The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
31 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
82
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Extubation time (minutes)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Adverse Events During Anesthesia Emergence (per patient)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 (%)
Prazo: 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)
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Xuyu Zhang, M.D., Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de maio de 2026
Conclusão Primária (Real)
24 de agosto de 2026
Conclusão do estudo (Real)
31 de agosto de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
28 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB[2025]680
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All IPD that underlie results in a publication will be shared.
Prazo de Compartilhamento de IPD
Starting 6 months after publication.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .