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- Klinische proef NCT01261702
Magnesium Infusion for Pain Relief After Thoracotomy. A Randomized Controlled Trial.
Intravenous Magnesium Infusion for Pain Relief After Thoracotomy. A Randomized Controlled Trial.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Ubonrajathani, Thailand, 34000
- Charroonpong Choorat
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Normal saline IV
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Normal saline IV
Andere namen:
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Experimenteel: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Total 24 hour morphine requirement
Tijdsspanne: 24 hour
|
24 hour
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Middelen tegen aritmie
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Anesthesie
- Membraantransportmodulatoren
- Anticonvulsiva
- Calciumregulerende hormonen en middelen
- Reproductieve controlemiddelen
- Calciumantagonisten
- Tocolytische middelen
- Magnesiumsulfaat
Andere studie-ID-nummers
- 008/2552
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