The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
31. august 2026 oppdatert av: Xuyu Zhang
The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial
This clinical trial aims to help us understand how two drugs, Propofol and Remazoloam, affect when researchers remove a Participants' breathing tube after liver surgery (laparoscopic liver resection).The main research questions include: comparing the time to breathing tube removal between patients who receive each drug, comparing changes in heart rate and blood pressure during surgery, and comparing the rates of unwanted medical events after surgery.
Researchers will give either Propofol or Remimazolam as a sedative medicine for anesthesia.
This will allow the researchers to compare the time to breathing tube removal after surgery.
Participants will complete their surgery according to a pre-planned surgical plan.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is a clinical randomized controlled trial aimed at comparing the postoperative extubation time of remimazolam versus propofol in patients undergoing laparoscopic liver resection.
Additionally, the study will compare intraoperative hemodynamic parameters, the incidence of adverse events during the anesthesia emergence period, length of stay in the post-anesthesia care unit (PACU), hospital length of stay, and the incidence of postoperative complications.
Patients meeting the inclusion criteria will sign informed consent forms and be randomly assigned to one of two groups.
Routine preoperative preparation will be performed.
After entering the operating room, anesthesia induction and maintenance will be carried out according to the study protocol.
After surgery, all patients will be transferred to the PACU.
Extubation will be performed when extubation criteria are met, and patients will be returned to the ward when the Steward recovery score reaches ≥4.
Data on postoperative extubation time, PACU stay, hospital length of stay, and postoperative complications will be recorded.
Finally, data analysis and results reporting will be conducted.This trial can provide meaningful references for clinical drug selection.
At the same time, this study will fill the gaps in clinical evidence in this field.
Studietype
Intervensjonell
Registrering (Faktiske)
82
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510000
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
1): Planned to undergo laparoscopic hepatectomy.
2): Has signed the informed consent form.
3): Aged 18 to 80 years.
4): Body Mass Index (BMI) ranging from 18 to 28 kg/m².
5): American Society of Anesthesiologists (ASA) physical status classification I to III.
Exclusion Criteria:
1）: Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.
2）: Diagnosis of neuropsychiatric disorders.
3）: Pregnant or lactating women.
4）: A history of allergy or contraindication to benzodiazepines, propofol, or any of their components.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Propofol
|
Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg.
Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.
|
|
Eksperimentell: Remimazolam
|
Anesthesia induction: Intravenous injection of remimazolam 0.2-0.4
mg/kg.
Anesthesia maintenance: Continuous infusion of remimazolam at 0.4-0.7mg/kg/h.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Extubation time (minutes)
Tidsramme: From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.
|
The time (in minutes) from stopping intravenous sedative infusion to tracheal extubation.
|
From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Adverse Events During Anesthesia Emergence (per patient)
Tidsramme: From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.
|
Incidence (per patient) of adverse events including nausea and vomiting, hypotension (MAP < 60 mmHg or MAP < 80% of baseline value), hypoxemia (SpO₂ < 90%), emergence agitation, dizziness, sore throat, hoarseness, shivering, occurring from cessation of continuous intravenous sedative infusion until PACU discharge.
|
From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.
|
|
PACU Length of Stay (minutes)
Tidsramme: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
|
The time (in minutes) from PACU admission to PACU discharge.
|
From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
|
|
Postoperative Hospital Stay (days)
Tidsramme: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
|
The time (in days) from the end of surgery to hospital discharge.
|
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
|
|
Incidence of Postoperative Complications (per patient)
Tidsramme: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
|
Incidence (per patient) of postoperative complications including pleural effusion, ascites (or peritoneal effusion), atelectasis, pulmonary embolism, kidney injury, wound infection, etc., occurring from the end of surgery to hospital discharge.
|
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
|
|
Mean Arterial Pressure (mmHg)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
Mean arterial pressure (MAP) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
|
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
|
Heart Rate (bpm)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
Heart rate (HR) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
|
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
|
Stroke Volume Variation (%)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
Stroke volume variation (SVV) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
|
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
|
Cardiac Index (L/min/m²)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
Cardiac index (CI) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
|
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Xuyu Zhang, M.D., Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. mai 2026
Primær fullføring (Faktiske)
24. august 2026
Studiet fullført (Faktiske)
31. august 2026
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
21. mai 2026
Først lagt ut (Faktiske)
28. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB[2025]680
Plan for individuelle deltakerdata (IPD)
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JA
IPD-planbeskrivelse
All IPD that underlie results in a publication will be shared.
IPD-delingstidsramme
Starting 6 months after publication.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
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