deltatrials
Unknown PHASE4 INTERVENTIONAL 2-arm NCT02953210

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

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

Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Conditions Anesthesia Complication Hemodynamic Instability Ileus Paralytic Nausea Pain, Postoperative Vomiting
Interventions Bupivacaine Hydrochloride Clonidine Hydrochloride Dexamethasone-21-Sulfobenzoate, Sodium Salt Fentanyl Hydrochloride Isoflurane Volatile Liquid Ketorolac Injectable Solution Lidocaine Hydrochloride Midazolam Hydrochloride Ondansetron Hydrochloride Propofol 1 % Injectable Suspension Ranitidine Hydrochloride Rocuronium Injectable Solution dexter ketamine
Updated 7 times since 2017 Last updated: Nov 3, 2016 Started: Nov 30, 2016 Primary completion: Nov 30, 2016 Completion: Mar 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Anesthesia Complication and Hemodynamic Instability, this trial is ongoing. The trial is conducted by Faculdade de Ciências Médicas da Santa Casa de São Paulo and has accumulated 7 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotEnrolling By Invitation~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotEnrolling By Invitation~Dec 2018 – ~Jan 2021 · 25 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 12 months · monthly snapshotUnknown

Change History

7 versions recorded

  1. Sep 2025 — Present [monthly]

    Unknown PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE4

    Status: Unknown Status → Unknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE4

  5. Dec 2018 — Jan 2021 [monthly]

    Unknown Status PHASE4

    Status: Enrolling By Invitation → Unknown Status

▶ Show 2 earlier versions

  1. Jun 2018 — Dec 2018 [monthly]

    Enrolling By Invitation PHASE4

  2. Jan 2017 — Jun 2018 [monthly]

    Enrolling By Invitation PHASE4

    First recorded

Nov 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Federal University of São Paulo
Data source: Federal University of São Paulo

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations