Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00840918

Enrollment

123

Registered

2009-02-11

Start date

2009-02-28

Completion date

2014-12-15

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Cardiac surgery, Lidocaine, Quality of life

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.

Interventions

DRUGLidocaine

Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.

OTHERPlacebo

Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026