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
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 8 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE4
-
Sep 2025 — Present [monthly]
Unknown PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE4
▶ Show 3 earlier versions
-
Dec 2018 — Jan 2021 [monthly]
Unknown Status PHASE4
Status: Enrolling By Invitation → Unknown Status
-
Jun 2018 — Dec 2018 [monthly]
Enrolling By Invitation PHASE4
-
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
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Federal University of São Paulo
For direct contact, visit the study record on ClinicalTrials.gov .