Postoperative SleepNCT07740343
Remimazolam for Postoperative Sleep in Elderly Patients
A study testing Remimazolam and propofol in people with Postoperative Sleep, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Postoperative Sleep
- 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
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 28 Feb 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 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged between 65 and 80 years.
- Scheduled for elective laparoscopic radical resection of colorectal cancer.
- American Society of Anesthesiologists (ASA) physical status class II-III.
- Able to understand the study protocol and provide written informed consent.
Who cannot join
- Known allergy to any study medications.
- Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] score > 10).
- Regular use of sedatives, antipsychotics or hormonal drugs within the past month.
- Preoperative cognitive impairment, screened using the education-adjusted Mini-Mental State Examination (MMSE).
- Preoperative history of neurological or psychiatric disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety disorders.
- Severe preoperative comorbidities involving the cardiovascular, cerebrovascular, respiratory, hepatic or renal systems, as follows:New York Heart Association (NYHA) functional class IV; current or recent (within 2 months) congestive heart failure; myocardial infarction or coronary stent implantation within the preceding 3 months; Uncontrolled frequent ventricular premature beats (>5 beats per minute), couplets, triplets, paired ventricular arrhythmias, multifocal ventricular premature beats, or R-on-T phenomenon; Second-degree atrioventricular block (Mobitz II type), third-degree atrioventricular block or sick sinus syndrome without pacemaker implantation; Stroke or transient ischemic attack within the preceding 3 months; Severe hypertension (blood pressure ≥ 180/110 mmHg); Severe respiratory tract infection (including common cold), or maximal voluntary ventilation (MMV) < 30% of the predicted value; Severe hepatic dysfunction (Child-Pugh score > 9); Acute or chronic renal failure without renal replacement therapy: Acute kidney injury was defined as an absolute increase in serum creatinine ≥ 0.3 mg/dL (≥26.5 μmol/L) or a relative increase ≥ 50% from baseline, or urine output < 0.5 mL/(kg·h) for more than 6 consecutive hours. Chronic renal failure or uremia was defined as serum creatinine > 451 μmol/L and estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
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- Severe coagulation disorders.
- Refusal to participate in the trial.
- Anticipated postoperative admission to the intensive care unit (ICU).
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
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Zeqing Gao, 19279516862, kkkkrystal0214@163.com
About this study
Official title: Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial
Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Polysomnography (PSG), the gold standard for objective sleep assessment, has not been widely used to evaluate these effects in this population. Therefore, this study employs a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, thereby offering more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic colorectal cancer surgery.
Read the detailed description
Laparoscopic radical resection of colorectal cancer is the most commonly used surgical approach for colorectal cancer in elderly patients. Although this technique is less invasive than traditional open surgery, more than 60% of elderly patients still experience significant sleep fragmentation and disturbance in the early postoperative period, making effective sleep preservation a key component of enhanced recovery after surgery (ERAS).
Sedative agents play a critical role in modulating perioperative sleep patterns. Remimazolam, a novel ultra-short-acting benzodiazepine, is considered a promising anesthetic for elderly patients due to its favorable pharmacokinetic profile and minimal dependence on hepatic and renal function. However, its impact on objective sleep architecture remains unclear. Propofol, the most widely used sedative in general anesthesia, has been reported to disrupt sleep cycles in the postoperative period, with inconsistent effects on slow-wave sleep and rapid eye movement (REM) sleep.
Polysomnography (PSG) is the gold standard for assessing sleep architecture, including total sleep time, sleep efficiency, sleep stage distribution, and arousals. Previous studies have demonstrated that remimazolam is associated with improvements in subjective sleep outcomes in surgical patients. However, current research on remimazolam's effects on postoperative sleep after laparoscopic colorectal cancer surgery remains limited, particularly lacking high-quality, prospective, randomized controlled studies using objective PSG measurements to verify whether remimazolam can achieve superior sleep outcomes compared with propofol. Therefore, this study adopts a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, providing more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic radical resection of colorectal cancer.
- Conditions
- Postoperative Sleep
- Being tested
- Remimazolam, propofol
- Keywords
- postoperative sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
In the remimazolam group, anesthesia was induced with remimazolam 0.2 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. After 3 minutes of preoxygenation, tracheal intubation was performed, and mechanical ventilation was initiated to maintain PETCO₂ at 30-40 mmHg. Anesthesia was maintained with continuous infusions of remimazolam and remifentanil, guided by anesthetic depth monitoring. Rocuronium was supplemented intermittently and discontinued 30 minutes before the end of surgery.Polysomnography (PSG) was performed both preoperatively and postoperatively to measure total sleep time and sleep architecture. Subjective sleep quality was assessed using validated questionnaires during postoperative follow-up.
propofolDrug
In the propofol group, anesthesia was induced with propofol 1.0-1.5 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. Anesthesia was maintained with continuous infusions of propofol and remifentanil. All other procedural details were identical to those in the remimazolam group.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam (Group R) | Experimental | Remimazolam was used for both anesthesia induction and maintenance Receives: Drug: Remimazolam |
| Propofol (Group P) | Active comparator | Propofol was used for both anesthesia induction and maintenance. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST) on the first postoperative night
Polysomnography (PSG) was used to assess total sleep time on the first postoperative night in both groups.
