Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00840918
• Other study ID #: 08-861
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: December 15, 2014

Study information

• Verified date: March 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: December 15, 2014
• Est. primary completion date: December 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Lidocaine
Intravenous Lidocaine Group - Lidocaine 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

Locations

Country	Name	City	State
India	SAL Hospital	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation	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
Primary	mortality	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