General AnesthesiaNCT05533580
Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia
A study testing Remimazolam and Propofol in people with General Anesthesia and Laparoscopic Cholecystectomy, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years, gender not limited
- Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia, with an expected operative length of approximately 1h~2h
- Good penetration of the temporal window.
- ASA anesthesia classification grade I to II.
- can communicate effectively with the physician.
- Patients were aware of and voluntarily signed the informed consent form.
Who cannot join
- Relative contraindications to general anesthesia: patients with severe heart and lung function diseases.
- History of syncope, and dizziness.
- Patients with a history of psychiatric disorders, neurological disorders, drug abuse, or drug addiction
- Patients with cerebrovascular or carotid artery lesions;
- Those who are unable to cooperate in completing the test
- Persons who have taken benzodiazepines intermittently in the last three months.
- Those with known allergies or allergies to the test drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi
Fuzhou Hua, professor, +8615170238929, huafuzhou@126.com
About this study
Official title: Differential Effects of Remimazolam and Propofol on Dynamic Cerebral
Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to poor postoperative prognosis. As a novel ultra-short-acting benzodiazepines drugs, remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. Our study aimed to investigate the different effects of remimazolam and propofol on dynamic cerebral blood flow autoregulation function during general anesthesia.
- Conditions
- General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam, Propofol, Dynamic Cerebral Autoregulation
- Being tested
- Remimazolam, Propofol
- Keywords
- General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam, Propofol, dynamic cerebral autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called sufentanil, cisatracurium besylate
The experimental group was sedated with remimazolam.
PropofolDrug
Also called sufentanil, cisatracurium besylate
The control group was sedated with propofol.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | 1. Induction of anesthesia Slowly injects remimazolam 0.4-0.6 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional remimazolam (0.05 mg/kg each time) is allowed. After the LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.
2. Maintenance of anesthesia remimazolam 0.4~1.2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %. Receives: Drug: Remimazolam |
| Propofol group | Active comparator | 1. Induction of anesthesia Slowly injects propofol 2-4 mg/kg (about 1 min) until loss of consciousness (LoC), allowing additional propofol (0.5 mg/kg each time) if sedation is insufficient. after LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg. after sufficient muscle relaxation and blood circulation stabilization, the tracheal tube was inserted under the sliding scope.
2. Maintenance of anesthesia propofol 4~10mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in dynamic cerebral blood flow autoregulation
Comparison of the consistency, gain and phase of the transfer function parameters in the frequency range of 0.02-0.07 Hz, 0.07-0.2 Hz and 0.2-0.5 Hz for the propofol and rimazolam groups, respectively.
Measured: From the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.
Secondary outcomes (7)
systolic pressure
Indicators related to perioperative hemodynamics
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
diastolic pressure
Indicators related to perioperative hemodynamics
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
mean pressure
Indicators related to perioperative hemodynamics
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
heart rate
Indicators related to perioperative hemodynamics
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
pulse
Indicators related to perioperative hemodynamics
Measured: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
The period from discontinuation of anesthetic drugs to the recovery of the patient's self-consciousness and can respond correctly to external stimuli. All the patients can be allowed to leave the post-anesthesia care unit after Aldrete ≥ 9. Delayed awakening is defined as failure to achieve Aldrete ≥ 9 more than 30 minutes after surgery.
Measured: Up to 30 minutes after operation
Complication
All the perioperative complications are recorded.
Measured: During the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuzhou Hua, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533580
- Sponsor's protocol ID
- 2022-TCD-1
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Remimazolam and Propofol on Dynamic Cerebral
- ClinicalTrials.gov ID
- NCT05533580
- Acronym / sponsor ID
- 2022-TCD-1
- Conditions
- General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam, Propofol, Dynamic Cerebral Autoregulation
- Keywords
- General Anesthesia, Laparoscopic Cholecystectomy, Remimazolam, Propofol, dynamic cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 9 Sep 2022 (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.
Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to poor postoperative prognosis. As a novel ultra-short-acting benzodiazepines drugs, remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. Our study aimed to investigate the different effects of remimazolam and propofol on dynamic cerebral blood flow autoregulation function during general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam1. Induction of anesthesia Slowly injects remimazolam 0.4-0.6 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional remimazolam (0.05 mg/kg each time) is allowed. After the LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. 2. Maintenance of anesthesia remimazolam 0.4~1.2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %. |
| Propofol group | Active comparator | Drug: Propofol1. Induction of anesthesia Slowly injects propofol 2-4 mg/kg (about 1 min) until loss of consciousness (LoC), allowing additional propofol (0.5 mg/kg each time) if sedation is insufficient. after LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg. after sufficient muscle relaxation and blood circulation stabilization, the tracheal tube was inserted under the sliding scope. 2. Maintenance of anesthesia propofol 4~10mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years, gender not limited
- Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia, with an expected operative length of approximately 1h~2h
- Good penetration of the temporal window.
- ASA anesthesia classification grade I to II.
- can communicate effectively with the physician.
Key exclusion criteria (7 listed)
- Relative contraindications to general anesthesia: patients with severe heart and lung function diseases.
- History of syncope, and dizziness.
- Patients with a history of psychiatric disorders, neurological disorders, drug abuse, or drug addiction
- Patients with cerebrovascular or carotid artery lesions;
- Those who are unable to cooperate in completing the test
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 |
|---|---|---|
| RemimazolamAlso: sufentanil, cisatracurium besylateThe experimental group was sedated with remimazolam. | Drug | Remimazolam group |
| PropofolAlso: sufentanil, cisatracurium besylateThe control group was sedated with propofol. | Drug | Propofol group |
Primary outcome
Differences in dynamic cerebral blood flow autoregulation
Time frame: From the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.
Comparison of the consistency, gain and phase of the transfer function parameters in the frequency range of 0.02-0.07 Hz, 0.07-0.2 Hz and 0.2-0.5 Hz for the propofol and rimazolam groups, respectively.
7 secondary outcomes
systolic pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
diastolic pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
mean pressure
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
heart rate
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
pulse
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
Time frame: Up to 30 minutes after operation
Complication
Time frame: During the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with General Anesthesia and Laparoscopic Cholecystectomy, run by Second Affiliated Hospital of Nanchang 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 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuzhou Hua, professor (+8615170238929, huafuzhou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in dynamic cerebral blood flow autoregulation (time frame: From the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.). 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 29 Sep 2022.