DexmedetomidinePhase 4SEEDSNCT05466708
Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients
A Phase 4 study testing Esketamine combined with dexmedetomidine and Dexmedetomidine in people with Dexmedetomidine and Ketamine, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A prospective, randomized controlled study was conducted to compare the effects of esketamine combined with dexmedetomidine in the sedation and analgesia treatment of mechanically ventilated patients in the ICU on the time to awaken, time to extubation, time to mechanical ventilation, time in the ICU, and on delirium. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dexmedetomidine, Ketamine, Analgesia
- What is being tested?
- Esketamine combined with dexmedetomidine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2022to 1 Dec 2024
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated with oral endotracheal intubation in the ICU;
- Patients aged >18 years and <70 years;
- Patients with expected mechanical ventilation time >24 hours.
Who cannot join
- Known or suspected allergy to esketamine, dexmedetomidine, remifentanil, or propofol;
- Pregnancy or lactation periods;
- Obesity defined as Body Mass Index >35kg/m2;
- Extreme hemodynamic or respiratory instability due to severe burn or trauma (defined as Injury Severity Score ≥25);
- Heavy drinking defined by WHO as drinking at least 60g of pure alcohol every day for men and at least 40g for women;
- Terminally ill patients near death, such as patients with extensively metastatic tumor or refractory shock;
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- Long-term exposure to sedatives, opioid analgesics or antianxiety drugs;
- Severe central nervous system disease such as cerebrovascular accidents, status epilepsy, or coma;
- Acute or chronic severe liver disease (Child-Pugh class C or history of liver transplant);
- Acute or chronic renal insufficiency needing dialysis;
- Patients or authorized surrogates refuse to provide informed consents;
- Mechanically ventilated for more than 24 hours prior to enrollment (not including the time on ventilators in the operation room).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 225500
Zuo Xiangrong, +86 13913979197, zuoxiangrong@njmu.edu.cn
About this study
Official title: Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study
A prospective, randomized controlled study was conducted to compare the effects of esketamine combined with dexmedetomidine in the sedation and analgesia treatment of mechanically ventilated patients in the ICU on the time to awaken, time to extubation, time to mechanical ventilation, time in the ICU, and on delirium.
Read the detailed description
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with rapid onset of action, easy to wake up, no accumulation in the body, little inhibition of respiration, sedative, hypnotic and anxiolytic effects, and also has a certain analgesic effect.Clinical studies have shown that the use of dexmedetomidine for sedation in ICU patients is beneficial in reducing the duration of mechanical ventilation and the incidence of delirium is low, but the sedative effect of dexmedetomidine is relatively weak, and has the side effects of slowing down heart rate and lowering blood pressure, so its clinical application is limited.Esketamine is an isomer of ketamine, its effect is stronger than ketamine, and glutamate N-methyl D-aspartate (NMDA) receptor binding, play a sedative, hypnotic, analgesic effect, rapid onset, strong effect, and small respiratory inhibition, bronchodilator effect, the disadvantage is that there is a vasoconstrictor effect can cause increased blood pressure, increased heart rate.
The combination of esketamine and dexmedetomidine can provide effective sedation and analgesia with the advantages of maintaining hemodynamic stability, maintaining stable spontaneous breathing and reducing psychiatric symptoms, and has been successfully used in clinical operations such as endoscopy, pediatric anesthesia and outpatient tooth extraction.
The effectiveness and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU has not been evaluated. In this study, a prospective, randomized, controlled, single-center study was conducted to evaluate the efficacy and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU.
- Being tested
- Esketamine combined with dexmedetomidine, Dexmedetomidine
- Keywords
- Dexmedetomidine, Esketamine, Analgesia, Sedation, Intensive Care Units, Mechanical Ventilation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine combined with dexmedetomidineDrug
Also called S-ketamine combined with dexmedetomidine
Esketamine, injection, 50mg/ bottle, source: hospital pharmacy, production unit: Jiangsu Hengrui Pharmaceutical Co., LTD., validity: 2 years, storage condition: airtight shading, room temperature.
Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride Injection
Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine combined with dexmedetomidine | Experimental | Esketamine will be administered at 1mg/kg, IVP, then intravenously pumped at 0.25-1.5mg/kg/h in combination with dexmedetomidine 1μg/kg for 20 min, followed by continuous intravenously pumped at 0.2-0.7mg/kg/h, maintaining a RASS score of -2-0. Receives: Drug: Esketamine combined with dexmedetomidine |
| Dexmedetomidine | Active comparator | Dexmedetomidine will be administered at 1μg/kg for 20 min, followed by continuous intravenous pumping at 0.2-0.7mg/kg/h to maintain a RASS score of -2-0 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Duration of mechanical ventilation after endotracheal intubation
Measured: Usually within 14 days
Secondary outcomes (7)
Time to extubation
Daily offline screening, SBT test if eligible, and extubation if SBT is successful
Measured: Usually within 14 days
Duration of ICU stay
Length of stay in ICU
Measured: Usually within 28 days
28-day mortality rate
Mortality of patients within 28 days from the time of tracheal intubation
Measured: Within 28 days
Recovery time
From the stop of sedatives to awakening
Measured: Within 14 days
Dose of Propofol
Total dose of rescue propofol
Measured: Within 14 days
Occurrence of delirium
The proportion of participants who have at least one positive CAM-ICU
Measured: Within 14 days
Adverse reactions
Adverse reactions that patients experience with the medication, such as hypertension, hypotension, rapid heart rate, slow heart rate
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start11 Aug 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (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 DexmedetomidineStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zuo Xiangrong, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466708
- Sponsor's protocol ID
- 2021120884Esketamine
- Acronym
- SEEDS
- Status last verified
- May 2024
- First submitted
- 12 Jul 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, You J, Hu J, Chen X, Wang H, Li N, Wei C, Tang W, Zuo X. Effect of esketamine combined with dexmedetomidine on delirium in sedation for mechanically ventilated ICU patients: protocol for a nested substudy within a randomized controlled trial. Trials. 2024 Jul 2;25(1):431. doi: 10.1186/s13063-024-08287-3.
