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

Kuopio University Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Metoprolol; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02269696

KUH5101090

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Metoprolol

Experimental group

Description:

Metoprolol infusion

Treatment:

Drug: Metoprolol

Normal saline

Placebo Comparator group

Description:

Equal volume of saline.

Treatment:

Drug: Normal saline