Effect of Esmolol on Pain Due to Rocuronium

Injection Site Irritation Clinical Trial

Official title:

The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824758
• Other study ID #: ESM 0538
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: October 2019
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Injection Site Irritation

Intervention

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

Locations

Country	Name	City	State
Turkey	Diskapi Teaching and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess patient satisfaction		1 Month
Primary	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	Score on pain due to injection 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.	1 month