Intravenous AnesthesiaPhase 4REMIPROP-LOCNCT07717684
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
A Phase 4 study testing Remimazolam and Propofol in people with Intravenous Anesthesia and Cholelithiasis, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Intravenous Anesthesia, Cholelithiasis
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Aug 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Univeritário da Universidade Federal de Sergipe
Aracaju, Sergipe
Grace D Anne Azevedo Doria, BPharm, MSc, PhD, +55 (79) 2105-1782, setgpi.huse@hubrasil.gov.br
About this study
Official title: Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled 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?
Read more
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.
Read the detailed description
General anesthesia can be induced with several intravenous hypnotic agents. Propofol remains a standard choice due to its rapid onset and predictable clinical effect; however, it is frequently associated with dose-dependent cardiovascular depression. Remimazolam, an ultra-short-acting benzodiazepine, represents an alternative with a distinct metabolic pathway via tissue esterases, potentially offering greater hemodynamic stability. Nonetheless, current literature comparing induction kinetics between these two pharmacological strategies exhibits high heterogeneity, often driven by variations in drug delivery methods and mixed surgical profiles.
To improve the internal validity of these clinical comparisons, this protocol restricts the evaluation to a single, specific surgical model. Narrowing the clinical environment to a uniform surgical procedure eliminates major confounding variables-such as widely divergent operational durations, patient positioning dynamics, unexpected blood loss, and varying baseline nociceptive stimuli-which typically complicate broader, multi-procedural anesthesia trials.
Furthermore, because the physical characteristics of the study medications preclude complete investigator masking during drug administration, specific operational safeguards are built into the clinical workflow. Anesthesia delivery during the induction phase relies entirely on pre-specified, automated delivery algorithms (comparing a fixed-rate continuous infusion against a pharmacokinetic target-controlled model) rather than subjective, clinician-guided titration. Utilizing fixed algorithmic delivery protocols prevents clinical preferences from influencing drug administration, thereby controlling for potential execution bias.
Following the induction phase, physiological tracking and depth-of-anesthesia monitoring are managed through objective, automated indices to ensure that post-induction adjustments remain standardized across both evaluation groups. This structured approach ensures that the resulting clinical observations reflect the distinct pharmacological and pharmacokinetic profiles of the selected hypnotic strategies rather than confounding clinical management choices.
- Conditions
- Intravenous Anesthesia, Cholelithiasis
- Being tested
- Remimazolam, Propofol
- Keywords
- Propofol, Remimazolam, General Anesthesia, Intravenous Anesthesia
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Lyophilized powder reconstituted for intravenous injection. Administered via an electronic infusion pump at a fixed continuous induction rate of 6 mg/kg/h until clinical benchmarks are achieved. Maintenance is sustained at a baseline continuous infusion rate of 1 mg/kg/h. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance remimazolam doses are precisely titrated based on real-time bispectral index (BIS) values to target a depth of anesthesia between 40 and 60.
PropofolDrug
Intravenous 1% lipid emulsion formulation of propofol. Administered via an automated target-controlled infusion (TCI) system programmed with the Marsh pharmacokinetic model. Induction is initiated at a fixed effect-site target concentration of 4 mcg/mL. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance propofol infusion rates are dynamically adjusted to maintain an objective bispectral index (BIS) within the 40-60 range.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Patients will receive intravenous remimazolam for both the induction and maintenance of general anesthesia. Anesthesia induction will be initiated via continuous intravenous infusion at a fixed rate of 6 mg/kg/h until loss of consciousness is achieved. Following induction, anesthesia maintenance will be transitioned to a continuous intravenous infusion of remimazolam at a baseline rate of 1 mg/kg/h, which will be titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure. Receives: Drug: Remimazolam |
| Propofol | Active comparator | Patients will receive intravenous propofol for both the induction and maintenance of general anesthesia. Anesthesia induction will be performed using a target-controlled infusion (TCI) model with a fixed target concentration of 4 mcg/mL until loss of consciousness is achieved. Following induction, anesthesia maintenance will be continued via propofol infusion, titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Loss of Consciousness (TLOC)
The duration, measured in seconds, from the exact initiation of the intravenous hypnotic agent infusion (either remimazolam or propofol) until the participant achieves clinical loss of consciousness. Loss of consciousness is strictly defined as the co-occurrence of two clinical criteria: the complete loss of response to a standardized verbal command (calling the patient's name aloud) and the absence of the eyelash/palpebral reflex (córneo-palpebral reflex), assessed continuously during the anesthesia induction phase.
