Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy
NCT ID: NCT06642649
Last Updated: 2025-02-28
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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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-11-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl
Every patient will receive, before induction of general anesthesia as in control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5% and morphine sulfate 100 mcg.
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)
General anesthesia + spinal anesthesia with local anesthetic and morfine
study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl
every patient will receive, before induction of general anesthesia, as in the control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5%, morphine sulfate 100 mcg and fentanyl 20 mcg.
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl
study intervention NO spinal
Every patient will receive a general anesthesia induced with propofol (1.5-2.5 mg/kg, individually adjusted), rocuronium (0.6 mg/kg) for muscle relaxation and a continuous infusion of remifentanil (0.05-0.3 mcg/kg/min, depending on the clinical characteristics of the patient). General anesthesia was maintained with a continuous infusion of propofol (4-8 mg/kg/h), and the infusion of remifentanil which was started with the induction. Fractionated doses of rocuronium were administered based on TOF monitoring (train of four) to maintain muscle relaxation.
General Anesthesia (control group)
Only General Anestesia
Interventions
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General Anesthesia (control group)
Only General Anestesia
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)
General anesthesia + spinal anesthesia with local anesthetic and morfine
General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl
Eligibility Criteria
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Inclusion Criteria
* ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)
Exclusion Criteria
* patient refusal,
* contraindication to spinal anesthesia (e.g., hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis, coagulopathies or ongoing anticoagulant therapy),
* known chronic pain syndrome, known
* suspected non- compliance,
* drug, or alcohol abuse ,
* major oncological surgeries,
* allergy to drugs used in the protocol,
* previous chronic use of analgesics
* history of opioid abuse
18 Years
FEMALE
No
Sponsors
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Andrea Saporito
OTHER
Responsible Party
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Andrea Saporito
Head of Anesthesiology, Prof.Dr.Med.
Principal Investigators
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Andrea Saporito, Anesth
Role: STUDY_CHAIR
Ente Ospedaliero Cantonale, Bellinzona
Locations
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Ente Ospedaliero Cantonale ORBV
Bellinzona, Switzerland, Switzerland
Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LpsSa
Identifier Type: -
Identifier Source: org_study_id
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