Injection Site Irritation Clinical Trial
Official title:
The Effect of Esmolol on Pain Due to Rocuronium Injection Pain
NCT number | NCT01824758 |
Other study ID # | ESM 0538 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | May 2013 |
Verified date | October 2019 |
Source | Ankara Diskapi Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Diskapi Teaching and Research Hospital | Ankara | Altindag |
Lead Sponsor | Collaborator |
---|---|
Ankara Diskapi Training and Research Hospital |
Turkey,
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 |
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