Measured: From the initiation of the hypnotic agent infusion until the achievement of loss of consciousness (estimated time frame of up to 5 minutes during the anesthesia induction phase).
Secondary outcomes (7)
Incidence of Anesthesia-Induced Hypotension
Percentage of participants experiencing at least one episode of hypotension. Hypotension is operationally defined as a decrease in blood pressure of more than 20% from the participant's documented baseline value, or a mean arterial pressure (MAP) lower than 65 mmHg.
Measured: From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).
Incidence of Perioperative Adverse Events
Proportion of participants experiencing specific anesthesia-related adverse events, including bradycardia (heart rate < 50bpm), episodes of apnea within the Post-Anesthesia Care Unit (PACU), or any clinical event requiring unplanned therapeutic interventions.
Measured: From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)
Incidence of Early Postoperative Delirium
Percentage of participants with delirium at discharge from the Post-Anesthesia Care Unit (PACU), assessed using the 4AT (4 A's Test), a validated rapid screening tool for delirium.
Measured: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Bispectral Index (BIS) Values at Key Anesthetic Milestones
Objective tracking of depth of anesthesia using bispectral index (BIS) values (measured on a scale from 0 to 100, where 100 indicates fully awake and 0 indicates flat-line EEG). Continuous values will be extracted and compared at specific clinical time points: at the initiation of induction, during laryngoscopy, and periodically throughout the intraoperative period.
Measured: From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).
Time to Tracheal Extubation
The duration, measured in minutes, from the exact clinical cessation of the maintenance hypnotic delivery (propofol or remimazolam) and the remifentanil infusion until the safe and successful removal of the endotracheal tube.
Measured: From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).
Incidence of Postoperative Pain Requiring Opioid Rescue
Percentage of participants experiencing acute postoperative pain that necessitates the administration of supplemental opioid rescue analgesia as part of their recovery management.
Measured: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Incidence of Postoperative Nausea and Vomiting (PONV)
Percentage of participants experiencing episodes of nausea, vomiting, or retching during the immediate recovery phase.
Measured: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start21 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sergipe
- Sponsor type
- University, hospital or other
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Responsible party
- Principal investigator, Fabrício Dias Antunes, Universidade Federal de Sergipe
- Investigators
- Fabrício A Dias Antunes, MD, MSc, PhD, Principal investigator, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717684
- Sponsor's protocol ID
- 97389426.1.0000.5546
- Acronym
- REMIPROP-LOC
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the published results will be shared upon reasonable request after publication of the main findings. All shared data will be fully de-identified to protect participant privacy. Access will be granted to qualified researchers whose proposed use is methodologically sound and ethically appropriate. Data will be provided through a controlled process and only for research purposes aligned with the objectives of the study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07717684
- Acronym / sponsor ID
- REMIPROP-LOC / 97389426.1.0000.5546
- Conditions
- Intravenous Anesthesia, Cholelithiasis
- Keywords
- Propofol, Remimazolam, General Anesthesia, Intravenous Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General anesthesia can be induced with several intravenous hypnotic agents. Propofol remains a standard choice due to its rapid onset and predictable clinical effect; however, it is frequently associated with dose-dependent cardiovascular depression. Remimazolam, an ultra-short-acting benzodiazepine, represents an alternative with a distinct metabolic pathway via tissue esterases, potentially offering greater hemodynamic stability. Nonetheless, current literature comparing induction kinetics between these two pharmacological strategies exhibits high heterogeneity, often driven by variations in drug delivery methods and mixed surgical profiles.
To improve the internal validity of these clinical comparisons, this protocol restricts the evaluation to a single, specific surgical model. Narrowing the clinical environment to a uniform surgical procedure eliminates major confounding variables-such as widely divergent operational durations, patient positioning dynamics, unexpected blood loss, and varying baseline nociceptive stimuli-which typically complicate broader, multi-procedural anesthesia trials.
