- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Jeollabukdo
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Iksan, Jeollabukdo, Korea, Republik von, 54538
- Wonkwag UH
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence of perioperartive hypothermia
Zeitfenster: During surgery
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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
Zeitfenster: At PACU (Post Anesthesia Care Unit)
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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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
core body temperature
Zeitfenster: Before the induction of anesthesia
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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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Before the induction of anesthesia
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core body temperature
Zeitfenster: 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
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core body temperature
Zeitfenster: At PACU
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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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At PACU
|
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shivering grades
Zeitfenster: During surgery
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During surgery
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shivering grades
Zeitfenster: At PACU
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At PACU
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Cheolhyeong Lee, M.D., Wonkwang University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- WonkwangUH12
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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