Measured: On the first postoperative night
Secondary outcomes (13)
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Subjective sleep quality assessed via the Richards-Campbell Sleep Questionnaire (RCSQ), ranging from 0 to 100 points, with a higher score indicating better sleep quality. Result interpretation: A total score < 50 indicates poor sleep quality; 50 - 69 points indicate average sleep quality; ≥ 70 points indicate good sleep quality.
Measured: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 7
Pittsburgh Sleep Quality Index (PSQI) Score
Subjective sleep quality assessed via the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21; higher scores indicate worse sleep quality.
Measured: 1 month postoperatively
Resting Visual Analogue Scale (VAS) Pain Score
Pain at rest was measured in both groups preoperatively and at 1, 2, and 3 days postoperatively using the Visual Analogue Scale (VAS). Scores range from 0 to 10; higher scores indicate greater pain intensity.
Measured: at 1, 2, and 3 days postoperatively
The incidence of postoperative delirium
The incidence of postoperative delirium was evaluated in both groups at 1, 2, and 3 days postoperatively using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM).
Measured: at 1, 2, and 3 days postoperatively
Postoperative cognitive function
Cognitive function was assessed preoperatively, at 7 days postoperatively, and at 1 month postoperatively using the Mini-Mental State Examination (MMSE). Scores range from 0 to 30; higher scores indicate better cognitive function.
Measured: at 7 days postoperatively and at 1 month postoperatively
Sleep efficiency assessed by polysomnography (PSG)
Sleep efficiency measured by polysomnography (PSG). It is defined as the percentage of sleep time relative to total time spent in bed.
Measured: Postoperative Night 1
Number of awakenings after sleep onset assessed by polysomnography (PSG)
Number of awakenings after sleep onset measured by polysomnography (PSG).
Measured: Postoperative Night 1
Total wake time assessed by polysomnography (PSG)
Total duration of awakenings during sleep measured by polysomnography (PSG).
Measured: Postoperative Night 1
Proportion of each sleep stage assessed by polysomnography (PSG)
Proportion of each sleep stage measured by polysomnography (PSG), including N1,N2,N3 and REM.
Measured: Postoperative Night 1
Serum levels of cortisol
Serum levels of cortisol were measured preoperatively and on the morning of postoperative day 1 and compared between the two groups.
Measured: on the morning of postoperative day 1
Movement Visual Analogue Scale (VAS) Pain Score
Postoperative pain during movement assessed via the Visual Analogue Scale (VAS). Scores range from 0 to 10; higher scores indicate greater pain intensity.
Measured: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3
Serum C-reactive protein (CRP) level
Serum concentration of C-reactive protein (CRP).
Measured: Morning of postoperative day 1
Serum interleukin-6 (IL-6) level
Serum concentration of interleukin-6 (IL-6).
Measured: Morning of postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative SleepStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740343
- Sponsor's protocol ID
- RMZ on postoperative sleep
- Status last verified
- Sep 2026
- First submitted
- 31 May 2026
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam and Postoperative Sleep in Elderly Patients Undergoing Laparoscopic Colorectal Cancer Resection: A Randomized, Double-Blind, PSG-Based Controlled Trial
- ClinicalTrials.gov ID
- NCT07740343
- Acronym / sponsor ID
- RMZ on postoperative sleep
- Conditions
- Postoperative Sleep
- Keywords
- postoperative sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 31 Jul 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.
Postoperative sleep disturbance (PSD) is highly prevalent in elderly patients undergoing laparoscopic radical resection of colorectal cancer. Although remimazolam has shown favorable sedative properties and may alleviate perioperative stress, its effects on postoperative sleep architecture remain poorly understood. Polysomnography (PSG), the gold standard for objective sleep assessment, has not been widely used to evaluate these effects in this population. Therefore, this study employs a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, thereby offering more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic colorectal cancer surgery.
Detailed description
Laparoscopic radical resection of colorectal cancer is the most commonly used surgical approach for colorectal cancer in elderly patients. Although this technique is less invasive than traditional open surgery, more than 60% of elderly patients still experience significant sleep fragmentation and disturbance in the early postoperative period, making effective sleep preservation a key component of enhanced recovery after surgery (ERAS).
