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Clinical Trials/NCT03556241
NCT03556241
Unknown
Not Applicable

Perioperative Management of Patients With Pacemakers

Yong Seog Oh1 site in 1 country300 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preoperative State
Sponsor
Yong Seog Oh
Enrollment
300
Locations
1
Primary Endpoint
Occurrence of asystole
Last Updated
7 years ago

Overview

Brief Summary

Traditionally, when a patient who received permanent pacemaker undergoes surgery, physicians change pacemaker mode to DDD and recommend to use bipolar electrocautery to minimize electromagnetic interference. However, pacemaker function is improving and there's diverse suggestions for such situations. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in case group and VOO is applied before surgery in control group. Perioperative adverse event would be compared in both groups.

Detailed Description

It has been more than 50 years after pacemaker device is developed. The subjects receiving permanent pacemaker has been increased and the number of patients with pacemaker undergoing surgery has been increased in company. However, in cases using electrocautery during surgery, there is possibility of malfunction of pacemaker due to electromagnetic interference. The factors associated with pacemaker malfunction during surgery have been reported; type of pacemaker, intrinsic heart rate, pacemaker dependency, type of electrocautery, position of generator, distance between generator/lead and electrocautery, duration and power of electrical energy. Conventionally, mode change to VOO before surgery and use of bipolar electrocautery are recommended before surgery but diverse suggestions regarding perioperative pacemaker mode change has been raised. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change by prospective randomized trial. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in the case group and VOO mode is applied before surgery in the control group. Exclusion criteria is thoracic surgery, 100% pacemaker dependency and unipolar pacing. The investigators will compare perioperative adverse events. The primary endpoint is asystole and the secondary endpoint is cardiac arrest, pacing inhibition, torsades de pointes and R on T.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
April 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yong Seog Oh
Responsible Party
Sponsor Investigator
Principal Investigator

Yong Seog Oh

professor

Seoul St. Mary's Hospital

Eligibility Criteria

Inclusion Criteria

  • over 19 years old Patients undergoing surgery using electrocautery who received permanent pacemaker

Exclusion Criteria

  • Thoracic surgery (lung, esophagus, heart, breast) Totally pacemaker dependent patient. Unipolar pacing

Outcomes

Primary Outcomes

Occurrence of asystole

Time Frame: Perioperative period

Study Sites (1)

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