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

NCT ID: NCT02953210

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Anesthesia Complication Nausea Vomiting Ileus Paralytic Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

dexter ketamine

Intervention Type DRUG

multimodal anesthesia without opioids ketamine as induction drug

Lidocaine Hydrochloride

Intervention Type DRUG

continuous infusion intravenous

Clonidine Hydrochloride

Intervention Type DRUG

clonidine intravenous pre induction

Midazolam Hydrochloride

Intervention Type DRUG

premedication

Isoflurane Volatile Liquid

Intervention Type DRUG

maintenance of general anesthesia

Rocuronium Injectable Solution

Intervention Type DRUG

induction of general anesthesia

Propofol 1 % Injectable Suspension

Intervention Type DRUG

induction of general anesthesia

Dexamethasone-21-Sulfobenzoate, Sodium Salt

Intervention Type DRUG

at the end of the procedure 4mg IV

Ranitidine Hydrochloride

Intervention Type DRUG

at the end of the procedure

Ondansetron Hydrochloride

Intervention Type DRUG

at the end of the procedure

Ketorolac Injectable Solution

Intervention Type DRUG

at the of the procedure

Bupivacaine Hydrochloride

Intervention Type DRUG

at the end of the procedure for infiltration of trocar wounds

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

Group Type ACTIVE_COMPARATOR

Fentanyl Hydrochloride

Intervention Type DRUG

intravenous

Midazolam Hydrochloride

Intervention Type DRUG

premedication

Isoflurane Volatile Liquid

Intervention Type DRUG

maintenance of general anesthesia

Rocuronium Injectable Solution

Intervention Type DRUG

induction of general anesthesia

Propofol 1 % Injectable Suspension

Intervention Type DRUG

induction of general anesthesia

Dexamethasone-21-Sulfobenzoate, Sodium Salt

Intervention Type DRUG

at the end of the procedure 4mg IV

Ranitidine Hydrochloride

Intervention Type DRUG

at the end of the procedure

Ondansetron Hydrochloride

Intervention Type DRUG

at the end of the procedure

Ketorolac Injectable Solution

Intervention Type DRUG

at the of the procedure

Bupivacaine Hydrochloride

Intervention Type DRUG

at the end of the procedure for infiltration of trocar wounds

Interventions

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dexter ketamine

multimodal anesthesia without opioids ketamine as induction drug

Intervention Type DRUG

Lidocaine Hydrochloride

continuous infusion intravenous

Intervention Type DRUG

Fentanyl Hydrochloride

intravenous

Intervention Type DRUG

Clonidine Hydrochloride

clonidine intravenous pre induction

Intervention Type DRUG

Midazolam Hydrochloride

premedication

Intervention Type DRUG

Isoflurane Volatile Liquid

maintenance of general anesthesia

Intervention Type DRUG

Rocuronium Injectable Solution

induction of general anesthesia

Intervention Type DRUG

Propofol 1 % Injectable Suspension

induction of general anesthesia

Intervention Type DRUG

Dexamethasone-21-Sulfobenzoate, Sodium Salt

at the end of the procedure 4mg IV

Intervention Type DRUG

Ranitidine Hydrochloride

at the end of the procedure

Intervention Type DRUG

Ondansetron Hydrochloride

at the end of the procedure

Intervention Type DRUG

Ketorolac Injectable Solution

at the of the procedure

Intervention Type DRUG

Bupivacaine Hydrochloride

at the end of the procedure for infiltration of trocar wounds

Intervention Type DRUG

Other Intervention Names

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ketamine plus xylocaine Fentanil Catapres isoflurane rocuronium propofol ondasetron keterolac bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Vaz Perez

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marcelo v perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo

Locations

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 16571981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22584558 (View on PubMed)

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.

Reference Type RESULT
PMID: 17959952 (View on PubMed)

Other Identifiers

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opioid free anesthesia

Identifier Type: -

Identifier Source: org_study_id