PubMed 38956664
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study
- ClinicalTrials.gov ID
- NCT05466708
- Acronym / sponsor ID
- SEEDS / 2021120884Esketamine
- Keywords
- Dexmedetomidine, Esketamine, Analgesia, Sedation, Intensive Care Units, Mechanical Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Jul 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.
A prospective, randomized controlled study was conducted to compare the effects of esketamine combined with dexmedetomidine in the sedation and analgesia treatment of mechanically ventilated patients in the ICU on the time to awaken, time to extubation, time to mechanical ventilation, time in the ICU, and on delirium.
Detailed description
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with rapid onset of action, easy to wake up, no accumulation in the body, little inhibition of respiration, sedative, hypnotic and anxiolytic effects, and also has a certain analgesic effect.Clinical studies have shown that the use of dexmedetomidine for sedation in ICU patients is beneficial in reducing the duration of mechanical ventilation and the incidence of delirium is low, but the sedative effect of dexmedetomidine is relatively weak, and has the side effects of slowing down heart rate and lowering blood pressure, so its clinical application is limited.Esketamine is an isomer of ketamine, its effect is stronger than ketamine, and glutamate N-methyl D-aspartate (NMDA) receptor binding, play a sedative, hypnotic, analgesic effect, rapid onset, strong effect, and small respiratory inhibition, bronchodilator effect, the disadvantage is that there is a vasoconstrictor effect can cause increased blood pressure, increased heart rate.
The combination of esketamine and dexmedetomidine can provide effective sedation and analgesia with the advantages of maintaining hemodynamic stability, maintaining stable spontaneous breathing and reducing psychiatric symptoms, and has been successfully used in clinical operations such as endoscopy, pediatric anesthesia and outpatient tooth extraction.
The effectiveness and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU has not been evaluated. In this study, a prospective, randomized, controlled, single-center study was conducted to evaluate the efficacy and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine combined with dexmedetomidine | Experimental | Drug: Esketamine combined with dexmedetomidineEsketamine will be administered at 1mg/kg, IVP, then intravenously pumped at 0.25-1.5mg/kg/h in combination with dexmedetomidine 1μg/kg for 20 min, followed by continuous intravenously pumped at 0.2-0.7mg/kg/h, maintaining a RASS score of -2-0. |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine will be administered at 1μg/kg for 20 min, followed by continuous intravenous pumping at 0.2-0.7mg/kg/h to maintain a RASS score of -2-0 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanically ventilated with oral endotracheal intubation in the ICU;
- Patients aged >18 years and <70 years;
- Patients with expected mechanical ventilation time >24 hours.
Key exclusion criteria (12 listed)
- Known or suspected allergy to esketamine, dexmedetomidine, remifentanil, or propofol;
- Pregnancy or lactation periods;
- Obesity defined as Body Mass Index >35kg/m2;
- Extreme hemodynamic or respiratory instability due to severe burn or trauma (defined as Injury Severity Score ≥25);
- Heavy drinking defined by WHO as drinking at least 60g of pure alcohol every day for men and at least 40g for women;
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 |
|---|---|---|
| Esketamine combined with dexmedetomidineAlso: S-ketamine combined with dexmedetomidineEsketamine, injection, 50mg/ bottle, source: hospital pharmacy, production unit: Jiangsu Hengrui Pharmaceutical Co., LTD., validity: 2 years, storage condition: airtight shading, room temperature. Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature. | Drug | Esketamine combined with dexmedetomidine |
| DexmedetomidineAlso: Dexmedetomidine Hydrochloride InjectionDexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature. | Drug | Dexmedetomidine |
Primary outcome
Duration of mechanical ventilation
Time frame: Usually within 14 days
Duration of mechanical ventilation after endotracheal intubation
7 secondary outcomes
Time to extubation
Time frame: Usually within 14 days
Duration of ICU stay
Time frame: Usually within 28 days
28-day mortality rate
Time frame: Within 28 days
Recovery time
Time frame: Within 14 days
Dose of Propofol
Time frame: Within 14 days
Occurrence of delirium
Time frame: Within 14 days
Adverse reactions
Time frame: Within 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 38956664Zhang W, You J, Hu J, Chen X, Wang H, Li N, Wei C, Tang W, Zuo X. Effect of esketamine combined with dexmedetomidine on delirium in sedation for mechanically ventilated ICU patients: protocol for a nested substudy within a randomized controlled trial. Trials. 2024 Jul 2;25(1):431. doi: 10.1186/s13063-024-08287-3.
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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.
Zuo Xiangrong study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine combined with dexmedetomidine and Dexmedetomidine in people with Dexmedetomidine and Ketamine, 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 3 inclusion and 12 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 7 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zuo Xiangrong (+86 13913979197, zuoxiangrong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: Usually within 14 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 NCT05466708, 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 7 May 2024.