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

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Vomiting; Nausea; Hemodynamic Instability; Pain, Postoperative; Ileus Paralytic; Anesthesia Complication

Treatments: Drug: Ranitidine Hydrochloride; Drug: Bupivacaine Hydrochloride; Drug: Clonidine Hydrochloride; Drug: Propofol 1 % Injectable Suspension; Drug: Isoflurane Volatile Liquid; Drug: dexter ketamine; Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt; Drug: Midazolam Hydrochloride; Drug: Fentanyl Hydrochloride; Drug: Lidocaine Hydrochloride; Drug: Ondansetron Hydrochloride; Drug: Ketorolac Injectable Solution; Drug: Rocuronium Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02953210

opioid free anesthesia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

GF general free

Experimental group

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

Treatment:

Drug: Rocuronium Injectable Solution

Drug: Ketorolac Injectable Solution

Drug: Ranitidine Hydrochloride

Drug: Ondansetron Hydrochloride

Drug: Lidocaine Hydrochloride

Drug: Midazolam Hydrochloride

Drug: dexter ketamine

Drug: Isoflurane Volatile Liquid

Drug: Propofol 1 % Injectable Suspension

Drug: Clonidine Hydrochloride

Drug: Bupivacaine Hydrochloride

Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt

GBal general balanced

Active Comparator group

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

Treatment:

Drug: Rocuronium Injectable Solution

Drug: Ketorolac Injectable Solution

Drug: Ranitidine Hydrochloride

Drug: Ondansetron Hydrochloride

Drug: Fentanyl Hydrochloride

Drug: Midazolam Hydrochloride

Drug: Isoflurane Volatile Liquid

Drug: Propofol 1 % Injectable Suspension

Drug: Bupivacaine Hydrochloride

Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt