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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Metoprolol
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoprolol<br>Metoprolol infusion | Drug: Metoprolol<br>* Intraoperative metoprolol infusion.<br>* Other names: Seloken;|
| Placebo Comparator: Normal saline<br>Equal volume of saline. | Drug: Normal saline<br>* Equal of volume compared to metoprolol.<br>* Other names: NaCl 0,9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaesthesia | Total consumption of desflurane | Intraoperative | 
| Anaesthesia | Total consumption of remifentanil | Intraoperative | 
| Postoperative pain | Total analgesics consumption | First 4 postoperative hours | 
| Postoperative pain | Time to analgesics | First 4 postoperative hours | 
| Postoperative pain | Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement | First 4 postoperative hours | 
| Long-term pain | The incidence and the level of pain at 3 months | 3 months | 
| Long-term pain | The incidence and the level of pain at 12 months | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Number of patients with adverse effects | Perioperative | 
| Distribution to the central nervous system | Cerebro spinal fluid and blood samples | Perioperative | 
| Life satisfaction | Life satisfaction in a Likerts scale | 1 year | 
| Anxiety | Spielberg State-Trait Anxiety Inventory | 1 year | 
| Depression | Beck Depression Inventory | 1 year |