Cesarean DeliveryPhase 4NCT06613243

Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery

A Phase 4 study testing Esketamine 0.2 mg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg and Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg in people with Cesarean Delivery and Esketamine, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Cesarean Delivery, Esketamine, Neuropsychiatric Symptoms
What is being tested?: Esketamine 0.2 mg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg and Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 8 Oct 2024to 9 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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Pregnant women aged ≥18 years.
Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia.

Who cannot join

A previous history of schizophrenia;
Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher;
Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism;
Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
Other conditions that are considered unsuitable for study participation.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial

Esketamine is a commonly used analgesic during cesarean delivery, but may produce transient neuropsychiatric symptoms. Dexmedetomidine has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine can reduce esketamine related neuropsychiatric effects after general anesthesia. The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean section. This pilot trial is designed to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressive dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Read the detailed description

Esketamine is a commonly used anesthetic and analgesic drug during the perioperative period. Recent studies found that low-dose esketamine has rapid onset antidepressant effects and reduces postpartum depression when administered during cesarean delivery. However, even low-dose esketamine produces transient neuropsychiatric symptoms.

Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine reduces esketamine related neuropsychiatric adverse reactions in patients undergoing general anesthesia.

The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean delivery. The purpose of this pilot trial is to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressve dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Conditions: Cesarean Delivery, Esketamine, Neuropsychiatric Symptoms, Dexmedetomidine
Being tested: Esketamine 0.2 mg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg
Keywords: cesarean delivery, esketamine, neuropsychiatric symptoms, dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esketamine 0.2 mg/kgDrug
Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kgDrug
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kgDrug
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kgDrug
A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Study groups in NCT06613243
Study group	Role	What they receive
Esketamine 0.2 mg/kg	Active comparator	Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord. Receives: Drug: Esketamine 0.2 mg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg	Experimental	A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord. Receives: Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg	Experimental	A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord. Receives: Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg	Experimental	A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord. Receives: Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of dissociation within 24 hours.
Dissociative symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion. A CADSS score of >4 points at any timepoint indicates occurrence of dissociative symptoms.
Measured: Up to 24 hours after study drug infusion.

Secondary outcomes (4)

Severity of dissociative symptoms at different timepoints within 24 hours.
Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Measured: Up to 24 hours after study drug infusion.
Prevelance of dissociation at different timepoints within 24 hours.
Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Measured: Up to 24 hours after study drug infusion.
Incidence of neuropsychiatric adverse events within 24 hours.
Neuropsychiatric symptoms are evaluated with a structured checklist at 5-minute intervals during, at 10-minute intervals after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is recorded as presence of neuropsychiatric symptoms.
Measured: Up to 24 hours after study drug infusion.
Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.
Neuropsychiatric symptoms are evaluated with a structured checklist every 5 minutes during, every 10 minutes after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is defined as presence of neuropsychiatric symptoms.
Measured: Up to 24 hours after study drug infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20249 Dec 2024

First posted25 Sep 2024
Study start8 Oct 2024
Primary completion2 Dec 2024
Study completion9 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, double-blind, pilot trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06613243
Sponsor's protocol ID: 2024-468
Status last verified: Dec 2024
First submitted: 23 Sep 2024
Last updated: 30 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bremner JD, Krystal JH, Putnam FW, Southwick SM, Marmar C, Charney DS, Mazure CM. Measurement of dissociative states with the Clinician-Administered Dissociative States Scale (CADSS). J Trauma Stress. 1998 Jan;11(1):125-36. doi: 10.1023/A:1024465317902.
PubMed 9479681
Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.
PubMed 26063213
Daly EJ, Singh JB, Fedgchin M, Cooper K, Lim P, Shelton RC, Thase ME, Winokur A, Van Nueten L, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):139-148. doi: 10.1001/jamapsychiatry.2017.3739.
PubMed 29282469
Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
PubMed 29736744
Lu X, Tang L, Lan H, Li C, Lin H. A Comparison of Intranasal Dexmedetomidine, Esketamine or a Dexmedetomidine-Esketamine Combination for Induction of Anaesthesia in Children: A Randomized Controlled Double-Blind Trial. Front Pharmacol. 2022 Jan 27;12:808930. doi: 10.3389/fphar.2021.808930. eCollection 2021.
PubMed 35185548
Mello RP, Echegaray MVF, Jesus-Nunes AP, Leal GC, Magnavita GM, Vieira F, Caliman-Fontes AT, Telles M, Guerreiro-Costa LNF, Souza-Marques B, Bandeira ID, Santos-Lima C, Marback RF, Correia-Melo FS, Lacerda ALT, Quarantini LC. Trait dissociation as a predictor of induced dissociation by ketamine or esketamine in treatment-resistant depression: Secondary analysis from a randomized controlled trial. J Psychiatr Res. 2021 Jun;138:576-583. doi: 10.1016/j.jpsychires.2021.05.014. Epub 2021 May 8.
PubMed 33991996
Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
PubMed 37302963
Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
PubMed 38808490
Yang JR, Li YY, Ran TJ, Lin XY, Xu JY, Zhou SL, Huang PJ. Esketamine Combined with Dexmedetomidine to reduce Visceral Pain During elective Cesarean Section Under Combined Spinal-Epidural Anesthesia: A double-Blind Randomized Controlled Study. Drug Des Devel Ther. 2024 Jun 18;18:2381-2392. doi: 10.2147/DDDT.S460924. eCollection 2024.
PubMed 38911034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cesarean Delivery trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial
ClinicalTrials.gov ID: NCT06613243
Acronym / sponsor ID: 2024-468
Conditions: Cesarean Delivery, Esketamine, Neuropsychiatric Symptoms, Dexmedetomidine
Keywords: cesarean delivery, esketamine, neuropsychiatric symptoms, dexmedetomidine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Study start: 8 Oct 2024 (actual)
Primary completion: 2 Dec 2024 (actual)
Study completion: 9 Dec 2024 (actual)
First posted: 25 Sep 2024 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: A randomized, double-blind, pilot trial

