Effect of intravenous lidocaine in Bispectral index changes in cesarean section

Effect of intravenous lidocaine in Bispectral index changes in cesarean section under spinal anesthesia with bupivacain 0.5%

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201608063051N10

Enrollment

Registered

2016-10-09

Start date

2015-12-22

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

sedation in spinal anesthesia. Unspecified adverse effect of drug or medicament

Interventions

Intervention 1: In control group, we injected bolus dose of Normal Saline intravenously instead of Lidocaine.(in same volume of Lidocaine based on milliliter) 15 min before spinal anesthesia. then ma

Placebo

Treatment - Drugs

In control group, we injected bolus dose of Normal Saline intravenously instead of Lidocaine.(in same volume of Lidocaine based on milliliter) 15 min before spinal anesthesia. then maintenance dose o

In treatment group, 15 minutes before spinal anesthesia, 1.5 mg/kg of bolus Lidocaine 2% injected intravenously then, we infuse maintenance dose of IV Lidocaine 2%(1.5mg/kg/h) and Infusion of drug sho

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria :Elective cesarean surgery; patients aged 18 to 45 years, ASA class 1 and 2. Exclusion criteria: complete heart block; Sever bleeding and coagulation disorder; Sever hypotension and shock; septicemia; history of CNS disease; hyperthyroidism; hypertension; history of hepatorenal disease; Cardiovascular disease; diabetes; Allergy to lidocaine; placenta praevia; Placental abruption; cesarean induced deceleration Fetal heart rate (FHR); meconium; addict; contradiction of regional analgesia; eclampsia and preeclampsia; user of Beta blocker and glycoside.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Changes of Bispectral index. Timepoint: From the time of intervention; every 5 minute until 1 hour. Method of measurement: Monitoring devise (depth of anesthesia of 0 to 100).;Hemodynamic changes (Heart rate, Blood pressure and SPo2). Timepoint: From the time of intervention; every 5 minute until 15 minute then every 15 minute until 1 hour. Method of measurement: Monitoring devise.	—

Secondary

Measure	Time frame
The need for Ephedrine. Timepoint: During cesarean section. Method of measurement: Patient file.;Secondary effects (Headache ?nausea, itching? shivering). Timepoint: until 6 hours after surgery. Method of measurement: Questioner.;Apgar score. Timepoint: In the first and fifth minute from birth. Method of measurement: Apgar table.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Rajabi

Qazvin University of Medical Sciences

dr.108162@gmail.comvcrc92@yahoo.com+98 28 3323 6380

Outcome results

None listed

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