Esmolol Pretreatment on Pain During Injection of Propofol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. 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 propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo & propofol

Pretreatment with normal saline before injection of propofol

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

intravenous injection with normal saline before injection of propofol

propofol

Intervention Type DRUG

intravenous injection after pretreatment

esmolol 0.05 mg/kg & propofol

Pretreatment with esmolol 0.05 mg/kg before injection of propofol

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

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

propofol

Intervention Type DRUG

intravenous injection after pretreatment

esmolol 1 mg/kg & propofol

Pretreatment with esmolol 1 mg/kg before injection of propofol

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

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

propofol

Intervention Type DRUG

intravenous injection after pretreatment

remifentanil 0.35 ug/kg & propofol

Pretreatment with remifentanil 0.35 ug/kg before injection of propofol

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

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

propofol

Intervention Type DRUG

intravenous injection after pretreatment

Interventions

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Normal saline

intravenous injection with normal saline before injection of propofol

Intervention Type DRUG

Esmolol

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

Intervention Type DRUG

Remifentanil

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

Intervention Type DRUG

propofol

intravenous injection after pretreatment

Intervention Type DRUG

Other Intervention Names

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breviblock ultiva diprivan

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No