Effect of Esmolol on Pain Due to Rocuronium

October 2, 2019 updated by: Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital

The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey
        • Diskapi Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I and II patients
  • Undergoing general anesthesia for elective surgery

Exclusion Criteria:

  • Known allergy to esmolol or lidocaine
  • Chronic pain
  • Pregnancy
  • Withdrawal of consent by the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: brevibloc (esmolol)
Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)
Drug: Esmolol
Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)
Other Names:
  • brevibloc
Drug: rocuronium
0.05 mg/kg rocuronium
Active Comparator: Aritmal (Lidocaine)
Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)
Drug: rocuronium
0.05 mg/kg rocuronium
Drug: Lidocaine
Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).
Other Names:
  • Aritmal, Jetmonal
Placebo Comparator: Placebo (NaCl 0.9%, 5 ml)
Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)
Drug: rocuronium
0.05 mg/kg rocuronium
Drug: Placebo
Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The injection pain due to rocuronium
Time Frame: 1 month
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on pain due to injection of rocuronium
Time Frame: 1 month
Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.
1 month

Other Outcome Measures

Outcome Measure
Time Frame
To assess patient satisfaction
Time Frame: 1 Month
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Diskapi Training and Research Hospital

Investigators

  • Principal Investigator: Fakelma 05327079113, Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESM 0538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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