Magnesium Infusion for Pain Relief After Thoracotomy. A Randomized Controlled Trial.

NCT01261702 | Terminated Phase 4

• 1 other identifier: 008/2552
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Magnesium Sulphate; Post Pulmonary Resection; Pain

Keywords

Magnesium sulphate; Post Pulmonary Resection; Pain

Outcome Measures

Primary Outcomes (1)

• Total 24 hour morphine requirement

  24 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline IV

Drug: Placebo

Magnesium sulphate

EXPERIMENTAL

Magnesium sulphate 50 mg/kg of magnesium sulphate infusion in 10 minutes before induction and then 15 mg/kg/hr until the end of the surgery.

Drug: magnesium sulphate

Interventions

Placebo DRUG

Normal saline IV

Also known as: NSS

Placebo

magnesium sulphate DRUG

The magnesium group (Group M, n=16) received 50 mg/kg of magnesium sulphate infusion in 10 minutes before induction and then 15 mg/kg/hr until the end of the surgery.

Also known as: magnesium

Magnesium sulphate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery
• Age 18-65 year
• ASA physical status 1-3
• Can use patient-controlled analgesia (PCA)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Charroonpong Choorat

Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Pain

Interventions

Magnesium Sulfate; Magnesium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Sirilak Suksompong, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

TH (1)