 40 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Nov 01, 2016
    Primary Completion: Nov 01, 2016 ESTIMATED
    Completion Date: Mar 01, 2017 ESTIMATED
    Study First Posted: Nov 02, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 03, 2016

    Sponsors / Collaborators

    Lead Sponsor: Federal University of São Paulo
    Responsible Party: N/A

    Location

    Sao Paulo, Brazil

    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.

    Participant Groups

    • 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

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 30
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • will be asked pain at rest and movement and cough using the analog verbal scale of pain

    Secondary Outcomes

    • will be asked yes or not and how many times

    • will be access with ultrasound movement of intestine

    • the first analgesic given at PACU when the patient asked for it

    • yes or no, mild, moderate to serve

    • will be use the Ramasay scale

    • time when the patient will transfer to ward after the surgery

    • mean arterial pressure

    • measure in kilogram

    • measure in cm

    • male or female

    • oximetry

    • capnography

    • heart rate

    • will be asked pain at rest and movement and cough using the analog verbal scale of pain

    More Details

    NCT Number: NCT02953210
    Acronym: GALOFF
    Other IDs: opioid free anesthesia
    Study URL: https://clinicaltrials.gov/study/NCT02953210
    Last updated: Sep 29, 2023