Sleep DisturbanceNCT06108830
Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
A study testing Esketamine, Remimazolam and Esketamine and remimazolam in people with Sleep Disturbance, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Esketamine, Remimazolam and Esketamine and remimazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 10 Dec 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65 years old;
- ASA classification is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Who cannot join
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery;
- ASA rating of IV or V;
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
Show all 13Show fewer
- Respiratory insufficiency, respiratory failure;
- Patients who refused to use intravenous PCA for analgesia;
- Pregnant or lactating women;
- BMI<18 kg/m2 or BMI>30kg/m2;
- Poor compliance, unable to complete the experiment according to the study plan;
- Participants who have participated in clinical trials of other drugs within the last 4 weeks;
- Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Guolin Wang, +8618604755166
About this study
Official title: Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies
Read the detailed description
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration.Esketamine is an NMDA receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance and anxiety is worth exploring.
- Conditions
- Sleep Disturbance
- Being tested
- Esketamine, Remimazolam, Esketamine and remimazolam, normal saline
- Keywords
- Esketamine, remimazolam, anxiety, gastroenteroscopy
- Medical subject headings
- Parasomnias, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called Group of patients undergoing gastroenteroscopies with esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began
RemimazolamDrug
Also called Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Esketamine and remimazolamDrug
Also called Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
normal salineDrug
Also called Group of patients undergoing gastroenteroscopies with normal saline
Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began
| Study group | Role | What they receive |
|---|---|---|
| Group of patients undergoing gastroenteroscopies with normal saline | Placebo comparator | Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began Receives: Drug: normal saline |
| Group of patients undergoing gastroenteroscopies with esketamine | Active comparator | Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began Receives: Drug: Esketamine |
| Group of patients undergoing gastroenteroscopies with remimazolam | Active comparator | Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began Receives: Drug: Remimazolam |
| Group of patients undergoing gastroenteroscopies with remimazolam and esketamine | Active comparator | Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began Receives: Drug: Esketamine and remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbance and anxiety after surgery
Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.
Measured: 1 day before surgery, 1 and 3 days after surgery
Secondary outcomes (12)
Pain Score (NRS)
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Measured: 1 and 3 days after surgery
Incidence of injection pain
The frequency of injection pain induced by propofol was recorded
Measured: Intraoperative
Dosage of drug
The dosage of propofol, esketamine and remimazolam were recorded
Measured: Intraoperative
Mean intraoperative blood pressure
The mean intraoperative blood pressure was recorded
Measured: Intraoperative
Oxygen saturation
The mean intraoperative oxygen saturation was recorded
Measured: Intraoperative
Somatokinetic reaction
The number of intraoperative body movements was recorded
Measured: Intraoperative
Operation time
The duration of the patient's operation was recorded(up to 24 h)
Measured: Intraoperative
Duration of anesthesia
The patient's duration of anesthesia was recorded(up to 24 h)
Measured: After surgery
Time of awakening
The duration from the end of anesthesia to recovery was recorded(up to 24 h)
Measured: After surgery
Time to walking down
Record the time from waking up to walking down(up to 24 h)
Measured: After surgery
Adverse event
All kinds of adverse events occurred in patients were recorded
Measured: Within 3 days after surgery
Exhaust time
Records from end of anesthesia to patients with postoperative exhaust time for the first time
Measured: Within 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108830
- Sponsor's protocol ID
- GWang024
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
- ClinicalTrials.gov ID
- NCT06108830
- Acronym / sponsor ID
- GWang024
- Conditions
- Sleep Disturbance
- Keywords
- Esketamine, remimazolam, anxiety, gastroenteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 31 Oct 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.
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies
Detailed description
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration.Esketamine is an NMDA receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance and anxiety is worth exploring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group of patients undergoing gastroenteroscopies with normal saline | Placebo comparator | Drug: normal salinePatients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began |
| Group of patients undergoing gastroenteroscopies with esketamine | Active comparator | Drug: EsketaminePatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began |
| Group of patients undergoing gastroenteroscopies with remimazolam | Active comparator | Drug: RemimazolamPatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began |
| Group of patients undergoing gastroenteroscopies with remimazolam and esketamine | Active comparator | Drug: Esketamine and remimazolamPatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-65 years old;
- ASA classification is grade I-III;
- Elective surgery is proposed
- BMI of 19-30 kg/m2;
- Patients who agreed to enroll in this study voluntarily
Key exclusion criteria (13 listed)
- Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery;
- ASA rating of IV or V;
- Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
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 |
|---|---|---|
| EsketamineAlso: Group of patients undergoing gastroenteroscopies with esketaminePatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began | Drug | Group of patients undergoing gastroenteroscopies with esketamine |
| RemimazolamAlso: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure beganPatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began | Drug | Group of patients undergoing gastroenteroscopies with remimazolam |
| Esketamine and remimazolamAlso: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure beganPatients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began | Drug | Group of patients undergoing gastroenteroscopies with remimazolam and esketamine |
| normal salineAlso: Group of patients undergoing gastroenteroscopies with normal salinePatients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began | Drug | Group of patients undergoing gastroenteroscopies with normal saline |
Primary outcome
Sleep disturbance and anxiety after surgery
Time frame: 1 day before surgery, 1 and 3 days after surgery
Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.
12 secondary outcomes
Pain Score (NRS)
Time frame: 1 and 3 days after surgery
Incidence of injection pain
Time frame: Intraoperative
Dosage of drug
Time frame: Intraoperative
Mean intraoperative blood pressure
Time frame: Intraoperative
Oxygen saturation
Time frame: Intraoperative
Somatokinetic reaction
Time frame: Intraoperative
Operation time
Time frame: Intraoperative
Duration of anesthesia
Time frame: After surgery
Time of awakening
Time frame: After surgery
Time to walking down
Time frame: After surgery
Adverse event
Time frame: Within 3 days after surgery
Exhaust time
Time frame: Within 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- 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. This study is not recruiting at the moment.
Guolin Wang study director
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine, Remimazolam and Esketamine and remimazolam in people with Sleep Disturbance, run by Tianjin Medical University General Hospital 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 13 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 4 Sep 2024. 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. Some participants in this study may receive a placebo. 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 Guolin Wang, MD (+8615822855556, wangguolinghad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance and anxiety after surgery (time frame: 1 day before surgery, 1 and 3 days after surgery). 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 4 Sep 2024.