Cognitive deficit in first time CABG patients receiving Lidocaine versus procaine hydrochloride as an additive to the cardioplegia solution

Comparison of cardioplegic solutions which contain lidocaine or procaine hydrochloride in cognitive function after CABG surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201104224365N8

Enrollment

110

Registered

2011-06-28

Start date

2011-06-15

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Cognitive function after CABG surgery. Psychological and behavioural factors associated with disorders or diseases classified elsewhere

Interventions

Intervention 1: Intervention group receive lidocaine 2 mg/kg in cardioplegia solution. Intervention 2: Control group receive procaine hydrochloride 5 mg/kg in cardioplegia solution.

Treatment - Drugs

Intervention group receive lidocaine 2 mg/kg in cardioplegia solution

Control group receive procaine hydrochloride 5 mg/kg in cardioplegia solution

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Informed written consent; Elective CABG surgery; Age between 20 and 70 years; Use of the cardiopulmonary pump during surgery. Exclusion criteria: History of symptomatic cerebrovascular disease; Alcohol use (> 50 cc /day); History of psychiatric illness (any clinical diagnosis requiring therapy); History of drug abuse (any illicit drug abuse in the past 3 months); Hepatic insufficiency (liver function tests > 1.5 times of the normal upper limit); Sever pulmonary insufficiency (requiring home oxygen therapy); Renal failure (baseline serum creatinine > 2mg/dl); Lack of cooperation in response to cognitive test; together with other cardiac surgery (valvular surgery); History of previous cardiac surgery; Ejection fraction < 35%; history of sensitivity to lidocaine or procaine hydrochloride.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Cognitive function. Timepoint: The day before, 10 days and 2 month after operation. Method of measurement: Folstein Neurocognitive Test.	—

Secondary

Measure	Time frame
Cardiac Dysrrhythmia. Timepoint: Before trial, during the operation and three days later. Method of measurement: Cardiac monitoring.;Serum lidocaine level. Timepoint: 10 min before CPB, 10 and 60 min after CPB. Method of measurement: Laboratory kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Gholipour Baradari MD

Mazandaran University Of Medical Sciences

gholipourafshin@mazums.ac.ir; gholipourafshin@yahoo.com+98 15132612458

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026