NCT01345981

Brief Summary

To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

April 25, 2011

Last Update Submit

April 29, 2011

Conditions

Adult Disease

Outcome Measures

Primary Outcomes (1)

  • pain on injection

    4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection

    30 minutes

Secondary Outcomes (1)

  • hemodynamic change

    30 minutes

Study Arms (3)

lidocaine 20 mg

EXPERIMENTAL

intravenous lidocaine

Drug: Lidocaine

lidocaine 40 mg

EXPERIMENTAL

intravenous lidocaine 40 mg

Drug: Lidocaine

normal saline

PLACEBO COMPARATOR

2 ml

Drug: Lidocaine

Interventions

LidocaineDRUG

dosage 20 mg and 40 mg

lidocaine 20 mglidocaine 40 mgnormal saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I - III patients
  • undergoing elective surgery
  • age 18-75 years

You may not qualify if:

  • allergy to propofol and lidocaine
  • abnormal liver and renal functions
  • has psychological problem or drug abuse
  • has recieved analgesic drug 2 weeks prior to surgery
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Disease

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 2, 2011

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

TH(1)