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Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block

23. august 2018 oppdatert av: Universiti Kebangsaan Malaysia Medical Centre

Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion

Orthopaedic surgeries involving the legs can be done under nerve block, where patients will be numb of pain at the operated site but awake during surgery. Sedation can be given to allay anxiety and provide comfort throughout the surgery. Sedation can be given by the anaesthetic doctors by using target-comtrolled infusion pump, or self-administered by patients by means of specialised machines. This study compares two method of administration of sedation, patient-controlled sedation (PCS) versus target-controlled infusion sedation (TCIS) by anaesthetic doctors, in people undergoing orthopaedic surgeries under nerve block.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various disciplines particularly orthopaedic surgeries. However the state of consciousness can potentially cause patient anxiety thus sedation is often utilized as a mean to improve patient satisfaction and increase patient acceptance of CNB.

Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the commonly used drug for sedation due to its favourable pharmacokinetic profile, which results in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by setting desired target plasma and effect site concentration. However it is difficult to judge precisely patient requirements for adequate patient sedation, comfort and analgesia as patients' needs differ.

Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery patient-controlled analgesia. It allows patients to titrate sedative medication to their comfort and therefore present an option that addresses the needs of patients with strong desire to maintain sense of control during procedures.

This study was designed to compare total propofol requirement between PCS versus TCI sedation (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic surgery under CNB.

Studietype

Intervensjonell

Registrering (Faktiske)

78

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Pusat Perubatan Universiti Kebangsaan Malaysia

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

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) I or II.
  2. Aged 18-65 years.
  3. Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours

Exclusion Criteria:

  1. Body Mass Index (BMI) > 30kg/m2
  2. Unable to cooperate (eg. mental disorders, language barrier)
  3. Drug abuse
  4. Alcoholism (chronic daily alcohol intake greater than 75 g of pure alcohol for ≥ 2 years, where 75g of alcohol = 5 cans of beer, 1 bottle of wine or half a pint of distilled spirit)
  5. Contraindications to the study drugs
  6. Pregnancy
  7. Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
  8. Features of difficult airway

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group PCS
Patients in Group PCS (patient-controlled sedation) received intravenous (IV) propofol via a patient controlled analgesia (PCA) infusion pump. The machine was set to deliver a demand bolus dose of 0.25 mg/kg with 1-minute lockout interval, without basal infusion.The patient was instructed to press on a hand-held device as often as required, to achieve their desired level of comfort or sedation.
Annen: patient-controlled sedation
Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
Aktiv komparator: Group TCIS
Patients in Group TCIS (target-controlled infusion sedation) received IV propofol via a target-controlled infusion (TCI) pump, targeted at an initial effect site concentration (Cet) of 0.6 μg/ml, using the Schnider pharmacokinetic model. Upon attainment of 0.6 μg/ml Cet, the patient's sedation level was assessed. The Cet was increased or reduced accordingly by 0.2 μg/ml to attain an OAA/S score of 3.
Annen: patient-controlled sedation
Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
total propofol requirement between PCS versus TCI sedation (TCIS)
Tidsramme: Assessed from the beginning to the end of sedation, at the average of 120 minutes
Total propofol requirement in both groups was calculated in mg/kg/hour.
Assessed from the beginning to the end of sedation, at the average of 120 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient satisfaction assessed by a 10-point numerical scale
Tidsramme: Within one hour after recovery from sedation
Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
Within one hour after recovery from sedation
Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
Tidsramme: Assessed from the beginning to the end of sedation, at the average of 120 minutes
Documented as Yes or No for each specified complication
Assessed from the beginning to the end of sedation, at the average of 120 minutes

Samarbeidspartnere og etterforskere

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

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Etterforskere

  • Hovedetterforsker: Nadia Md Nor, MMED(Anaes), Universiti Kebangsaan Malaysia Medical Centre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

22. juni 2017

Primær fullføring (Faktiske)

3. mai 2018

Studiet fullført (Faktiske)

3. mai 2018

Datoer for studieregistrering

Først innsendt

1. august 2018

Først innsendt som oppfylte QC-kriteriene

23. august 2018

Først lagt ut (Faktiske)

27. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • FF-2017-265

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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