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Effect of Esmolol on Pain Due to Rocuronium

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01824758
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
2
Duration (Months)
44.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Esmolol on Pain Due to Rocuronium Injection Pain
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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: Lidocaine
    Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).
    Other Names:
  • Aritmal, Jetmonal

    • Drug: rocuronium
    0.05 mg/kg rocuronium
    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)

    Outcome Measures

    Primary Outcome Measures

    1. The injection pain due to rocuronium [1 month]

      Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

    Secondary Outcome Measures

    1. Score on pain due to injection of rocuronium [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.

    Other Outcome Measures

    1. To assess patient satisfaction [1 Month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diskapi Teaching and Research Hospital Ankara Altindag Turkey

    Sponsors and Collaborators

    • Ankara Diskapi Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma Kavak Akelma, Specialist, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01824758
    Other Study ID Numbers:
    • ESM 0538
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Oct 4, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by Fatma Kavak Akelma, Specialist, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
    esmolol, injection pain, lidocaine, rocuronium
    Additional relevant MeSH terms:
    Lidocaine
    Rocuronium
    Esmolol

    Study Results

    No Results Posted as of Oct 4, 2019