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Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309879
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Fabricio Tavares Mendonca, Hospital de Base

Brief Summary:
This study aims to compare the quality of perioperative analgesia of lidocaine, magnesium sulphate and remifentanil in patients undergoing mastectomy

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Remifentanil infusion Drug: Lidocaine infusion Drug: Magnesium sulphate infusion Drug: Magnesium sulphate and Lidocaine infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Infusion of Lidocaine, Magnesium Sulphate and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized and Double-blind Study
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Active Comparator: Remifentanil group
Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Drug: Remifentanil infusion
Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Other Name: Remifentanil hydrochloride

Drug: Lidocaine infusion
Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Other Name: Lidocaine hydrochloride

Drug: Magnesium sulphate infusion
Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Other Name: Magnesium sulphate

Drug: Magnesium sulphate and Lidocaine infusion
Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
Other Name: Magnesium sulphate, Lidocaine hydrochloride

Active Comparator: Lidocaine group
Patients in lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Drug: Remifentanil infusion
Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Other Name: Remifentanil hydrochloride

Drug: Lidocaine infusion
Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Other Name: Lidocaine hydrochloride

Drug: Magnesium sulphate infusion
Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Other Name: Magnesium sulphate

Drug: Magnesium sulphate and Lidocaine infusion
Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
Other Name: Magnesium sulphate, Lidocaine hydrochloride

Active Comparator: Magnesium group
Patients in lidocaine group received an intravenous bolus injection of 50 mg/kg magnesium sulphate followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Drug: Remifentanil infusion
Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Other Name: Remifentanil hydrochloride

Drug: Lidocaine infusion
Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Other Name: Lidocaine hydrochloride

Drug: Magnesium sulphate infusion
Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Other Name: Magnesium sulphate

Drug: Magnesium sulphate and Lidocaine infusion
Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
Other Name: Magnesium sulphate, Lidocaine hydrochloride

Active Comparator: Magnesium and Lidocaine group
Patients received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
Drug: Remifentanil infusion
Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
Other Name: Remifentanil hydrochloride

Drug: Lidocaine infusion
Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
Other Name: Lidocaine hydrochloride

Drug: Magnesium sulphate infusion
Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
Other Name: Magnesium sulphate

Drug: Magnesium sulphate and Lidocaine infusion
Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
Other Name: Magnesium sulphate, Lidocaine hydrochloride




Primary Outcome Measures :
  1. Analgesics consumption in post-operative [ Time Frame: Within the first 24 hours after surgery ]
    Qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them


Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: Within the first 24 hours after surgery ]
    Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or unbearable pain)

  2. Pain Scores on the Verbal Rating Scale [ Time Frame: Within the first 24 hours after surgery ]
    Verbal Rating Scale (VRS), consisting of a list of phrases (no pain, mild pain, moderate pain, intense pain, maximum pain)

  3. Anesthetic consumption during surgery [ Time Frame: During the surgery ]
    amount of intravenous and inhalational anesthetics consumed during surgery

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: During the surgery ]
    Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Within the first 24 hours after surgery ]
    Incidence of adverse effects such as time of awakening, nausea, vomiting, pruritus, urinary retention, drowsiness



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients scheduled for elective surgery performed mastectomy;
  • Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);

Exclusion Criteria:

  • Patients with less than 18 years and above 75 years of age;
  • Patients who are allergic to morphine and / or lidocaine and / or remifentanil and / or magnesium sulphate;
  • Patients with chronic pain;
  • Patients with severe hepatic disease;
  • Patients with severe renal disease;
  • Patients with neurological disorders;
  • Patients included in other clinical currently or within the past three months under general anesthesia studies;
  • Patients who refuse to participate in the study;
  • Any other condition that in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309879


Locations
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Brazil
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70680250
Sponsors and Collaborators
Hospital de Base
Investigators
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Principal Investigator: Fabricio T Mendonca, MD, TSA Hospital de Base do Distrito Federal, Brazil

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabricio Tavares Mendonca, MD, TSA, Hospital de Base
ClinicalTrials.gov Identifier: NCT02309879    
Other Study ID Numbers: LidovsMgvsRemi
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Fabricio Tavares Mendonca, Hospital de Base:
Intravenous lidocaine
Magnesium sulphate
Mastectomy
Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Magnesium Sulfate
Remifentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents