Older PatientsPhase 4NCT07914803
Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients
A Phase 4 study testing Intranasal dexmedetomidine-esketamine combination in people with Older Patients and Noncardiac Surgery, run by Peking University First Hospital at 1 site in China.
Trial summary
Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with worse outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Patients, Noncardiac Surgery, Dexmedetomidine
- What is being tested?
- Intranasal dexmedetomidine-esketamine combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 732 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Sep 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years.
- Scheduled to undergo noncardiac surgery under general anesthesia with an expected operative duration >1 hour.
- Planned hospital stay of at least 1 day.
Who cannot join
- Nasal disease precluding intranasal administration (e.g., rhinitis, nasal polyps, or nasal congestion of any cause).
- Pre-existing schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate preoperatively due to coma, severe dementia, or language disorder.
- History of craniocerebral injury or neurosurgery.
- Pre-existing sleep-disordered breathing (diagnosed sleep apnea or high risk of moderate-to-severe sleep apnea on the STOP-Bang questionnaire).
- History of hyperthyroidism or pheochromocytoma.
Show all 11Show fewer
- Preoperative LVEF <30%, sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min), or second-degree or higher atrioventricular block without a pacemaker.
- Severe hepatic dysfunction (Child-Pugh class C), severe renal impairment requiring preoperative dialysis, or ASA physical status ≥IV.
- Planned postoperative ICU admission.
- Known allergy or hypersensitivity to dexmedetomidine and/or esketamine.
- Any other condition that, in the judgment of the investigator, makes the patient unsuitable for enrollment.
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
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Huai-Jin Li, MD, +8613488659162, sophie.lee.coffee@gmail.com
About this study
Official title: Impact of Intranasal Dexmedetomidine-esketamine Combination on Neurocognitive Recovery in Older Patients After Noncardiac Surgery: a Randomized, Double-blind, and Placebo-controlled Trial
Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with worse outcomes. Intranasal dexmedetomidine, esketamine, and their combination have been used in clinical practice to improve sleep quality and analgesia. A preliminary study suggested lower rates of emergence delirium and POD/dNCR in older patients receiving perioperative intranasal dexmedetomidine-esketamine. This randomized controlled trial is designed to test the hypothesis that perioperative administration of an intranasal dexmedetomidine-esketamine combination improves neurocognitive recovery in older patients undergoing noncardiac surgery.
Read the detailed description
Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with prolonged hospitalization, worse functional recovery, and increased mortality. Disturbed sleep is a modifiable contributor: perioperative sleep disruption may amplify neuroinflammation, pain, and opioid requirements, creating a feed-forward loop that promotes neurocognitive complications.
Dexmedetomidine, a highly selective α2-adrenergic agonist, mimics aspects of physiological non-rapid eye movement (NREM) sleep. Intranasal dexmedetomidine has been used to improve perioperative sleep in older patients. Esketamine, the S-enantiomer of ketamine, provides analgesia and has rapid antidepressant effects. Intranasal esketamine is approved for treatment-resistant depression. Combined use of subanesthetic doses of esketamine and dexmedetomidine shows synergy in analgesia and anxiolysis, with fewer neuropsychiatric adverse effects.
Combining low doses of both agents for intranasal administration therefore targets several mechanisms implicated in POD and dNCR simultaneously (sleep restoration, analgesia, anxiolysis, and potentially reduced opioid consumption) via a noninvasive route feasible on surgical wards. A preliminary study suggested lower rates of emergence delirium and POD/dNCR in older patients receiving perioperative intranasal dexmedetomidine-esketamine.
This randomized controlled trial is designed to test the hypothesis that perioperative administration of an intranasal dexmedetomidine-esketamine combination improves neurocognitive recovery in older patients undergoing noncardiac surgery.
- Conditions
- Older Patients, Noncardiac Surgery, Dexmedetomidine, Esketamine, Intranasal Administration, Perioperative Neurocognitive Disorders
- Being tested
- Intranasal dexmedetomidine-esketamine combination, Intranasal placebo (0.9% saline)
- Keywords
- older patients, noncardiac surgery, dexmedetomidine, esketamine, intranasal administration, perioperative neurocognitive disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidine-esketamine combinationDrug
Also called DEX-ESK group
Participants in this group will receive intranasal administration of a dexmedetomidine-esketamine combination at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night.
