Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ülkü Özgül, Inonu University
ClinicalTrials.gov Identifier:
NCT01773044
First received: December 20, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.


Condition Intervention Phase
Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine
Drug: alkalinized lidocaine
Drug: Lidocaine
Drug: Placebo (for alcalinized lidocaine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Inonu University:

Primary Outcome Measures:
  • Pain on injection of propofol [ Time Frame: 5 th minutes after propofol injection ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: alkalinized lidocaine & lidocaine Drug: alkalinized lidocaine
recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
Drug: Lidocaine
0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
Active Comparator: alkalinized lidocaine &Placebo Drug: alkalinized lidocaine
recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
Drug: Placebo (for alcalinized lidocaine)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • undergoing elective surgery

Exclusion Criteria:

  • allergy to the study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773044

Locations
Turkey
Inonu university medicine faculty
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
  More Information

Publications:
Responsible Party: Ülkü Özgül, department of anesthesiology, Inonu University
ClinicalTrials.gov Identifier: NCT01773044     History of Changes
Other Study ID Numbers: ulkü_1
Study First Received: December 20, 2012
Last Updated: January 17, 2013
Health Authority: TURKEY: Ministry of Health Turkey Generate Directorate of Pharmaceuticals and Pharmacy

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014