Effect of Esmolol on Pain Due to Rocuronium

Phase 4

Completed

• Conditions: Injection Site Irritation
• Interventions: Drug: rocuronium; Drug: Esmolol; Drug: Lidocaine; Drug: Placebo

• Registration Number: NCT01824758
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-01
• Primary Completion: 2013-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Study Completion: 2013-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (NaCl 0.9%, 5 ml)	rocuronium	Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)
Placebo (NaCl 0.9%, 5 ml)	Placebo	Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)
brevibloc (esmolol)	rocuronium	Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)
brevibloc (esmolol)	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)
Aritmal (Lidocaine)	rocuronium	Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)
Aritmal (Lidocaine)	Lidocaine	Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Diskapi Teaching and Research Hospital; 🇹🇷 Ankara, Altindag, Turkey