Intranasal placebo (0.9% saline)Drug
Also called Placebo group
Participants in this group will receive intranasal administration of placebo (0.9% saline) at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night.
| Study group | Role | What they receive |
|---|---|---|
| DEX-ESK group | Experimental | Participants in this group will receive intranasal administration of a dexmedetomidine-esketamine combination at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. Receives: Drug: Intranasal dexmedetomidine-esketamine combination |
| Placebo group | Placebo comparator | Participants in this group will receive intranasal administration of placebo (0.9% saline) at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. Receives: Drug: Intranasal placebo (0.9% saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 4.
Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better function) before surgery and on postoperative day 4 or at hospital discharge, whichever occurs first. Delayed neurocognitive recovery (dNCR) is defined as a decline from baseline of >1 SD in MoCA score.
Measured: Up to 4 days after surgery.
Secondary outcomes (2)
Incidence of postoperative delirium within 3 days after surgery.
Delirium will be assessed twice daily during the first 3 postoperative days using the 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) in non-intubated patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in intubated patients.
Measured: Up to 3 days after surgery.
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 30.
Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher scores indicating better function) before surgery and on postoperative day 30. Delayed neurocognitive recovery (dNCR) is defined as a decline from baseline of >1 SD in T-MoCA score.
Measured: At 30 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 posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Older PatientsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 732 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914803
- Sponsor's protocol ID
- 2026R0664
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- 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
Rodrigues NB, McIntyre RS, Lipsitz O, Lee Y, Cha DS, Shekotikhina M, Vinberg M, Gill H, Subramaniapillai M, Kratiuk K, Lin K, Ho R, Mansur RB, Rosenblat JD. A simplified 6-Item clinician administered dissociative symptom scale (CADSS-6) for monitoring dissociative effects of sub-anesthetic ketamine infusions. J Affect Disord. 2021 Mar 1;282:160-164. doi: 10.1016/j.jad.2020.12.119. Epub 2020 Dec 29.
PubMed 33418362Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
PubMed 28263192Vasunilashorn SM, Guess J, Ngo L, Fick D, Jones RN, Schmitt EM, Kosar CM, Saczynski JS, Travison TG, Inouye SK, Marcantonio ER. Derivation and Validation of a Severity Scoring Method for the 3-Minute Diagnostic Interview for Confusion Assessment Method--Defined Delirium. J Am Geriatr Soc. 2016 Aug;64(8):1684-9. doi: 10.1111/jgs.14234. Epub 2016 Jul 4.
PubMed 27374833Lai Y, Zhao M, Jiang C, Du X, Wang Z, Zhang J, Bai Y, Xu B, Zhang W, Tang R, Sang C, Long D, Dong J, Ma C. Validation of T-MoCA in the Screening of Mild Cognitive Impairment in Chinese Patients With Atrial Fibrillation. Front Cardiovasc Med. 2022 Jun 22;9:896846. doi: 10.3389/fcvm.2022.896846. eCollection 2022.
PubMed 35811734Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.
PubMed 25700290Katz MJ, Wang C, Nester CO, Derby CA, Zimmerman ME, Lipton RB, Sliwinski MJ, Rabin LA. T-MoCA: A valid phone screen for cognitive impairment in diverse community samples. Alzheimers Dement (Amst). 2021 Feb 5;13(1):e12144. doi: 10.1002/dad2.12144. eCollection 2021.
PubMed 33598528Wei Q, Du B, Liu Y, Cao S, Yin S, Zhang Y, Ye R, Bai T, Wu X, Tian Y, Hu P, Wang K. The Montreal cognitive assessment: normative data from a large, population-based sample of Chinese healthy adults and validation for detecting vascular cognitive impairment. Front Neurosci. 2024 Jul 31;18:1455129. doi: 10.3389/fnins.2024.1455129. eCollection 2024.