Arm	Type	Receives
Esketamine 0.2 mg/kg	Active comparator	Drug: Esketamine 0.2 mg/kgEsketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg	Experimental	Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg	Experimental	Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg	Experimental	Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Pregnant women aged ≥18 years.
Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia.

Key exclusion criteria (5 listed)

A previous history of schizophrenia;
Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher;
Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism;
Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
Other conditions that are considered unsuitable for study participation.

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 0.2 mg/kgEsketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.	Drug	Esketamine 0.2 mg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.	Drug	Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.	Drug	Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg
Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kgA mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.	Drug	Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg

Primary outcome

Incidence of dissociation within 24 hours.
Time frame: Up to 24 hours after study drug infusion.
Dissociative symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion. A CADSS score of >4 points at any timepoint indicates occurrence of dissociative symptoms.

4 secondary outcomes

Severity of dissociative symptoms at different timepoints within 24 hours.
Time frame: Up to 24 hours after study drug infusion.
Prevelance of dissociation at different timepoints within 24 hours.
Time frame: Up to 24 hours after study drug infusion.
Incidence of neuropsychiatric adverse events within 24 hours.
Time frame: Up to 24 hours after study drug infusion.
Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.
Time frame: Up to 24 hours after study drug infusion.

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 30 Dec 2024.
Background: PubMed 9479681Bremner JD, Krystal JH, Putnam FW, Southwick SM, Marmar C, Charney DS, Mazure CM. Measurement of dissociative states with the Clinician-Administered Dissociative States Scale (CADSS). J Trauma Stress. 1998 Jan;11(1):125-36. doi: 10.1023/A:1024465317902.
Background: PubMed 26063213Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015 Jul;75(10):1119-30. doi: 10.1007/s40265-015-0419-5.
Background: PubMed 29282469Daly EJ, Singh JB, Fedgchin M, Cooper K, Lim P, Shelton RC, Thase ME, Winokur A, Van Nueten L, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):139-148. doi: 10.1001/jamapsychiatry.2017.3739.
Background: PubMed 29736744Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
Background: PubMed 35185548Lu X, Tang L, Lan H, Li C, Lin H. A Comparison of Intranasal Dexmedetomidine, Esketamine or a Dexmedetomidine-Esketamine Combination for Induction of Anaesthesia in Children: A Randomized Controlled Double-Blind Trial. Front Pharmacol. 2022 Jan 27;12:808930. doi: 10.3389/fphar.2021.808930. eCollection 2021.
Background: PubMed 33991996Mello RP, Echegaray MVF, Jesus-Nunes AP, Leal GC, Magnavita GM, Vieira F, Caliman-Fontes AT, Telles M, Guerreiro-Costa LNF, Souza-Marques B, Bandeira ID, Santos-Lima C, Marback RF, Correia-Melo FS, Lacerda ALT, Quarantini LC. Trait dissociation as a predictor of induced dissociation by ketamine or esketamine in treatment-resistant depression: Secondary analysis from a randomized controlled trial. J Psychiatr Res. 2021 Jun;138:576-583. doi: 10.1016/j.jpsychires.2021.05.014. Epub 2021 May 8.
Background: PubMed 37302963Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
Background: PubMed 38808490Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
Background: PubMed 38911034Yang JR, Li YY, Ran TJ, Lin XY, Xu JY, Zhou SL, Huang PJ. Esketamine Combined with Dexmedetomidine to reduce Visceral Pain During elective Cesarean Section Under Combined Spinal-Epidural Anesthesia: A double-Blind Randomized Controlled Study. Drug Des Devel Ther. 2024 Jun 18;18:2381-2392. doi: 10.2147/DDDT.S460924. eCollection 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.

Dong-Xin Wang, M.D., PhD. principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 30 Dec 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?

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 dissociation within 24 hours. (time frame: Up to 24 hours after study drug infusion.). 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 NCT06613243, which also lists 9 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 30 Dec 2024.