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

Phase 3

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: Metoprolol; Drug: Normal saline

• Registration Number: NCT02269696
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Status Verified: 2018-03
• Study Start: 2018-03-21
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-21
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoprolol	Metoprolol	Metoprolol infusion
Normal saline	Normal saline	Equal volume of saline.

Primary Outcome Measures

Name	Time	Method
Anaesthesia	Intraoperative	Total consumption of remifentanil
Postoperative pain	First 4 postoperative hours	Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
Long-term pain	1 year	The incidence and the level of pain at 12 months

Secondary Outcome Measures

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