Sedative agents play a critical role in modulating perioperative sleep patterns. Remimazolam, a novel ultra-short-acting benzodiazepine, is considered a promising anesthetic for elderly patients due to its favorable pharmacokinetic profile and minimal dependence on hepatic and renal function. However, its impact on objective sleep architecture remains unclear. Propofol, the most widely used sedative in general anesthesia, has been reported to disrupt sleep cycles in the postoperative period, with inconsistent effects on slow-wave sleep and rapid eye movement (REM) sleep.
Polysomnography (PSG) is the gold standard for assessing sleep architecture, including total sleep time, sleep efficiency, sleep stage distribution, and arousals. Previous studies have demonstrated that remimazolam is associated with improvements in subjective sleep outcomes in surgical patients. However, current research on remimazolam's effects on postoperative sleep after laparoscopic colorectal cancer surgery remains limited, particularly lacking high-quality, prospective, randomized controlled studies using objective PSG measurements to verify whether remimazolam can achieve superior sleep outcomes compared with propofol. Therefore, this study adopts a randomized controlled trial design to verify whether remimazolam is superior to propofol in preserving postoperative sleep quality, providing more evidence-based options for anesthetic management in elderly patients undergoing laparoscopic radical resection of colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam (Group R) | Experimental | Drug: RemimazolamRemimazolam was used for both anesthesia induction and maintenance |
| Propofol (Group P) | Active comparator | Drug: propofolPropofol was used for both anesthesia induction and maintenance. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged between 65 and 80 years.
- Scheduled for elective laparoscopic radical resection of colorectal cancer.
- American Society of Anesthesiologists (ASA) physical status class II-III.
- Able to understand the study protocol and provide written informed consent.
Key exclusion criteria (9 listed)
- Known allergy to any study medications.
- Preoperative sleep disorder (Pittsburgh Sleep Quality Index [PSQI] score > 10).
- Regular use of sedatives, antipsychotics or hormonal drugs within the past month.
- Preoperative cognitive impairment, screened using the education-adjusted Mini-Mental State Examination (MMSE).
- Preoperative history of neurological or psychiatric disorders, including Alzheimer's disease, Parkinson's disease, depression and anxiety disorders.
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 |
|---|---|---|
| RemimazolamIn the remimazolam group, anesthesia was induced with remimazolam 0.2 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. After 3 minutes of preoxygenation, tracheal intubation was performed, and mechanical ventilation was initiated to maintain PETCO₂ at 30-40 mmHg. Anesthesia was maintained with continuous infusions of remimazolam and remifentanil, guided by anesthetic depth monitoring. Rocuronium was supplemented intermittently and discontinued 30 minutes before the end of surgery.Polysomnography (PSG) was performed both preoperatively and postoperatively to measure total sleep time and sleep architecture. Subjective sleep quality was assessed using validated questionnaires during postoperative follow-up. | Drug | Remimazolam (Group R) |
| propofolIn the propofol group, anesthesia was induced with propofol 1.0-1.5 mg/kg, sufentanil 0.3-0.5 μg/kg, and rocuronium 0.6-0.8 mg/kg. Anesthesia was maintained with continuous infusions of propofol and remifentanil. All other procedural details were identical to those in the remimazolam group. | Drug | Propofol (Group P) |
Primary outcome
Total sleep time (TST) on the first postoperative night
Time frame: On the first postoperative night
Polysomnography (PSG) was used to assess total sleep time on the first postoperative night in both groups.
13 secondary outcomes
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Time frame: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3, Postoperative Day 7
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: 1 month postoperatively
Resting Visual Analogue Scale (VAS) Pain Score
Time frame: at 1, 2, and 3 days postoperatively
The incidence of postoperative delirium
Time frame: at 1, 2, and 3 days postoperatively
Postoperative cognitive function
Time frame: at 7 days postoperatively and at 1 month postoperatively
Sleep efficiency assessed by polysomnography (PSG)
Time frame: Postoperative Night 1
Number of awakenings after sleep onset assessed by polysomnography (PSG)
Time frame: Postoperative Night 1
Total wake time assessed by polysomnography (PSG)
Time frame: Postoperative Night 1
Proportion of each sleep stage assessed by polysomnography (PSG)
Time frame: Postoperative Night 1
Serum levels of cortisol
Time frame: on the morning of postoperative day 1
Movement Visual Analogue Scale (VAS) Pain Score
Time frame: Postoperative Day 1, Postoperative Day 2, Postoperative Day 3
Serum C-reactive protein (CRP) level
Time frame: Morning of postoperative day 1
Serum interleukin-6 (IL-6) level
Time frame: Morning of postoperative day 1
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 3 Sep 2026.
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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 Postoperative Sleep, run by General Hospital of Ningxia 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 4 inclusion and 9 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 3 Sep 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 Liqin Deng Deng (13909511651, dengliqin71@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (TST) on the first postoperative night (time frame: On the first postoperative night). 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 3 Sep 2026.