Respiratory DepressionPhase 4NCT06816173
Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression
A Phase 4 study testing Propofol group and Remimazolam group in people with Respiratory Depression, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Propofol group and Remimazolam group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Feb 2026
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3-6 years, gender unrestricted;
- American Society of Anesthesiologists (ASA) physical status classification of I-II;
- Body Mass Index (BMI) between 14 kg/m² and 25 kg/m²;
- Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;
- The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.
Who cannot join
- Children requiring special care or under the supervision of a court or social welfare agency;
- Children who have received general anesthesia within 3 months prior to the screening period;
- Children with a history of respiratory diseases within the past 2 weeks or those deemed to have difficult airway management: Modified Mallampati score of III or IV;
- Children with severe cardiovascular diseases or endocrine system abnormalities;
- Children with known psychiatric disorders or cognitive impairments;
- Children with abnormal liver function, ALT (alanine aminotransferase) and/or AST (aspartate aminotransferase) >1.5 times the upper limit of normal; children with total bilirubin exceeding the upper limit of normal; children with abnormal kidney function, creatinine and/or blood urea nitrogen higher than the upper limit of normal;
- Children known or suspected to be allergic to the study drug or benzodiazepines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: Effect of Propofol Versus Remimazolam Intravenous Anesthesia Combined With Regional or Caudal Block on Respiratory Depression in Young Children: A Randomized Controlled Clinical Study
General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.
Read the detailed description
Ninety-six children aged 3-6 years scheduled for surgery under general anesthesia were randomly divided into two groups. Initially, fentanyl was administered at a dose of 2-3 mcg/kg, and after 3 minutes, different test drugs were given according to the group assignment. In group P, propofol was administered intravenously at a dose of 2.0 mg/kg, while in group R, remimazolam was administered intravenously at a dose of 0.45-0.55 mg/kg. After achieving loss of consciousness (LoC, MOAA/S ≤ 1), a laryngeal mask was inserted, and spontaneous breathing was maintained. Subsequently, the test drugs were infused according to the group assignment, and both groups received a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. After connecting the micro-infusion pump, regional or caudal block was performed. Once the local anesthetic had taken full effect, the infusion of remifentanil was stopped, and surgery began. The test drugs were stopped approximately 5 minutes before the end of the surgery, and the laryngeal mask was removed when spontaneous breathing reached a tidal volume of ≥ 6 ml/kg and a frequency of ≥ 15 breaths per minute.
The following data were recorded: the time to loss of consciousness, the incidence of respiratory depression during anesthesia, the success rate of intravenous sedation, the incidence of postoperative agitation, recovery time, MOAA/S scores, and vital signs such as heart rate, blood pressure, and pulse oximetry.
- Conditions
- Respiratory Depression
- Being tested
- Propofol group, Remimazolam group
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupDrug
Induction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer propofol intravenously at a dose of 2.0 mg/kg.
Maintenance phase: Infuse propofol (4-12 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.
Remimazolam groupDrug
Induction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer remimazolam intravenously at a dose of 0.45-0.55 mg/kg.
Maintenance phase: Infuse remimazolam (1-3 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| group P（Propofol group） | Experimental | Patients were assigned to group P (Propofol group) using a computer-generated random number table Receives: Drug: Propofol group |
| group R (Remimazolaml group) | Experimental | Patients were assigned to group R (Remimazolaml group) using a computer-generated random number table Receives: Drug: Remimazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory depression during anesthesia
During the induction and maintenance of anesthesia, the occurrence of respiratory depression is defined by meeting at least one of the following criteria:
- Spontaneous respiratory rate (RR) less than 12 breaths/min for a duration of 1 minute, or peripheral oxygen saturation (SpO2) less than 92% for a duration of 10 seconds.
- Loss of spontaneous breathing.
Measured: During the induction and maintenance of anesthesia
Secondary outcomes (5)
Success rate of anesthesia induction and maintenance
Successful anesthesia induction is defined as achieving loss of consciousness (LoC) without the use of rescue sedation during the induction period. Successful anesthesia maintenance is defined as not requiring rescue sedation or interruption of the study drug during the maintenance period.
Measured: During the induction and maintenance of anesthesia
Time to Loss of Consciousness (LoC)
The time from the start of administration of the study drug to the loss of consciousness in the subjects, defined as MOAA/S ≤ 1.
Measured: During anesthesia induction
PAED scores of the subjects in the PACU
The PAED scale consists of 5 items, which are: obeying commands and being communicative, purposeful behavior, attention to the surrounding environment, restlessness, and crying that cannot be comforted. A PAED score of ≥12 is defined as delirium.
Measured: Assess every 5 minutes after the child regains consciousness.
Recovery time
The time from the cessation of the study drug infusion during anesthesia maintenance to the recovery of the subject (defined as the first time when the MOAA/S score is continuously three times 5).
