- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Jeollabukdo
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Iksan, Jeollabukdo, Korea, Republikken, 54538
- Wonkwag UH
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group P
The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).
|
Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Andre navne:
|
|
Eksperimentel: Group R
The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).
|
Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of perioperartive hypothermia
Tidsramme: 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
Tidsramme: At PACU (Post Anesthesia Care Unit)
|
measure the body temperature three times on the tympanic membrane and enter the highest value.
|
At PACU (Post Anesthesia Care Unit)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
core body temperature
Tidsramme: 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
Tidsramme: During surgery
|
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
Tidsramme: At PACU
|
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
|
At PACU
|
|
shivering grades
Tidsramme: During surgery
|
|
During surgery
|
|
shivering grades
Tidsramme: At PACU
|
|
At PACU
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Cheolhyeong Lee, M.D., Wonkwang University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- WonkwangUH12
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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