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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02269696

Enrollment

Registered

2014-10-21

Start date

2018-03-21

Completion date

2018-03-21

Last updated

2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGMetoprolol

Intraoperative metoprolol infusion.

DRUGNormal saline

Equal of volume compared to metoprolol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Anaesthesia	Intraoperative	Total consumption of desflurane
Postoperative pain	First 4 postoperative hours	Total analgesics consumption
Long-term pain	3 months	The incidence and the level of pain at 3 months

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026