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The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Metoprolol
Normal saline
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective breast surgery due to breast cancer
  • Voluntary
  • BMI ≥ 18 and ≤ 35 kg/m2
  • ASA 1-3
  • No regular use of beta-blockers or during the last 72 hours
  • No contraindications to beta-blockers

Exclusion Criteria:

  • Pregnancy or breast feeding
  • AV-block, degree II or III
  • Untreated cardiac insufficiency
  • Sinus bradycardia, heart rate < 45 / min or symptoms
  • Sick sinus syndrome
  • Cardiogenic shock
  • Severe peripheral vascular disorder
  • Systolic blood pressure < 100 mmHg
  • Long PQ-time, > 0,24 seconds
  • Known hypersensitivity to beta-blockers or the ingredients of the drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Metoprolol

    Normal saline

    Arm Description

    Metoprolol infusion

    Equal volume of saline.

    Outcomes

    Primary Outcome Measures

    Anaesthesia
    Total consumption of desflurane
    Anaesthesia
    Total consumption of remifentanil
    Postoperative pain
    Total analgesics consumption
    Postoperative pain
    Time to analgesics
    Postoperative pain
    Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
    Long-term pain
    The incidence and the level of pain at 3 months
    Long-term pain
    The incidence and the level of pain at 12 months

    Secondary Outcome Measures

    Safety and tolerability
    Number of patients with adverse effects
    Distribution to the central nervous system
    Cerebro spinal fluid and blood samples
    Life satisfaction
    Life satisfaction in a Likerts scale
    Anxiety
    Spielberg State-Trait Anxiety Inventory
    Depression
    Beck Depression Inventory

    Full Information

    First Posted
    September 19, 2014
    Last Updated
    March 21, 2018
    Sponsor
    Kuopio University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02269696
    Brief Title
    The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
    Official Title
    The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn
    Study Start Date
    March 21, 2018 (Anticipated)
    Primary Completion Date
    March 21, 2018 (Anticipated)
    Study Completion Date
    March 21, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kuopio University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated.
    Detailed Description
    The purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. Adverse effects will be recorded as safety measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metoprolol
    Arm Type
    Experimental
    Arm Description
    Metoprolol infusion
    Arm Title
    Normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    Equal volume of saline.
    Intervention Type
    Drug
    Intervention Name(s)
    Metoprolol
    Other Intervention Name(s)
    Seloken
    Intervention Description
    Intraoperative metoprolol infusion.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    NaCl 0,9%
    Intervention Description
    Equal of volume compared to metoprolol.
    Primary Outcome Measure Information:
    Title
    Anaesthesia
    Description
    Total consumption of desflurane
    Time Frame
    Intraoperative
    Title
    Anaesthesia
    Description
    Total consumption of remifentanil
    Time Frame
    Intraoperative
    Title
    Postoperative pain
    Description
    Total analgesics consumption
    Time Frame
    First 4 postoperative hours
    Title
    Postoperative pain
    Description
    Time to analgesics
    Time Frame
    First 4 postoperative hours
    Title
    Postoperative pain
    Description
    Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
    Time Frame
    First 4 postoperative hours
    Title
    Long-term pain
    Description
    The incidence and the level of pain at 3 months
    Time Frame
    3 months
    Title
    Long-term pain
    Description
    The incidence and the level of pain at 12 months
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability
    Description
    Number of patients with adverse effects
    Time Frame
    Perioperative
    Title
    Distribution to the central nervous system
    Description
    Cerebro spinal fluid and blood samples
    Time Frame
    Perioperative
    Title
    Life satisfaction
    Description
    Life satisfaction in a Likerts scale
    Time Frame
    1 year
    Title
    Anxiety
    Description
    Spielberg State-Trait Anxiety Inventory
    Time Frame
    1 year
    Title
    Depression
    Description
    Beck Depression Inventory
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective breast surgery due to breast cancer Voluntary BMI ≥ 18 and ≤ 35 kg/m2 ASA 1-3 No regular use of beta-blockers or during the last 72 hours No contraindications to beta-blockers Exclusion Criteria: Pregnancy or breast feeding AV-block, degree II or III Untreated cardiac insufficiency Sinus bradycardia, heart rate < 45 / min or symptoms Sick sinus syndrome Cardiogenic shock Severe peripheral vascular disorder Systolic blood pressure < 100 mmHg Long PQ-time, > 0,24 seconds Known hypersensitivity to beta-blockers or the ingredients of the drug

    12. IPD Sharing Statement

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    The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients

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