Effect of Esmolol on Pain Due to Rocuronium

NCT01824758 | Completed Phase 4 DMC

• 1 other identifier: ESM 0538
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site Irritation

Keywords

esmolol, injection pain, lidocaine, rocuronium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score on pain due to injection of rocuronium

  1 month

Other Outcomes (1)

• To assess patient satisfaction

  1 Month

Study Arms (3)

brevibloc (esmolol)

EXPERIMENTAL

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; Drug: rocuronium

Aritmal (Lidocaine)

ACTIVE COMPARATOR

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

Drug: Lidocaine; Drug: rocuronium

Placebo (NaCl 0.9%, 5 ml)

PLACEBO COMPARATOR

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

Drug: rocuronium; Drug: Placebo

Interventions

Lidocaine DRUG

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

Also known as: Aritmal, Jetmonal

Aritmal (Lidocaine)

Esmolol DRUG

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

Also known as: brevibloc

brevibloc (esmolol)

rocuronium DRUG

0.05 mg/kg rocuronium

Aritmal (Lidocaine); Placebo (NaCl 0.9%, 5 ml); brevibloc (esmolol)

Placebo DRUG

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

Placebo (NaCl 0.9%, 5 ml)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I and II patients
• Undergoing general anesthesia for elective surgery

You may not qualify if:

• Known allergy to esmolol or lidocaine
• Chronic pain
• Pregnancy
• Withdrawal of consent by the patient

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine; esmolol; Rocuronium

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fakelma 05327079113

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: April 5, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

TU (1)