Health TrialsbyHealthPanel

The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time

ConditionLaparoscopic Hepatectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuyu Zhang

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1): Planned to undergo laparoscopic hepatectomy.

Disqualifiers

1）: Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    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.

  • propofol

    Drug

    Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: RemimazolamExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Extubation time (minutes)

The time (in minutes) from stopping intravenous sedative infusion to tracheal extubation.

Time frame
From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.

Secondary outcomes

1

Incidence of Adverse Events During Anesthesia Emergence (per patient)

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.

Time frame
From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.
2

PACU Length of Stay (minutes)

The time (in minutes) from PACU admission to PACU discharge.

Time frame
From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
3

Postoperative Hospital Stay (days)

The time (in days) from the end of surgery to hospital discharge.

Time frame
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
4

Incidence of Postoperative Complications (per patient)

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.

Time frame
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuyu Zhang

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov
Apply now