NCT01885364

Brief Summary

Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable pain

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

First Submitted

Initial submission to the registry

June 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

June 18, 2013

Last Update Submit

February 4, 2016

Conditions

Pain

Keywords

esmololpainpropofolremifentanil

Outcome Measures

Primary Outcomes (1)

  • Pain on injection of propofol

    Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).

    10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)

Study Arms (4)

Placebo & propofol

PLACEBO COMPARATOR

Pretreatment with normal saline before injection of propofol

Drug: Normal salineDrug: propofol

esmolol 0.05 mg/kg & propofol

EXPERIMENTAL

Pretreatment with esmolol 0.05 mg/kg before injection of propofol

Drug: EsmololDrug: propofol

esmolol 1 mg/kg & propofol

EXPERIMENTAL

Pretreatment with esmolol 1 mg/kg before injection of propofol

Drug: EsmololDrug: propofol

remifentanil 0.35 ug/kg & propofol

ACTIVE COMPARATOR

Pretreatment with remifentanil 0.35 ug/kg before injection of propofol

Drug: RemifentanilDrug: propofol

Interventions

Normal salineDRUG

intravenous injection with normal saline before injection of propofol

Placebo & propofol
EsmololDRUG

intravenous injection with remifentanil 0.5 mg/kg before injection of propofol

Also known as: breviblock
esmolol 0.05 mg/kg & propofolesmolol 1 mg/kg & propofol
RemifentanilDRUG

intravenous injection with remifentanil 0.35 ug/kg before injection of propofol

Also known as: ultiva
remifentanil 0.35 ug/kg & propofol
propofolDRUG

intravenous injection after pretreatment

Also known as: diprivan
Placebo & propofolesmolol 0.05 mg/kg & propofolesmolol 1 mg/kg & propofolremifentanil 0.35 ug/kg & propofol

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia

You may not qualify if:

  • Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Pain

Interventions

Saline SolutionesmololRemifentanilPropofol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Younghoon Jeon, Dr

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 25, 2013

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

KR(1)