Perioperative Management of Patients With Pacemakers

Not Applicable

• Conditions: Preoperative State; Presence of Pacemaker
• Interventions: Device: Case management

• Registration Number: NCT03556241
• Lead Sponsor: Yong Seog Oh

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2017-04-24
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-03
• Last Update Submitted: 2018-06-03
• Study First Posted: 2018-06-14
• Last Update Posted: 2018-06-14
• Primary Completion: 2019-02
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: No change group	Case management	Case management consists keeping patient's current pacemaker mode during surgery

Primary Outcome Measures

Name	Time	Method
Occurrence of asystole	Perioperative period

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Seo Ch-gu, Korea, Republic of