NCT02953210

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-11-01
• Completion: 2017-03-01
• First posted: 2016-11-02
• Last updated: 2016-11-04

Locations

2 sites across 1 country: Brazil