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

14. februar 2013 oppdatert av: Sirilak Suksompong, Mahidol University

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

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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

32

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Ubonrajathani, Thailand, 34000
        • Charroonpong Choorat

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Normal saline IV
Normal saline IV
Andre navn:
  • NSS
Eksperimentell: 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.
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.
Andre navn:
  • magnesium

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Total 24 hour morphine requirement
Tidsramme: 24 hour
24 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2011

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

15. desember 2010

Først innsendt som oppfylte QC-kriteriene

15. desember 2010

Først lagt ut (Anslag)

16. desember 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. februar 2013

Sist bekreftet

1. februar 2013

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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