NCT07717684 Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
| NCT ID | NCT07717684 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universidade Federal de Sergipe |
| Condition | Intravenous Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-08-21 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 66 participants in total. It began in 2026-08-21 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Patients aged 18 years or older. * American Society of Anesthesiologists (ASA) physical status I, II or III. * Scheduled to undergo elective laparoscopic cholecystectomy under Total Intravenous Anesthesia (TIVA). Exclusion Criteria: * Patients younger than 18 years or older than 60 years * American Society of Anesthesiologists (ASA) physical status IV to V * Body Mass Index (BMI) \< 17.5 kg/m² or \> 35 kg/m² * Hemodynamically unstable patients * Altered or impaired renal or hepatic function * Neuromuscular disorders * History of alcohol or drug dependence * History of allergy or hypersensitivity to any of the anesthetic medications utilized in the protocol
Contact & Investigator
Fabrício A Dias Antunes, MD, MSc, PhD
PRINCIPAL INVESTIGATOR
Universidade Federal de Sergipe
Frequently Asked Questions
Who can join the NCT07717684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Intravenous Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07717684 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07717684 currently recruiting?
Yes, NCT07717684 is actively recruiting participants. Contact the research team at gabrielfigueiredomascarenhas@gmail.com for enrollment information.
Where is the NCT07717684 trial being conducted?
This trial is being conducted at Aracaju, Brazil.
Who is sponsoring the NCT07717684 clinical trial?
NCT07717684 is sponsored by Universidade Federal de Sergipe. The principal investigator is Fabrício A Dias Antunes, MD, MSc, PhD at Universidade Federal de Sergipe. The trial plans to enroll 66 participants.