Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

March 27, 2019 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 054
        • SAL Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Intravenous Lidocaine group
Drug: Lidocaine
Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
PLACEBO_COMPARATOR: Placebo
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Other: Placebo
Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atrial fibrillation
Time Frame: 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.
postoperatively
mortality
Time Frame: 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.
30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Martin Grady, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

December 15, 2014

Study Completion (ACTUAL)

December 15, 2014

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (ESTIMATE)

February 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-861

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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