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

NCT02269696 | Withdrawn Phase 3

• 1 other identifier: KUH5101090
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Safety and tolerability

  Perioperative

• Distribution to the central nervous system

  Perioperative

• Life satisfaction

  1 year

• Anxiety

  1 year

• Depression

  1 year

Study Arms (2)

Metoprolol

EXPERIMENTAL

Metoprolol infusion

Drug: Metoprolol

Normal saline

PLACEBO COMPARATOR

Equal volume of saline.

Drug: Normal saline

Interventions

Metoprolol DRUG

Intraoperative metoprolol infusion.

Also known as: Seloken

Metoprolol

Normal saline DRUG

Equal of volume compared to metoprolol.

Also known as: NaCl 0,9%

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metoprolol; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: October 21, 2014
• Study Start: March 21, 2018
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03