Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversidade Federal de Sergipe

About this trial

The goal of this clinical trial is to compare two medicines used to induce general anesthesia in adults undergoing elective laparoscopic cholecystectomy. The study aims to determine whether remimazolam leads to a different time to loss of consciousness than propofol.

The main question it aims to answer is: Does remimazolam change the time to loss of consciousness compared with propofol during anesthesia induction?

Researchers will compare remimazolam with propofol to evaluate the time required for participants to lose consciousness. The study will also compare blood pressure, heart rate, and other safety outcomes during anesthesia induction.

Participants will:

* Be randomly assigned to receive either remimazolam or propofol for anesthesia induction. * Receive standard monitoring and anesthesia care throughout surgery. * Have their time to loss of consciousness, vital signs, and any adverse events recorded during the induction period.

Eligibility criteria

Qualifiers

Patients aged 18 years or older.

American Society of Anesthesiologists (ASA) physical status I or II.

Scheduled to undergo elective laparoscopic cholecystectomy under Total Intravenous Anesthesia (TIVA).

Disqualifiers

Patients younger than 18 years or older than 50 years

American Society of Anesthesiologists (ASA) physical status III to V

Body Mass Index (BMI) < 17.5 kg/m² or > 30 kg/m²

Hemodynamically unstable patients

Trial design

Treatments tested in this trial

  • Remimazolam
  • Propofol

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidade Federal de Sergipe

Lead sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Collaborator