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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02269696
• Other study ID #: KUH5101090
• Status: Withdrawn
• Phase: Phase 3
• First received: September 19, 2014
• Last updated: March 21, 2018
• Start date: March 21, 2018
• Est. completion date: March 21, 2018

Study information

• Verified date: March 2018
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Mastodynia

Intervention

Drug:
• Metoprolol
Intraoperative metoprolol infusion.
• Normal saline
Equal of volume compared to metoprolol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaesthesia	Total consumption of desflurane	Intraoperative
Primary	Anaesthesia	Total consumption of remifentanil	Intraoperative
Primary	Postoperative pain	Total analgesics consumption	First 4 postoperative hours
Primary	Postoperative pain	Time to analgesics	First 4 postoperative hours
Primary	Postoperative pain	Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement	First 4 postoperative hours
Primary	Long-term pain	The incidence and the level of pain at 3 months	3 months
Primary	Long-term pain	The incidence and the level of pain at 12 months	1 year
Secondary	Safety and tolerability	Number of patients with adverse effects	Perioperative
Secondary	Distribution to the central nervous system	Cerebro spinal fluid and blood samples	Perioperative
Secondary	Life satisfaction	Life satisfaction in a Likerts scale	1 year
Secondary	Anxiety	Spielberg State-Trait Anxiety Inventory	1 year
Secondary	Depression	Beck Depression Inventory	1 year