Pain Clinical Trial
Official title:
Intravenous Magnesium Infusion for Pain Relief After Thoracotomy. A Randomized Controlled Trial.
Verified date | February 2013 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
All patients were premedicated with oral midazolam 5-15 mg. one hour before surgery. General anesthesia with double lumen endobronchial tube was given. Patient was induced by propofol and fentanyl. Cisatracurium was given to facilitate intubation. Patient was ventilated with 50% oxygen in air. Anesthesia was maintained with propofol and fentanyl in order to keep blood pressure and heart rate within 20% of the baseline. Cisatracurium was given every 30 minutes in order to control ventilation. At the end of surgery, neuromuscular blockade was reversed.In PACU, the I.V. PCA machine was connected to the patient. The setting of PCA was basal infusion of morphine 1 mg/hr bolus of morphine 1 mg with lockout interval 5 minutes and 4-hour limit 30 mg.The patient's mean arterial blood pressure, heart rate were recorded before induction, before intubation, at 15, 15, 30, 60, 90 and 120 minutes after intubation, and at 4, 8,16 and 24 h after surgery. The total amounts of fentanyl, propofol and magnesium sulphate were recorded. The time between the cessation of magnesium sulphate and extubation was recorded. The amounts of morphine usage at 4, 8, 16 and 24 hours after surgery were recorded. Pain score was evaluated at rest and deep breath and sedation score at 1, 2, 3, 4, 8, 16 and 24 hours after surgery using numeric rating scale (NRS). Sedation score was graded as 0 = fully awake, 1 = somnolence, responds to call, 2 = somnolence, responds to tactile stimulation, 3 = asleep, responds to painful stimulation. The times that the patient first sipping, taking food, sitting at the edge of bed and walk with help were also recorded. The side effects such as nausea, vomiting, pruritus and respiratory depression were recorded. Cost effective analysis was also evaluated.
Status | Terminated |
Enrollment | 32 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Elective surgery - Age 18-65 year - ASA physical status 1-3 - Can use patient-controlled analgesia (PCA) Exclusion Criteria: - History of allergy to magnesium sulphate - History of COPD, asthma or liver disease - Serum creatinine > 1.5 mg/dL - History of CHF or atrioventricular conduction disturbance - History of taking calcium channel blockers |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Charroonpong Choorat | Ubonrajathani |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total 24 hour morphine requirement | 24 hour | Yes |
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