Esmolol Pretreatment on Pain During Injection of Propofol

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Normal saline; Drug: Esmolol; Drug: Remifentanil; Drug: propofol

• Registration Number: NCT01885364
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-25
• Study Start: 2015-06
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo & propofol	Normal saline	Pretreatment with normal saline before injection of propofol
esmolol 0.05 mg/kg & propofol	Esmolol	Pretreatment with esmolol 0.05 mg/kg before injection of propofol
Placebo & propofol	propofol	Pretreatment with normal saline before injection of propofol
esmolol 0.05 mg/kg & propofol	propofol	Pretreatment with esmolol 0.05 mg/kg before injection of propofol
esmolol 1 mg/kg & propofol	propofol	Pretreatment with esmolol 1 mg/kg before injection of propofol
esmolol 1 mg/kg & propofol	Esmolol	Pretreatment with esmolol 1 mg/kg before injection of propofol
remifentanil 0.35 ug/kg & propofol	Remifentanil	Pretreatment with remifentanil 0.35 ug/kg before injection of propofol
remifentanil 0.35 ug/kg & propofol	propofol	Pretreatment with remifentanil 0.35 ug/kg before injection of propofol

Primary Outcome Measures

Name	Time	Method
Pain on injection of propofol	10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)	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).

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of