- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00335972
The Effects of Dexmedetomidine and Remifentanil on Carotid Patients
Phase 4: The Effects of Dexmedetomidine and Remifentanil on Postoperative Hemodynamics and Pain/Opioids in Patients Undergoing Carotid Endarterectomy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Remifentanil is an amidopiperidine derivative with unique pharmacokinetic properties. Its steady-state volume of distribution is 30 L (3). Its context-sensitive half life is consistently short (3.2 min), even after prolonged infusion(4). The pharmacokinetic profile of remifentanil is independent of the hepatic (5) and renal function (6). And finally, the recovery profile of remifentanil is excellent with a speedy anesthetic emergence time which is important for a quick and proper neurologic assessment in the early postoperative period.
Remifentanil produces good intraoperative hemodynamic control during intense noxious stimulation like laryngoscopy, endotracheal intubation, and during pinning of the head (8). However, side effects of remifentanil include hypotension and bradycardia (15) intraoperatively, along with apnea(16,17) and hyperalgesia(18) postoperatively which is caused by increasing sensitivity to noxious stimuli. Investigations demonstrate different mechanisms of opioid-induced post-infusion anti-analgesia and secondary hyperalgesia (9). Overall remifentanil is a versatile opioid that is being increasingly used in the operating room.
DEXMEDETOMIDINE (DEX), an alpha-2 adrenoreceptor agonist, is gaining popularity in neuroanesthesia. It has a desirable neurophysiologic profile including neuroprotective characteristics through its effect on α2A receptor subtypes (10). Its hypnotic effect is mediated through the α2 receptors in the locus ceruleus and its analgesic properties are mediated through an effect on the dorsal horn of the spinal cord (11,12). Since it has sympatholytic and antinociceptive properties, it may improve hemodynamic stability at critical moments of neurosurgical stimulation. Dexmedetomidine reduces anesthetic drug and opioid requirements in the perioperative period (13,14). In addition, dexmedetomidine does not affect evoked potential monitoring, (19) making it a favorable anesthetic adjunct in cases in which neurophysiologic monitoring is being used. In recent years, dexmedetomidine has emerged as an effective drug useful in a wide range of anesthesia related areas.
Study Questions We postulate that dexmedetomidine provides better hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements.
Primary Hypothesis 1: Intraoperative dexmedetomidine provides better postoperative analgesia than remifentanil, thus reducing PACU opioid requirements.
Primary Hypothesis 2: Dexmedetomidine causes fewer hemodynamic perturbations than remifentanil.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Consenting adult patients (age >50 years) undergoing carotid endarterectomy with general anesthesia.
Exclusion Criteria:
- Receiving another alpha 2-adrenoreceptor agonist;
- Contraindication to dexmedetomidine, including allergy;
- Current hepatic disease (liver function tests > twice upper limit of normal);
- Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;
- Mentally impairment, including dementia or delirium;
- Heart block ;
- Sick sinus syndrome;
- Atrial fibrillation with a low ventricular response (< 50 bpm);
- Absolute or relative hypovolemia;
- Prior stroke;
- Severe left-ventricular dysfunction
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Remifentanil
Remifentanil will be infused throughout surgery at a rate of 0.1-0.2
µg/kg/min.
Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
|
Remifentanil will be infused throughout surgery at a rate of 0.1-0.2
µg/kg/min.
Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical
|
Aktiver Komparator: Dexmedetomidine
Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg).
The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate.
Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
|
Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg).
The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate.
Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mean Arterial Pressure
Zeitfenster: mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation
|
mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation
|
|
Visual Analogue Scale (VAS) Pain Score
Zeitfenster: pain score measured at 15, 30, 45, 60, and 90 minutes after extubation
|
Using a ruler, the score is determined by measuring the distance on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
0 = no pain and 10 = worst
|
pain score measured at 15, 30, 45, 60, and 90 minutes after extubation
|
Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery
Zeitfenster: During Post-anesthesia care unit after surgery,an average of 4 hours
|
intravenous morphine equivalents (mg)
|
During Post-anesthesia care unit after surgery,an average of 4 hours
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Arterielle Verschlusskrankheiten
- Erkrankungen der Halsschlagader
- Karotisstenose
- Physiologische Wirkungen von Arzneimitteln
- Adrenerge Wirkstoffe
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Analgetika, nicht narkotisch
- Adrenerge Alpha-2-Rezeptor-Agonisten
- Adrenerge Alpha-Agonisten
- Adrenerge Agonisten
- Analgetika, Opioide
- Betäubungsmittel
- Hypnotika und Beruhigungsmittel
- Remifentanil
- Dexmedetomidin
Andere Studien-ID-Nummern
- 10-27-05
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