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Withdrawn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
About this trial
This is an interventional treatment trial for Breast Cancer
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
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
NCT ID
NCT02269696
First Posted
September 19, 2014
Last Updated
March 21, 2018
Sponsor
Kuopio University Hospital
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Withdrawn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Withdrawn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
Learn more about this trial
The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
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