Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia (GALOFF)

November 3, 2016 updated by: Marcelo Vaz Perez, Federal University of São Paulo

Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 01221-020
        • Faculdade de Ciências Médicas da Santa Casa de São Paulo
      • Sao Paulo, Brazil, 01333000
        • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GF general free
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
multimodal anesthesia without opioids ketamine as induction drug
Other Names:
  • ketamine plus
continuous infusion intravenous
Other Names:
  • xylocaine
clonidine intravenous pre induction
Other Names:
  • Catapres
premedication
maintenance of general anesthesia
Other Names:
  • isoflurane
induction of general anesthesia
Other Names:
  • rocuronium
induction of general anesthesia
Other Names:
  • propofol
at the end of the procedure 4mg IV
at the end of the procedure
at the end of the procedure
Other Names:
  • ondasetron
at the of the procedure
Other Names:
  • keterolac
at the end of the procedure for infiltration of trocar wounds
Other Names:
  • bupivacaine
Active Comparator: GBal general balanced
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
premedication
maintenance of general anesthesia
Other Names:
  • isoflurane
induction of general anesthesia
Other Names:
  • rocuronium
induction of general anesthesia
Other Names:
  • propofol
at the end of the procedure 4mg IV
at the end of the procedure
at the end of the procedure
Other Names:
  • ondasetron
at the of the procedure
Other Names:
  • keterolac
at the end of the procedure for infiltration of trocar wounds
Other Names:
  • bupivacaine
intravenous
Other Names:
  • Fentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 60min after the surgery
will be asked pain at rest and movement and cough using the analog verbal scale of pain
60min after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea/ vomiting
Time Frame: 12, 24 and 36 hours after surgery
will be asked yes or not and how many times
12, 24 and 36 hours after surgery
Paralytic ileus
Time Frame: 12, 24 and 36 hours after surgery
will be access with ultrasound movement of intestine
12, 24 and 36 hours after surgery
first analgesic rescue requirement
Time Frame: 12 hours after the surgery
the first analgesic given at PACU when the patient asked for it
12 hours after the surgery
pruritus
Time Frame: 12, 24 , 36 hours after surgery
yes or no, mild, moderate to serve
12, 24 , 36 hours after surgery
sedation
Time Frame: 12, 24 and 26 hours after surgery
will be use the Ramasay scale
12, 24 and 26 hours after surgery
time of discharge of PACU
Time Frame: 12 hour after the surgery
time when the patient will transfer to ward after the surgery
12 hour after the surgery
Hemodynamics effects
Time Frame: intraoperative
mean arterial pressure
intraoperative
weight
Time Frame: Baseline
measure in kilogram
Baseline
height
Time Frame: Baseline
measure in cm
Baseline
gender
Time Frame: Baseline
male or female
Baseline
saturation of o2
Time Frame: intraoperative
oximetry
intraoperative
ETCO2
Time Frame: intraoperative
capnography
intraoperative
heart rate
Time Frame: intraoperative
heart rate
intraoperative
pain
Time Frame: 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
12, 24 and 36 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: marcelo v perez, PhD, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • opioid free anesthesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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