Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

NeuroTherapia, Inc.

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Drug: Lidocaine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00840918

08-861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Intravenous Lidocaine group

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Treatment:

Other: Placebo