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

NCT02953210 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

dexter ketamine

multimodal anesthesia without opioids ketamine as induction drug

DRUG

Lidocaine Hydrochloride

continuous infusion intravenous

DRUG

Fentanyl Hydrochloride

intravenous

DRUG

Clonidine Hydrochloride

clonidine intravenous pre induction

DRUG

Midazolam Hydrochloride

premedication

DRUG

Isoflurane Volatile Liquid

maintenance of general anesthesia

DRUG

Rocuronium Injectable Solution

induction of general anesthesia

DRUG

Propofol 1 % Injectable Suspension

induction of general anesthesia

DRUG

Dexamethasone-21-Sulfobenzoate, Sodium Salt

at the end of the procedure 4mg IV

DRUG

Ranitidine Hydrochloride

at the end of the procedure

DRUG

Ondansetron Hydrochloride

at the end of the procedure

DRUG

Ketorolac Injectable Solution

at the of the procedure

DRUG

Bupivacaine Hydrochloride

at the end of the procedure for infiltration of trocar wounds

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    collaborator OTHER
  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • marcelo v perez, PhD · Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-11-30
Completion
2017-03-31

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953210 on ClinicalTrials.gov