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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Metoprolol; Drug: Normal saline

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metoprolol; Metoprolol infusion	Drug: Metoprolol; Intraoperative metoprolol infusion.; Other Names: Seloken
Placebo Comparator: Normal saline; Equal volume of saline.	Drug: Normal saline; Equal of volume compared to metoprolol.; Other Names: NaCl 0,9%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 21, 2018
• Primary Completion (Anticipated): March 21, 2018
• Study Completion (Anticipated): March 21, 2018

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Mastodynia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: KUH5101090

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No