PubMed 39145298Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Propofol compared with sevoflurane general anaesthesia is associated with decreased delayed neurocognitive recovery in older adults. Br J Anaesth. 2018 Sep;121(3):595-604. doi: 10.1016/j.bja.2018.05.059. Epub 2018 Jul 27.
PubMed 30115258Junior AB Jr, Bendazzoli PS, Ferreira Melo FW Jr, Porto Franco RM, de Sousa Rocha EM, Matos Lima RD, Brondi EB. Efficacy and Safety of the Ketamine-Dexmedetomidine Combination in Adult Sedation and Anesthesia: A Systematic Review and Single-Arm Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Nov 21;17(11):e97432. doi: 10.7759/cureus.97432. eCollection 2025 Nov.
PubMed 41431543Xu J, Jian J, Zhang Y, Wu J, Qiu Y. The efficacy of nasal administration of esketamine in patients having moderate-to-severe pain after preoperative CT-guided needle localization: a randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2024 Apr 9;11:1344160. doi: 10.3389/fmed.2024.1344160. eCollection 2024.
PubMed 38654836Sapkota A, Khurshid H, Qureshi IA, Jahan N, Went TR, Sultan W, Alfonso M. Efficacy and Safety of Intranasal Esketamine in Treatment-Resistant Depression in Adults: A Systematic Review. Cureus. 2021 Aug 21;13(8):e17352. doi: 10.7759/cureus.17352. eCollection 2021 Aug.
PubMed 34447651Molero 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 29736744Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.
PubMed 29870457Wolff K, Winstock AR. Ketamine : from medicine to misuse. CNS Drugs. 2006;20(3):199-218. doi: 10.2165/00023210-200620030-00003.
PubMed 16529526Barrett W, Buxhoeveden M, Dhillon S. Ketamine: a versatile tool for anesthesia and analgesia. Curr Opin Anaesthesiol. 2020 Oct;33(5):633-638. doi: 10.1097/ACO.0000000000000916.
PubMed 32826629
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
- Impact of Intranasal Dexmedetomidine-esketamine Combination on Neurocognitive Recovery in Older Patients After Noncardiac Surgery: a Randomized, Double-blind, and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07914803
- Acronym / sponsor ID
- 2026R0664
- Conditions
- Older Patients, Noncardiac Surgery, Dexmedetomidine, Esketamine, Intranasal Administration, Perioperative Neurocognitive Disorders
- Keywords
- older patients, noncardiac surgery, dexmedetomidine, esketamine, intranasal administration, perioperative neurocognitive disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 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 neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with worse outcomes. Intranasal dexmedetomidine, esketamine, and their combination have been used in clinical practice to improve sleep quality and analgesia. A preliminary study suggested lower rates of emergence delirium and POD/dNCR in older patients receiving perioperative intranasal dexmedetomidine-esketamine. This randomized controlled trial is designed to test the hypothesis that perioperative administration of an intranasal dexmedetomidine-esketamine combination improves neurocognitive recovery in older patients undergoing noncardiac surgery.
Detailed description
Postoperative neurocognitive disorders, including postoperative delirium (POD) and delayed neurocognitive recovery (dNCR), are common in older patients undergoing surgery and are associated with prolonged hospitalization, worse functional recovery, and increased mortality. Disturbed sleep is a modifiable contributor: perioperative sleep disruption may amplify neuroinflammation, pain, and opioid requirements, creating a feed-forward loop that promotes neurocognitive complications.
Dexmedetomidine, a highly selective α2-adrenergic agonist, mimics aspects of physiological non-rapid eye movement (NREM) sleep. Intranasal dexmedetomidine has been used to improve perioperative sleep in older patients. Esketamine, the S-enantiomer of ketamine, provides analgesia and has rapid antidepressant effects. Intranasal esketamine is approved for treatment-resistant depression. Combined use of subanesthetic doses of esketamine and dexmedetomidine shows synergy in analgesia and anxiolysis, with fewer neuropsychiatric adverse effects.
