Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
NCT ID: NCT05887258
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2022-05-15
2024-06-15
Brief Summary
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Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).
The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.
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Detailed Description
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Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.
Other variables evaluated will be postoperative complications:
* Postoperative hypoxemia.
* Incidence of postoperative nausea and vomiting (PONV).
* Postoperative ileus.
* surgical complications.
* medical complications
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Opioid free anesthesia (OFA)
This arm is administered by the anesthesiologist in charge of the operating room.
It is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar).
Opioid free anesthesia
It administers a combination of drugs to replace the opioid derivatives. Among them, we will use lidocaine, ketamine, dexmetomidine, and magnesium sulfate in continuous infusion adjusted to the patient's weight during surgery.
Opioid based Anesthesia (OA)
This arm is administered by the anesthesiologist in charge of the operating room.
This arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine.
Opioid based Anesthesia
administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.
Interventions
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Opioid free anesthesia
It administers a combination of drugs to replace the opioid derivatives. Among them, we will use lidocaine, ketamine, dexmetomidine, and magnesium sulfate in continuous infusion adjusted to the patient's weight during surgery.
Opioid based Anesthesia
administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
(-) Patients scheduled for laparoscopic colorectal surgery.
(-) Patients with physical status classification (ASA) I-III.
(- ) Patients who have signed the informed consent of the clinical trial
Exclusion Criteria
(-)Patients with allergy to any of the drugs or excipients used in the study
(-) Emergency laparoscopic colorectal surgery
(-) Patients with AV block, intraventricular block, or sinus block
(-) Adam-Stokes syndrome.
(-) Patient on chronic beta-blocker treatment with HR \< 50 bpm
(-) Patient with ejection fraction \< 40% known
(-) Epilepsy.
(-) Surgery converted to open surgery
(-) Legally disabled patient
(-) Patients with physical status classification (ASA) IV.
18 Years
ALL
No
Sponsors
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Osakidetza
OTHER
Unai Ortega Mera
OTHER
Responsible Party
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Unai Ortega Mera
Principal Investigator
Principal Investigators
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Unai Ortega, MD
Role: PRINCIPAL_INVESTIGATOR
Osakidetza
Locations
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Hospital de Galdakao
Galdakao, Vizcaya, Spain
Countries
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Other Identifiers
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2021-003245-38
Identifier Type: -
Identifier Source: org_study_id
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