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

Primary Purpose

Pain, Postoperative, Anesthesia Complication, Nausea

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
dexter ketamine
Lidocaine Hydrochloride
Fentanyl Hydrochloride
Clonidine Hydrochloride
Midazolam Hydrochloride
Isoflurane Volatile Liquid
Rocuronium Injectable Solution
Propofol 1 % Injectable Suspension
Dexamethasone-21-Sulfobenzoate, Sodium Salt
Ranitidine Hydrochloride
Ondansetron Hydrochloride
Ketorolac Injectable Solution
Bupivacaine Hydrochloride
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GF general free

GBal general balanced

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

nausea/ vomiting
will be asked yes or not and how many times
Paralytic ileus
will be access with ultrasound movement of intestine
first analgesic rescue requirement
the first analgesic given at PACU when the patient asked for it
pruritus
yes or no, mild, moderate to serve
sedation
will be use the Ramasay scale
time of discharge of PACU
time when the patient will transfer to ward after the surgery
Hemodynamics effects
mean arterial pressure
weight
measure in kilogram
height
measure in cm
gender
male or female
saturation of o2
oximetry
ETCO2
capnography
heart rate
heart rate
pain
will be asked pain at rest and movement and cough using the analog verbal scale of pain

Full Information

First Posted
October 26, 2016
Last Updated
November 3, 2016
Sponsor
Federal University of São Paulo
Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02953210
Brief Title
Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia
Acronym
GALOFF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia Complication, Nausea, Vomiting, Ileus Paralytic, Hemodynamic Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GF general free
Arm Type
Experimental
Arm Description
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
Arm Title
GBal general balanced
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
dexter ketamine
Other Intervention Name(s)
ketamine plus
Intervention Description
multimodal anesthesia without opioids ketamine as induction drug
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
xylocaine
Intervention Description
continuous infusion intravenous
Intervention Type
Drug
Intervention Name(s)
Fentanyl Hydrochloride
Other Intervention Name(s)
Fentanil
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Clonidine Hydrochloride
Other Intervention Name(s)
Catapres
Intervention Description
clonidine intravenous pre induction
Intervention Type
Drug
Intervention Name(s)
Midazolam Hydrochloride
Intervention Description
premedication
Intervention Type
Drug
Intervention Name(s)
Isoflurane Volatile Liquid
Other Intervention Name(s)
isoflurane
Intervention Description
maintenance of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Rocuronium Injectable Solution
Other Intervention Name(s)
rocuronium
Intervention Description
induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol 1 % Injectable Suspension
Other Intervention Name(s)
propofol
Intervention Description
induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone-21-Sulfobenzoate, Sodium Salt
Intervention Description
at the end of the procedure 4mg IV
Intervention Type
Drug
Intervention Name(s)
Ranitidine Hydrochloride
Intervention Description
at the end of the procedure
Intervention Type
Drug
Intervention Name(s)
Ondansetron Hydrochloride
Other Intervention Name(s)
ondasetron
Intervention Description
at the end of the procedure
Intervention Type
Drug
Intervention Name(s)
Ketorolac Injectable Solution
Other Intervention Name(s)
keterolac
Intervention Description
at the of the procedure
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
bupivacaine
Intervention Description
at the end of the procedure for infiltration of trocar wounds
Primary Outcome Measure Information:
Title
postoperative pain
Description
will be asked pain at rest and movement and cough using the analog verbal scale of pain
Time Frame
60min after the surgery
Secondary Outcome Measure Information:
Title
nausea/ vomiting
Description
will be asked yes or not and how many times
Time Frame
12, 24 and 36 hours after surgery
Title
Paralytic ileus
Description
will be access with ultrasound movement of intestine
Time Frame
12, 24 and 36 hours after surgery
Title
first analgesic rescue requirement
Description
the first analgesic given at PACU when the patient asked for it
Time Frame
12 hours after the surgery
Title
pruritus
Description
yes or no, mild, moderate to serve
Time Frame
12, 24 , 36 hours after surgery
Title
sedation
Description
will be use the Ramasay scale
Time Frame
12, 24 and 26 hours after surgery
Title
time of discharge of PACU
Description
time when the patient will transfer to ward after the surgery
Time Frame
12 hour after the surgery
Title
Hemodynamics effects
Description
mean arterial pressure
Time Frame
intraoperative
Title
weight
Description
measure in kilogram
Time Frame
Baseline
Title
height
Description
measure in cm
Time Frame
Baseline
Title
gender
Description
male or female
Time Frame
Baseline
Title
saturation of o2
Description
oximetry
Time Frame
intraoperative
Title
ETCO2
Description
capnography
Time Frame
intraoperative
Title
heart rate
Description
heart rate
Time Frame
intraoperative
Title
pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marcelo v perez, PhD
Organizational Affiliation
Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Ciências Médicas da Santa Casa de São Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Faculdade de Ciências Médicas da Santa Casa de São Paulo
City
Sao Paulo
ZIP/Postal Code
01333000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16571981
Citation
Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.
Results Reference
background
PubMed Identifier
22584558
Citation
De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.
Results Reference
background
PubMed Identifier
17959952
Citation
Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.
Results Reference
result

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

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