General AnesthesiaNCT05533567
Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol
A study testing Remimazolam and Propofol in people with General Anesthesia and Electroencephalography, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- General Anesthesia, Electroencephalography, Laparoscopic Cholecystectomy
- 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
- 12 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
- Right-handed, age 18-60 years, sex not limited.
- Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia in the morning, with an expected operative duration of approximately 1h to 2h.
- Body mass index (BMI) <28 kg/m2.
- Anxiety score >50, both without anxiety and sleep disorders.
- ASA anesthesia classification grade I with Mallampati class I airway anatomy.
- 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 cardiac or pulmonary function disease.
- Patients taking drugs that may confound EEG or behavioral findings or during pregnancy.
- Patients with a history of psychiatric or neurological disorders, drug abuse, or drug addiction.
- Any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc.;
- Inability to cooperate in completing the test, or refusal of the patient or family members to participate.
- 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
How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. 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. This study aimed to investigate the differences in the characteristics of EEG oscillations during general anesthesia by comparing propofol and remimazolam.
- Conditions
- General Anesthesia, Electroencephalography, Laparoscopic Cholecystectomy, Remimazolam, Propofol
- Being tested
- Remimazolam, Propofol
- Keywords
- Electroencephalography, General Anesthesia, Remimazolam, Propofol, Laparoscopic Cholecystectomy
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.
EEG waveforms
Contrasting differences in electroencephalographic oscillatory characteristics during general anesthesia with propofol and remimazolam.
Measured: Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.
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
- 12 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
- NCT05533567
- Sponsor's protocol ID
- 2022-EEG-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
- Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol
- ClinicalTrials.gov ID
- NCT05533567
- Acronym / sponsor ID
- 2022-EEG-1
- Conditions
- General Anesthesia, Electroencephalography, Laparoscopic Cholecystectomy, Remimazolam, Propofol
- Keywords
- Electroencephalography, General Anesthesia, Remimazolam, Propofol, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 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.
How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. 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. This study aimed to investigate the differences in the characteristics of EEG oscillations during general anesthesia by comparing propofol and remimazolam.
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 (7 listed)
- Right-handed, age 18-60 years, sex not limited.
- Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia in the morning, with an expected operative duration of approximately 1h to 2h.
- Body mass index (BMI) <28 kg/m2.
- Anxiety score >50, both without anxiety and sleep disorders.
- ASA anesthesia classification grade I with Mallampati class I airway anatomy.
Key exclusion criteria (6 listed)
- Relative contraindications to general anesthesia: patients with severe cardiac or pulmonary function disease.
- Patients taking drugs that may confound EEG or behavioral findings or during pregnancy.
- Patients with a history of psychiatric or neurological disorders, drug abuse, or drug addiction.
- Any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc.;
- Inability to cooperate in completing the test, or refusal of the patient or family members to participate.
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
EEG waveforms
Time frame: Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.
Contrasting differences in electroencephalographic oscillatory characteristics during general anesthesia with propofol and remimazolam.
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.
Related trials for General Anesthesia
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
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 Electroencephalography, 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 7 inclusion and 6 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?
EEG waveforms (time frame: Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.). 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.