- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: dexter ketamine
- Drug: Lidocaine Hydrochloride
- Drug: Clonidine Hydrochloride
- Drug: Midazolam Hydrochloride
- Drug: Isoflurane Volatile Liquid
- Drug: Rocuronium Injectable Solution
- Drug: Propofol 1 % Injectable Suspension
- Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt
- Drug: Ranitidine Hydrochloride
- Drug: Ondansetron Hydrochloride
- Drug: Ketorolac Injectable Solution
- Drug: Bupivacaine Hydrochloride
- Drug: Fentanyl Hydrochloride
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.
- Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Sao Paulo, Brazil, 01221-020
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
-
Sao Paulo, Brazil, 01333000
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
multimodal anesthesia without opioids ketamine as induction drug
Other Names:
continuous infusion intravenous
Other Names:
clonidine intravenous pre induction
Other Names:
premedication
maintenance of general anesthesia
Other Names:
induction of general anesthesia
Other Names:
induction of general anesthesia
Other Names:
at the end of the procedure 4mg IV
at the end of the procedure
at the end of the procedure
Other Names:
at the of the procedure
Other Names:
at the end of the procedure for infiltration of trocar wounds
Other Names:
|
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
|
premedication
maintenance of general anesthesia
Other Names:
induction of general anesthesia
Other Names:
induction of general anesthesia
Other Names:
at the end of the procedure 4mg IV
at the end of the procedure
at the end of the procedure
Other Names:
at the of the procedure
Other Names:
at the end of the procedure for infiltration of trocar wounds
Other Names:
intravenous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
60min after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nausea/ vomiting
Time Frame: 12, 24 and 36 hours after surgery
|
will be asked yes or not and how many times
|
12, 24 and 36 hours after surgery
|
Paralytic ileus
Time Frame: 12, 24 and 36 hours after surgery
|
will be access with ultrasound movement of intestine
|
12, 24 and 36 hours after surgery
|
first analgesic rescue requirement
Time Frame: 12 hours after the surgery
|
the first analgesic given at PACU when the patient asked for it
|
12 hours after the surgery
|
pruritus
Time Frame: 12, 24 , 36 hours after surgery
|
yes or no, mild, moderate to serve
|
12, 24 , 36 hours after surgery
|
sedation
Time Frame: 12, 24 and 26 hours after surgery
|
will be use the Ramasay scale
|
12, 24 and 26 hours after surgery
|
time of discharge of PACU
Time Frame: 12 hour after the surgery
|
time when the patient will transfer to ward after the surgery
|
12 hour after the surgery
|
Hemodynamics effects
Time Frame: intraoperative
|
mean arterial pressure
|
intraoperative
|
weight
Time Frame: Baseline
|
measure in kilogram
|
Baseline
|
height
Time Frame: Baseline
|
measure in cm
|
Baseline
|
gender
Time Frame: Baseline
|
male or female
|
Baseline
|
saturation of o2
Time Frame: intraoperative
|
oximetry
|
intraoperative
|
ETCO2
Time Frame: intraoperative
|
capnography
|
intraoperative
|
heart rate
Time Frame: intraoperative
|
heart rate
|
intraoperative
|
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
|
12, 24 and 36 hours after the procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: marcelo v perez, PhD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Pain, Postoperative
- Vomiting
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Dermatologic Agents
- Analgesics, Opioid
- Narcotics
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Antagonists
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anti-Ulcer Agents
- Anesthetics, Inhalation
- Neuromuscular Agents
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Sympatholytics
- Histamine H2 Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Ketamine
- Dexamethasone
- Fentanyl
- Midazolam
- Propofol
- Lidocaine
- Ketorolac
- Pharmaceutical Solutions
- Bupivacaine
- Clonidine
- Rocuronium
- Ranitidine
- Ranitidine bismuth citrate
- Ondansetron
- Isoflurane
Other Study ID Numbers
- opioid free anesthesia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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