Esmolol Pretreatment on Pain During Injection of Propofol

Study Overview
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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.

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).

Official Title
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Esmolol Pretreatment on Pain During Injection of Propofol

Conditions
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Pain

Intervention / Treatment
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* Drug: Normal saline
* Drug: Esmolol
* Drug: Remifentanil
* Drug: propofol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo & propofol<br>Pretreatment with normal saline before injection of propofol | Drug: Normal saline<br>* intravenous injection with normal saline before injection of propofol<br>Drug: propofol<br>* intravenous injection after pretreatment<br>* Other names: diprivan;|
| Experimental: esmolol 0.05 mg/kg & propofol<br>Pretreatment with esmolol 0.05 mg/kg before injection of propofol | Drug: Esmolol<br>* intravenous injection with remifentanil 0.5 mg/kg before injection of propofol<br>* Other names: breviblock;Drug: propofol<br>* intravenous injection after pretreatment<br>* Other names: diprivan;|
| Experimental: esmolol 1 mg/kg & propofol<br>Pretreatment with esmolol 1 mg/kg before injection of propofol | Drug: Esmolol<br>* intravenous injection with remifentanil 0.5 mg/kg before injection of propofol<br>* Other names: breviblock;Drug: propofol<br>* intravenous injection after pretreatment<br>* Other names: diprivan;|
| Active Comparator: remifentanil 0.35 ug/kg & propofol<br>Pretreatment with remifentanil 0.35 ug/kg before injection of propofol | Drug: Remifentanil<br>* intravenous injection with remifentanil 0.35 ug/kg before injection of propofol<br>* Other names: ultiva;Drug: propofol<br>* intravenous injection after pretreatment<br>* Other names: diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esmolol, pain, propofol, remifentanil