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

NCT ID: NCT02269696

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2018-03-21

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metoprolol

Metoprolol infusion

Group Type: EXPERIMENTAL

Metoprolol

Intervention Type: DRUG

Intraoperative metoprolol infusion.

Normal saline

Equal volume of saline.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Equal of volume compared to metoprolol.

Interventions

Metoprolol

Intraoperative metoprolol infusion.

Intervention Type: DRUG

Normal saline

Equal of volume compared to metoprolol.

Intervention Type: DRUG

Other Intervention Names

Seloken; NaCl 0,9%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lasse Harkanen

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KUH5101090

Identifier Type: -

Identifier Source: org_study_id