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

NCT ID: NCT01261702

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-12-31

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.

Detailed Description

All patients were premedicated with oral midazolam 5-15 mg. one hour before surgery. In the operating room, each patient was monitored with noninvasive blood pressure, ECG and pulse oximetry. After the patient was anesthetized, direct blood pressure, end-tidal carbon dioxide tension (ETCO2) and esophageal temperature were monitored. Choice of anesthesia was general anesthesia with double lumen endobronchial tube (Bronchocath). Patient was induced by propofol 1.5-2.5 mg/kg and fentanyl 2 μg/kg. After the patient was unconscious, cisatracurium 0.2 mg/kg was given to facilitate intubation. Patient was ventilated with 50% oxygen in air. Anesthesia was maintained with propofol 6 -12 mg/kg/hr and 1 μg/kg of fentanyl was given intermittently every 1-1.5 hour in order to keep blood pressure and heart rate within 20% of the baseline. Cisatracurium (0.03 mg/kg) was given every 30 minutes in order to control ventilation. The patient was ventilated with volume controlled ventilator. Throughout the surgery, the ETCO2 was kept between 30-35 mmHg. During two lung ventilation, the airway pressure was kept within 20 cmH2O and respiratory rate 10-12 beats/minute. One lung ventilation was achieved with airway pressure less than 30 cmH2O and respiratory rate 12-20 beats/minute. During the surgery, the lower part of the patient was warmed with forced air warmer (Bier Hugger) At the end of surgery, neuromuscular blockade was reversed by prostigmine 2.5 mg and atropine 1.2 mg.

In the post anesthesia care unit, 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 hour 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Normal saline IV

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline IV

Magnesium sulphate

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.

Group Type: EXPERIMENTAL

magnesium sulphate

Intervention Type: 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.

Interventions

Placebo

Normal saline IV

Intervention Type: DRUG

magnesium sulphate

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.

Intervention Type: DRUG

Other Intervention Names

NSS; magnesium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Sirilak Suksompong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Charroonpong Choorat

Ubon Ratchathani, , Thailand

Countries

Thailand

Other Identifiers

008/2552

Identifier Type: -

Identifier Source: org_study_id