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

Information source: Kuopio University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Metoprolol (Drug); Normal saline (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Kuopio University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Anaesthesia

Anaesthesia

Postoperative pain

Postoperative pain

Postoperative pain

Long-term pain

Long-term pain

Secondary outcome:

Safety and tolerability

Distribution to the central nervous system

Life satisfaction

Anxiety

Depression

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: October 2015
Last updated: June 12, 2015

Page last updated: August 23, 2015

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