General Anesthetic Drug Adverse ReactionREDNCT06180876
Effect of Remimazolam on Postoperative Delirium
A study testing remimazolam and propofol in people with General Anesthetic Drug Adverse Reaction, run by Zhihong LU at 1 site in China.
Trial summary
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- 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
- 262 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2022to 1 Jan 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- patients scheduled for elective surgery under general anesthesia
Who cannot join
- American Society of Anesthesiologists status ≥Ⅳ
- history of neurologic or psychiatric diseases
- difficulty in communication
- abuse of drug or alcohol
- suspected allergy to propofol or benzodiazepines
- significant cardiac, pulmonary, hepatic, or renal dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing hospital, Fourth military medical university
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- remimazolam, propofol
- Keywords
- general anesthesia, elderly patients, remimazolam, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolamDrug
continuous infusion
propofolDrug
continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| remimazolam | Experimental | Remimazolam (0.15 mg/kg) is used for anesthesia induction. Remimazolam continuous infusion is used for general anesthesia maintenance; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery Receives: Drug: remimazolam |
| propofol | Active comparator | Propofol (1.5 mg/kg) is used for anesthesia induction. Propofol continuous infusion is used for general anesthesia maintenance; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of delirium by 3 days after surgery
Measured: from end of surgery to 3 days after surgery, in a total of 3 days
Secondary outcomes (11)
incidence of delirium by 30 minutes after extubation (emergence delirium)
Measured: from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
incidence of delirium by 1 day after surgery
Measured: from end of surgery to 1 day after surgery, in a total of 1 day
time to eye opening
Measured: from end of surgery to open eye response to verbal command, in an average of 10 minutes
time to orientation
Measured: from end of surgery to being able to speak out name in an average of 10 minutes
incidence of hypotension during surgery
hypotension is defined as systolic blood pressure decreasing by more than 20% of baseline value
Measured: from start of anesthesia induction to extubation, in an average of 2 hours
dosage of vasoactive drugs during surgery
vasoactive drugs refer to norepinephrine and epinephrine
Measured: from start of anesthesia induction to extubation, in an average of 2 hours
Duration of sleep on the first night after surgery
sleep is monitored by a wrist acti-graphy
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
the visual analogue scale of sleep on the next day after surgery
0 is the worst quality of sleep, 10 is the best quality of sleep
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
the Athens Insomnia scale (AIS) of sleep on the next day after surgery
The AIS is a self-reported questionnaire designed to quantify sleep difficulty based on ICD-10 diagnostic criteria. It consists of 8 items rated on a 4-point scale (0 = no problem, 3 = severe problem), yielding a total score ranging from 0 to 24. A cutoff score of 6 provides optimal sensitivity and specificity for screening insomnia.
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
the time to onset of delirium
Measured: from end of surgery to onset of delirium, in an average of 1 days
the duration of delirium
the time between the first and last delirium-positive days
Measured: from onset of delirium to the last day of delirium, in an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start25 Jul 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for General Anesthetic Drug Adverse ReactionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180876
- Sponsor's protocol ID
- XJH-A-20220628
- Acronym
- RED
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tang F, Yi JM, Gong HY, Lu ZY, Chen J, Fang B, Chen C, Liu ZY. Remimazolam benzenesulfonate anesthesia effectiveness in cardiac surgery patients under general anesthesia. World J Clin Cases. 2021 Dec 6;9(34):10595-10603. doi: 10.12998/wjcc.v9.i34.10595.
PubMed 35004991Liu T, Lai T, Chen J, Lu Y, He F, Chen Y, Xie Y. Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double-blind, controlled trial. Pharmacol Res Perspect. 2021 Oct;9(5):e00851. doi: 10.1002/prp2.851.
PubMed 34390228Kilpatrick GJ. Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent. Front Pharmacol. 2021 Jul 20;12:690875. doi: 10.3389/fphar.2021.690875. eCollection 2021.
PubMed 34354587Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16.
