Gastric CancerNCT07351474
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
A study testing Remimazolam and Propofol in people with Gastric Cancer and Postoperative Delirium, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Gastric Cancer, Postoperative Delirium
- What is being tested?
- Remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to 5 Jan 2027
- Phase
- Interventional
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Body mass index (BMI) between 18 and 28 kg/m².
- ASA physical status I-III.
- Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
- Able and willing to sign informed consent.
Who cannot join
- Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
- Stroke within the past 6 months or other central nervous system diseases.
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
- History of alcohol abuse or psychoactive substance dependence.
- Severe visual, hearing, or language impairment preventing communication.
- Allergy or contraindication to propofol or benzodiazepines.
- Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).
- Participation in another drug clinical trial within 1 month before surgery.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiongxiong Pan, +86 13813801858, xiongxiong@njmu.edu.cn
Siyang Li, +86 18745228706, hilary37727@163.com
About this study
Official title: Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.
Read the detailed description
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.
Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.
The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.
- Conditions
- Gastric Cancer, Postoperative Delirium
- Being tested
- Remimazolam, Propofol
- Keywords
- Remimazolam, Propofol, Elderly Patients, Laparoscopic Gastrectomy, Anesthesia, Postoperative Delirium
- Medical subject headings
- Stomach Neoplasms, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
PropofolDrug
Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group | Experimental | Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy. Receives: Drug: Remimazolam |
| Propofol Group | Active comparator | Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Postoperative Delirium
Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm.
Measured: From postoperative Day 1 to Day 3
Secondary outcomes (6)
Emergence Agitation
Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators.
Measured: Immediately after extubation until PACU discharge
Time to extubation
Time from discontinuation of anesthetic agents to successful tracheal extubation.
Measured: At the end of surgery
Postoperative Pain Score
Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10)
Measured: At PACU discharge; postoperative day 1,day 2,and day 3.
Post-induction Hypotension
Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to <65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction.
Measured: From completion of anesthetic induction to 10 minutes after induction.
Incidence of Postoperative Nausea and Vomiting
Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period.
Measured: From surgery until 48 hours postoperatively
Length of Hospital Stay(days)
Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system
Measured: From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start21 Jan 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongxiong Pan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351474
- Sponsor's protocol ID
- 2025-SR-1025
- Status last verified
- Nov 2026
- First submitted
- 14 Dec 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07351474
- Acronym / sponsor ID
- 2025-SR-1025
- Conditions
- Gastric Cancer, Postoperative Delirium
- Keywords
- Remimazolam, Propofol, Elderly Patients, Laparoscopic Gastrectomy, Anesthesia, Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 20 Jan 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.
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.
Detailed description
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.
Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.
The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.
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: RemimazolamParticipants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
| Propofol Group | Active comparator | Drug: PropofolParticipants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years.
- Body mass index (BMI) between 18 and 28 kg/m².
- ASA physical status I-III.
- Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
- Able and willing to sign informed consent.
Key exclusion criteria (8 listed)
- Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
- Stroke within the past 6 months or other central nervous system diseases.
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
- History of alcohol abuse or psychoactive substance dependence.
- Severe visual, hearing, or language impairment preventing communication.
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 |
|---|---|---|
| RemimazolamRemimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. | Drug | Remimazolam Group |
| PropofolPropofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60. | Drug | Propofol Group |
Primary outcome
incidence of Postoperative Delirium
Time frame: From postoperative Day 1 to Day 3
Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm.
6 secondary outcomes
Emergence Agitation
Time frame: Immediately after extubation until PACU discharge
Time to extubation
Time frame: At the end of surgery
Postoperative Pain Score
Time frame: At PACU discharge; postoperative day 1,day 2,and day 3.
Post-induction Hypotension
Time frame: From completion of anesthetic induction to 10 minutes after induction.
Incidence of Postoperative Nausea and Vomiting
Time frame: From surgery until 48 hours postoperatively
Length of Hospital Stay(days)
Time frame: From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)
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 4 Nov 2026.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
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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.
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 Gastric Cancer and Postoperative Delirium, run by The First Affiliated Hospital with Nanjing 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 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 4 Nov 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?
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 Xiongxiong Pan (+86 13813801858, xiongxiong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of Postoperative Delirium (time frame: From postoperative Day 1 to Day 3). 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 NCT07351474, which also lists 1 linked publication.
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 4 Nov 2026.