Measured: The moment of anesthesia recovery
Time-frequency characteristics of electroencephalogram (EEG)
The time-frequency characteristics of the frontal electroencephalogram (EEG) in children of different age groups under propofol or remimazolam general anesthesia (including induction, maintenance, and recovery phases).
Measured: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huacheng Liu, Principal investigator, Second Affiliated Hospital of Wenzhou Medical UniversityYuhang Cai, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816173
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-102
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol Versus Remimazolam Intravenous Anesthesia Combined With Regional or Caudal Block on Respiratory Depression in Young Children: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06816173
- Acronym / sponsor ID
- SAHoWMU-CR2025-03-102
- Conditions
- Respiratory Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.
Detailed description
Ninety-six children aged 3-6 years scheduled for surgery under general anesthesia were randomly divided into two groups. Initially, fentanyl was administered at a dose of 2-3 mcg/kg, and after 3 minutes, different test drugs were given according to the group assignment. In group P, propofol was administered intravenously at a dose of 2.0 mg/kg, while in group R, remimazolam was administered intravenously at a dose of 0.45-0.55 mg/kg. After achieving loss of consciousness (LoC, MOAA/S ≤ 1), a laryngeal mask was inserted, and spontaneous breathing was maintained. Subsequently, the test drugs were infused according to the group assignment, and both groups received a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. After connecting the micro-infusion pump, regional or caudal block was performed. Once the local anesthetic had taken full effect, the infusion of remifentanil was stopped, and surgery began. The test drugs were stopped approximately 5 minutes before the end of the surgery, and the laryngeal mask was removed when spontaneous breathing reached a tidal volume of ≥ 6 ml/kg and a frequency of ≥ 15 breaths per minute.
The following data were recorded: the time to loss of consciousness, the incidence of respiratory depression during anesthesia, the success rate of intravenous sedation, the incidence of postoperative agitation, recovery time, MOAA/S scores, and vital signs such as heart rate, blood pressure, and pulse oximetry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group P（Propofol group） | Experimental | Drug: Propofol groupPatients were assigned to group P (Propofol group) using a computer-generated random number table |
| group R (Remimazolaml group) | Experimental | Drug: Remimazolam groupPatients were assigned to group R (Remimazolaml group) using a computer-generated random number table |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 3-6 years, gender unrestricted;
- American Society of Anesthesiologists (ASA) physical status classification of I-II;
- Body Mass Index (BMI) between 14 kg/m² and 25 kg/m²;
- Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;
- The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.
Key exclusion criteria (7 listed)
- Children requiring special care or under the supervision of a court or social welfare agency;
- Children who have received general anesthesia within 3 months prior to the screening period;
- Children with a history of respiratory diseases within the past 2 weeks or those deemed to have difficult airway management: Modified Mallampati score of III or IV;
- Children with severe cardiovascular diseases or endocrine system abnormalities;
- Children with known psychiatric disorders or cognitive impairments;
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 |
|---|---|---|
| Propofol groupInduction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer propofol intravenously at a dose of 2.0 mg/kg. Maintenance phase: Infuse propofol (4-12 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil. | Drug | group P（Propofol group） |
| Remimazolam groupInduction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer remimazolam intravenously at a dose of 0.45-0.55 mg/kg. Maintenance phase: Infuse remimazolam (1-3 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil. | Drug | group R (Remimazolaml group) |
Primary outcome
Incidence of respiratory depression during anesthesia
Time frame: During the induction and maintenance of anesthesia
During the induction and maintenance of anesthesia, the occurrence of respiratory depression is defined by meeting at least one of the following criteria: 1. Spontaneous respiratory rate (RR) less than 12 breaths/min for a duration of 1 minute, or peripheral oxygen saturation (SpO2) less than 92% for a duration of 10 seconds. 2. Loss of spontaneous breathing.
5 secondary outcomes
Success rate of anesthesia induction and maintenance
Time frame: During the induction and maintenance of anesthesia
Time to Loss of Consciousness (LoC)
Time frame: During anesthesia induction
PAED scores of the subjects in the PACU
Time frame: Assess every 5 minutes after the child regains consciousness.
Recovery time
Time frame: The moment of anesthesia recovery
Time-frequency characteristics of electroencephalogram (EEG)
Time frame: Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)
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 10 Feb 2025.
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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.
Huacheng Liu principal investigator
Second Affiliated Hospital of Wenzhou Medical University
Yuhang Cai principal investigator
Second Affiliated Hospital of Wenzhou Medical University
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 Propofol group and Remimazolam group in people with Respiratory Depression, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Feb 2025. 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 China. 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 Huacheng Liu (18957755138, huachengliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory depression during anesthesia (time frame: During the induction and maintenance of anesthesia). 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 10 Feb 2025.