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

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marcelo Vaz Perez, principal investigator – Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Overall Official(s)
    • marcelo v perez, PhD, Principal Investigator, Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo

References

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.

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.

Citations Reporting on Results

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.

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