- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05574257
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.
If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.
At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Jeollabukdo
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Iksan, Jeollabukdo, Corée, République de, 54538
- Wonkwag UH
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
- American Society of Anesthesiologists' physical status class (ASA) award class I-III.
Exclusion Criteria:
- Patients with fever before surgery
- Patients taking antipyretics before surgery
- Patients who are chronically using anti-inflammatory drugs
- High-risk patients with ASA class IV or higher
- Patient who refused sedation
- Patients with thyroid dysfunction.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group P
The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).
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Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Autres noms:
|
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Expérimental: Group R
The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).
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Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of perioperartive hypothermia
Délai: During surgery
|
Measure the body temperature on the tympanic membrane three times and enter the highest value.
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During surgery
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The incidence of perioperartive hypothermia
Délai: At PACU (Post Anesthesia Care Unit)
|
measure the body temperature three times on the tympanic membrane and enter the highest value.
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At PACU (Post Anesthesia Care Unit)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
core body temperature
Délai: Before the induction of anesthesia
|
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
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Before the induction of anesthesia
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core body temperature
Délai: During surgery
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Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
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During surgery
|
|
core body temperature
Délai: At PACU
|
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
|
At PACU
|
|
shivering grades
Délai: During surgery
|
|
During surgery
|
|
shivering grades
Délai: At PACU
|
|
At PACU
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Cheolhyeong Lee, M.D., Wonkwang University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WonkwangUH12
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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