Effect of Esmolol on Pain Due to Rocuronium

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

Conditions
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Injection Site Irritation

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Esmolol
* Drug: rocuronium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brevibloc (esmolol)<br>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<br>* Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)<br>* Other names: brevibloc;Drug: rocuronium<br>* 0.05 mg/kg rocuronium<br>|
| Active Comparator: Aritmal (Lidocaine)<br>Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) | Drug: Lidocaine<br>* Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).<br>* Other names: Aritmal, Jetmonal;Drug: rocuronium<br>* 0.05 mg/kg rocuronium<br>|
| Placebo Comparator: Placebo (NaCl 0.9%, 5 ml)<br>Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) | Drug: rocuronium<br>* 0.05 mg/kg rocuronium<br>Drug: Placebo<br>* Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The injection pain due to rocuronium | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esmolol, injection pain, lidocaine, rocuronium