Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Other: Placebo; Drug: Lidocaine

• Registration Number: NCT00840918
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

Detailed Description

Subjects undergoing cardiac surgery are randomized into one of two groups.

* Group 1: Intravenous Lidocaine Group

* Group 2: Intravenous placebo Group

Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.

Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2014-12-15
• Study Completion: 2014-12-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Age 18-90 years old
• Scheduled for cardiac surgery requiring cardiopulmonary bypass
• Written informed consent

Exclusion Criteria

• Off-pump surgical procedures
• Anticipated deep hypothermic circulatory arrest
• Any contraindications to the proposed interventions including lidocaine allergy
• History of preoperative atrial fibrillation
• Baseline Screening revealing preexisting dementia or delirium
• Preoperative liver failure defined as Child-Pugh Score > 6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
1	Lidocaine	Intravenous Lidocaine group

Primary Outcome Measures

Name	Time	Method
atrial fibrillation	postoperatively	To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of atrial fibrillation compared to an intravenous saline control.
mortality	30 days post surgery	To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of 30 day mortality as compared to an intravenous saline control.

Trial Locations

Locations (1)

SAL Hospital; 🇮🇳 Ahmedabad, Gujarat, India