Furthermore, because the physical characteristics of the study medications preclude complete investigator masking during drug administration, specific operational safeguards are built into the clinical workflow. Anesthesia delivery during the induction phase relies entirely on pre-specified, automated delivery algorithms (comparing a fixed-rate continuous infusion against a pharmacokinetic target-controlled model) rather than subjective, clinician-guided titration. Utilizing fixed algorithmic delivery protocols prevents clinical preferences from influencing drug administration, thereby controlling for potential execution bias.
Following the induction phase, physiological tracking and depth-of-anesthesia monitoring are managed through objective, automated indices to ensure that post-induction adjustments remain standardized across both evaluation groups. This structured approach ensures that the resulting clinical observations reflect the distinct pharmacological and pharmacokinetic profiles of the selected hypnotic strategies rather than confounding clinical management choices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: RemimazolamPatients will receive intravenous remimazolam for both the induction and maintenance of general anesthesia. Anesthesia induction will be initiated via continuous intravenous infusion at a fixed rate of 6 mg/kg/h until loss of consciousness is achieved. Following induction, anesthesia maintenance will be transitioned to a continuous intravenous infusion of remimazolam at a baseline rate of 1 mg/kg/h, which will be titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure. |
| Propofol | Active comparator | Drug: PropofolPatients will receive intravenous propofol for both the induction and maintenance of general anesthesia. Anesthesia induction will be performed using a target-controlled infusion (TCI) model with a fixed target concentration of 4 mcg/mL until loss of consciousness is achieved. Following induction, anesthesia maintenance will be continued via propofol infusion, titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamLyophilized powder reconstituted for intravenous injection. Administered via an electronic infusion pump at a fixed continuous induction rate of 6 mg/kg/h until clinical benchmarks are achieved. Maintenance is sustained at a baseline continuous infusion rate of 1 mg/kg/h. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance remimazolam doses are precisely titrated based on real-time bispectral index (BIS) values to target a depth of anesthesia between 40 and 60. | Drug | Remimazolam |
| PropofolIntravenous 1% lipid emulsion formulation of propofol. Administered via an automated target-controlled infusion (TCI) system programmed with the Marsh pharmacokinetic model. Induction is initiated at a fixed effect-site target concentration of 4 mcg/mL. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance propofol infusion rates are dynamically adjusted to maintain an objective bispectral index (BIS) within the 40-60 range. | Drug | Propofol |
Primary outcome
Time to Loss of Consciousness (TLOC)
Time frame: From the initiation of the hypnotic agent infusion until the achievement of loss of consciousness (estimated time frame of up to 5 minutes during the anesthesia induction phase).
The duration, measured in seconds, from the exact initiation of the intravenous hypnotic agent infusion (either remimazolam or propofol) until the participant achieves clinical loss of consciousness. Loss of consciousness is strictly defined as the co-occurrence of two clinical criteria: the complete loss of response to a standardized verbal command (calling the patient's name aloud) and the absence of the eyelash/palpebral reflex (córneo-palpebral reflex), assessed continuously during the anesthesia induction phase.
7 secondary outcomes
Incidence of Anesthesia-Induced Hypotension
Time frame: From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).
Incidence of Perioperative Adverse Events
Time frame: From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)
Incidence of Early Postoperative Delirium
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Bispectral Index (BIS) Values at Key Anesthetic Milestones
Time frame: From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).
Time to Tracheal Extubation
Time frame: From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).
Incidence of Postoperative Pain Requiring Opioid Rescue
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the published results will be shared upon reasonable request after publication of the main findings. All shared data will be fully de-identified to protect participant privacy. Access will be granted to qualified researchers whose proposed use is methodologically sound and ethically appropriate. Data will be provided through a controlled process and only for research purposes aligned with the objectives of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrício A Dias Antunes, MD, MSc, PhD principal investigator
Universidade Federal de Sergipe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Propofol in people with Intravenous Anesthesia and Cholelithiasis, run by Universidade Federal de Sergipe at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel M Figueiredo Mascarenhas, MD (+5571987894554, gabrielfigueiredomascarenhas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Loss of Consciousness (TLOC) (time frame: From the initiation of the hypnotic agent infusion until the achievement of loss of consciousness (estimated time frame of up to 5 minutes during the anesthesia induction phase).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.