Effect of Esmolol on Pain Due to Rocuronium

Ankara Diskapi Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Injection Site Irritation

Treatments: Drug: Esmolol; Drug: rocuronium; Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01824758

ESM 0538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups, including a placebo group

brevibloc (esmolol)

Experimental group

Description:

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

Treatment:

Drug: Esmolol

Drug: rocuronium

Aritmal (Lidocaine)

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Drug: rocuronium

Placebo (NaCl 0.9%, 5 ml)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: rocuronium