Effect of Esmolol on Pain Due to Rocuronium

NCT ID: NCT01824758

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-05-31

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.

Conditions

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Injection Site Irritation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)

rocuronium

Intervention Type DRUG

0.05 mg/kg rocuronium

Aritmal (Lidocaine)

Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).

rocuronium

Intervention Type DRUG

0.05 mg/kg rocuronium

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)

Group Type PLACEBO_COMPARATOR

rocuronium

Intervention Type DRUG

0.05 mg/kg rocuronium

Placebo

Intervention Type DRUG

Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)

Interventions

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Lidocaine

Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).

Intervention Type DRUG

Esmolol

Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)

Intervention Type DRUG

rocuronium

0.05 mg/kg rocuronium

Intervention Type DRUG

Placebo

Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)

Intervention Type DRUG

Other Intervention Names

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Aritmal, Jetmonal brevibloc

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatma Kavak Akelma

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fakelma 05327079113

Role: PRINCIPAL_INVESTIGATOR

Diskapi Teaching and Research Hospital

Locations

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Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ESM 0538

Identifier Type: -

Identifier Source: org_study_id

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