Effect of Esmolol on Pain Due to Rocuronium

Overview

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.

Full Title of Study: “The Effect of Esmolol on Pain Due to Rocuronium Injection Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2013

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.

Interventions

  • Drug: Lidocaine
    • Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).
  • Drug: Esmolol
    • Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)
  • Drug: rocuronium
    • 0.05 mg/kg rocuronium
  • Drug: Placebo
    • Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)

Arms, Groups and Cohorts

  • 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)
  • 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)
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ankara Diskapi Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fatma Kavak Akelma, Specialist – Etlik Zubeyde Hanım Women’s Health Care, Training and Research Hospital
  • Overall Official(s)
    • Fakelma 05327079113, Principal Investigator, Diskapi Teaching and Research Hospital

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