Lidocaine Infusion for Major Abdominal Pediatric Surgery

NCT01387568 | Completed Phase 3 DMC

• 1 other identifier: MUH-AD-1-2011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.

Conditions

Elective Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  for 2hrs after infusion

Secondary Outcomes (4)

• Plasma Cortisol

  for 24 hrs after infusion

• Serum lidocaine

  6 hrs after infusion

• Heart rate (HR)

  for 6 hrs after infusion

• Pain scales

  24 hrs postoperative

Study Arms (2)

group L

ACTIVE COMPARATOR

Lidocaine group

Drug: Lidocaine Infusion

group P

PLACEBO COMPARATOR

Placebo group

Drug: saline Infusion

Interventions

Lidocaine Infusion DRUG

children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively

group L

saline Infusion DRUG

children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively

group P

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric
• Abdominal surgery
• ASA class I and II

You may not qualify if:

• history of hepatic diseases
• history of cardiac diseases
• history of renal diseases
• allergy to local anesthetics
• epilepsy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Anesthesia Dept, Mansoura University

Al Mansurah, DK, 050, Egypt

Location

Study Officials

• Alaa El Deep, MD

  alaaeldeep9@hotmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

EG (1)