PubMed 32417976Oka S, Satomi H, Sekino R, Taguchi K, Kajiwara M, Oi Y, Kobayashi R. Sedation outcomes for remimazolam, a new benzodiazepine. J Oral Sci. 2021 Jun 29;63(3):209-211. doi: 10.2334/josnusd.21-0051. Epub 2021 Jun 7.
PubMed 34092775
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of General Anesthesia With Remimazolam Versus Propofol on Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT06180876
- Acronym / sponsor ID
- RED / XJH-A-20220628
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- general anesthesia, elderly patients, remimazolam, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Dec 2023 (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.
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam | Experimental | Drug: remimazolamRemimazolam (0.15 mg/kg) is used for anesthesia induction. Remimazolam continuous infusion is used for general anesthesia maintenance; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery |
| propofol | Active comparator | Drug: propofolPropofol (1.5 mg/kg) is used for anesthesia induction. Propofol continuous infusion is used for general anesthesia maintenance; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥60 years
- patients scheduled for elective surgery under general anesthesia
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists status ≥Ⅳ
- history of neurologic or psychiatric diseases
- difficulty in communication
- abuse of drug or alcohol
- suspected allergy to propofol or benzodiazepines
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 |
|---|---|---|
| remimazolamcontinuous infusion | Drug | remimazolam |
| propofolcontinuous infusion | Drug | propofol |
Primary outcome
incidence of delirium by 3 days after surgery
Time frame: from end of surgery to 3 days after surgery, in a total of 3 days
11 secondary outcomes
incidence of delirium by 30 minutes after extubation (emergence delirium)
Time frame: from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes
incidence of delirium by 1 day after surgery
Time frame: from end of surgery to 1 day after surgery, in a total of 1 day
time to eye opening
Time frame: from end of surgery to open eye response to verbal command, in an average of 10 minutes
time to orientation
Time frame: from end of surgery to being able to speak out name in an average of 10 minutes
incidence of hypotension during surgery
Time frame: from start of anesthesia induction to extubation, in an average of 2 hours
dosage of vasoactive drugs during surgery
Time frame: from start of anesthesia induction to extubation, in an average of 2 hours
Duration of sleep on the first night after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
the visual analogue scale of sleep on the next day after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
the Athens Insomnia scale (AIS) of sleep on the next day after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
the time to onset of delirium
Time frame: from end of surgery to onset of delirium, in an average of 1 days
the duration of delirium
Time frame: from onset of delirium to the last day of delirium, in an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 35004991Tang F, Yi JM, Gong HY, Lu ZY, Chen J, Fang B, Chen C, Liu ZY. Remimazolam benzenesulfonate anesthesia effectiveness in cardiac surgery patients under general anesthesia. World J Clin Cases. 2021 Dec 6;9(34):10595-10603. doi: 10.12998/wjcc.v9.i34.10595.
- Background: PubMed 34390228Liu T, Lai T, Chen J, Lu Y, He F, Chen Y, Xie Y. Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double-blind, controlled trial. Pharmacol Res Perspect. 2021 Oct;9(5):e00851. doi: 10.1002/prp2.851.
- Background: PubMed 34354587Kilpatrick GJ. Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent. Front Pharmacol. 2021 Jul 20;12:690875. doi: 10.3389/fphar.2021.690875. eCollection 2021.
- Background: PubMed 32417976Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16.
- Background: PubMed 34092775Oka S, Satomi H, Sekino R, Taguchi K, Kajiwara M, Oi Y, Kobayashi R. Sedation outcomes for remimazolam, a new benzodiazepine. J Oral Sci. 2021 Jun 29;63(3):209-211. doi: 10.2334/josnusd.21-0051. Epub 2021 Jun 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthetic Drug Adverse Reaction, run by Zhihong LU 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 2 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: finished, as of the sponsor's last update on 12 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of delirium by 3 days after surgery (time frame: from end of surgery to 3 days after surgery, in a total of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06180876, which also lists 5 linked publications.
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 12 Aug 2026.