- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07568405
The Effect of Remifentanil on the Objectively Measured Pressure Pain Threshold
L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement
It is a clinical study investigating the relationship between objectively measured pain threshold and the need for escalating doses of remifentanyl opioids. This study is expected to include approximately 40 participants.
The aim of the study is to objectively measure the analgesic effect of an increasing dose of opioids just before anesthesia.
Přehled studie
Postavení
Detailní popis
This is a prospective interventional study. Participants will undergo controlled pressure stimulation using an Algometer device to determine their pressure pain threshold (PPT).
Pressure pain threshold will be assessed at baseline (0 ng/mL) and during stepwise increasing target-controlled intravenous remifentanil concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.
Investigators hypothesize that increasing plasma concentrations of remifentanil will be associated with a corresponding increase in pressure pain threshold.
In addition, postoperative analgesic consumption will be recorded following surgery. This will allow the investigators to explore a potential association between intraoperative pressure pain threshold modulation and postoperative pain outcomes or analgesic requirements.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Brussels Capital
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Brussels, Brussels Capital, Belgie, 1070
- HUB Erasme
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adult patients who are able to volunteer
- ASA 1, 2and 3
Exclusion Criteria:
Refusal to participate;
- Body mass index (BMI) > 30 kg/m²;
- Allergy to any medication used for anesthesia;
- Chronic pain or regular use of analgesics;
- Severe ventricular dysfunction, pulmonary hypertension, or uncontrolled arrhythmia;
- Non-elective surgery;
- Participation in another study within the last 3 months;
- Pregnancy or breastfeeding;
- Severe renal or hepatic impairment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption
This is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored. Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions. Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented. |
Upon arrival in the operating room, the patient will undergo standard monitoring, including non-invasive blood pressure, electrocardiography (ECG), pulse oximetry (SpO₂), bispectral index (BIS™), and train-of-four (TOF) monitoring. An intravenous (IV) line will be placed, and crystalloid infusion will be initiated. Mechanical pain threshold will then be assessed using a Medoc algometer. Measurements will be performed on the dorsum of the non-dominant hand. Four measurements will be obtained at different target plasma concentrations of remifentanil(Ultiva®): 0, 1, 2, and 3 ng/mL. Remifentanil will be administered using a target-controlled infusion (TCI) system based on the Minto pharmacokinetic model. Following completion of these measurements, standardized intravenous anesthesia will be induced and maintained using propofol (propolipid®), remifentanil, and rocuronium (B.Braun®). Total perioperative consumption of remifentanil and propofol will be recorded. At the end of the surgical procedure, intravenous acetaminophen 1 g and a 4 mg morphine bolus will be administered. Upon arrival in the post-anesthesia care unit (PACU), pain will be assessed using the visual analogue scale (VAS). During the first 24 postoperative hours, analgesia will be provided via a patient-controlled analgesia (PCA) pump delivering 2 mg intravenous HCL morphine (Sterop®) boluses on demand. The PCA settings will follow a 2/10/20 regimen: 2 mg morphine per demand dose, a 10-minute lockout interval, and a maximum dose of 20 mg over 4 hours. The use of acetaminophen as adjunct analgesia is permitted; however, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), piritramide, and magnesium are prohibited. Pain scores (VAS) will be reassessed at 12 and 24 hours postoperatively. All adverse events (e.g., nausea, delirium) will be monitored and recorded during the 24-hour postoperative period. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Measurement of the variation in the pressure pain threshold
Časové okno: Measurement of the mechanical pressure pain threshold will be initiated upon the participant's arrival in the operating room. The procedure is expected to last approximately 10-15 minutes and will be followed by induction of anesthesia.
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Change in mechanical pain threshold measured objectively using an algometer (AlgoMed®) at increasing plasma concentrations of remifentanil (0, 1, 2, and 3 ng/mL) during the preoperative period. The pain threshold is defined as the pressure (in kilopascals) at which the patient first reports pain during a standardized mechanical stimulus. |
Measurement of the mechanical pressure pain threshold will be initiated upon the participant's arrival in the operating room. The procedure is expected to last approximately 10-15 minutes and will be followed by induction of anesthesia.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Correlation between preoperative pain threshold and total postoperative morphine consumption
Časové okno: From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.
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Correlation between preoperative pain threshold and total postoperative morphine consumption (particularly within the first 24 hours using patient-controlled analgesia). Postoperative pain scores assessed using standard pain scales in the post-anesthesia care unit. Intraoperative opioid (remifentanil) consumption in a standardized anesthesia setting. Post operative opioid (PCA, morphine) consumption recorded within the first 24H post surgery. |
From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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