Combining low doses of both agents for intranasal administration therefore targets several mechanisms implicated in POD and dNCR simultaneously (sleep restoration, analgesia, anxiolysis, and potentially reduced opioid consumption) via a noninvasive route feasible on surgical wards. A preliminary study suggested lower rates of emergence delirium and POD/dNCR in older patients receiving perioperative intranasal dexmedetomidine-esketamine.
This randomized controlled trial is designed to test the hypothesis that perioperative administration of an intranasal dexmedetomidine-esketamine combination improves neurocognitive recovery in older patients undergoing noncardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX-ESK group | Experimental | Drug: Intranasal dexmedetomidine-esketamine combinationParticipants in this group will receive intranasal administration of a dexmedetomidine-esketamine combination at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. |
| Placebo group | Placebo comparator | Drug: Intranasal placebo (0.9% saline)Participants in this group will receive intranasal administration of placebo (0.9% saline) at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years.
- Scheduled to undergo noncardiac surgery under general anesthesia with an expected operative duration >1 hour.
- Planned hospital stay of at least 1 day.
Key exclusion criteria (11 listed)
- Nasal disease precluding intranasal administration (e.g., rhinitis, nasal polyps, or nasal congestion of any cause).
- Pre-existing schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate preoperatively due to coma, severe dementia, or language disorder.
- History of craniocerebral injury or neurosurgery.
- Pre-existing sleep-disordered breathing (diagnosed sleep apnea or high risk of moderate-to-severe sleep apnea on the STOP-Bang questionnaire).
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 |
|---|---|---|
| Intranasal dexmedetomidine-esketamine combinationAlso: DEX-ESK groupParticipants in this group will receive intranasal administration of a dexmedetomidine-esketamine combination at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. | Drug | DEX-ESK group |
| Intranasal placebo (0.9% saline)Also: Placebo groupParticipants in this group will receive intranasal administration of placebo (0.9% saline) at bedtime (8-9 pm) three times: the night before surgery, the night of surgery, and the first postoperative night. | Drug | Placebo group |
Primary outcome
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 4.
Time frame: Up to 4 days after surgery.
Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better function) before surgery and on postoperative day 4 or at hospital discharge, whichever occurs first. Delayed neurocognitive recovery (dNCR) is defined as a decline from baseline of >1 SD in MoCA score.
2 secondary outcomes
Incidence of postoperative delirium within 3 days after surgery.
Time frame: Up to 3 days after surgery.
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 30.
Time frame: At 30 days after surgery.
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 33418362Rodrigues NB, McIntyre RS, Lipsitz O, Lee Y, Cha DS, Shekotikhina M, Vinberg M, Gill H, Subramaniapillai M, Kratiuk K, Lin K, Ho R, Mansur RB, Rosenblat JD. A simplified 6-Item clinician administered dissociative symptom scale (CADSS-6) for monitoring dissociative effects of sub-anesthetic ketamine infusions. J Affect Disord. 2021 Mar 1;282:160-164. doi: 10.1016/j.jad.2020.12.119. Epub 2020 Dec 29.
- Background: PubMed 28263192Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.
- Background: PubMed 27374833Vasunilashorn SM, Guess J, Ngo L, Fick D, Jones RN, Schmitt EM, Kosar CM, Saczynski JS, Travison TG, Inouye SK, Marcantonio ER. Derivation and Validation of a Severity Scoring Method for the 3-Minute Diagnostic Interview for Confusion Assessment Method--Defined Delirium. J Am Geriatr Soc. 2016 Aug;64(8):1684-9. doi: 10.1111/jgs.14234. Epub 2016 Jul 4.
- Background: PubMed 35811734Lai Y, Zhao M, Jiang C, Du X, Wang Z, Zhang J, Bai Y, Xu B, Zhang W, Tang R, Sang C, Long D, Dong J, Ma C. Validation of T-MoCA in the Screening of Mild Cognitive Impairment in Chinese Patients With Atrial Fibrillation. Front Cardiovasc Med. 2022 Jun 22;9:896846. doi: 10.3389/fcvm.2022.896846. eCollection 2022.
- Background: PubMed 25700290Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.
- Background: PubMed 33598528Katz MJ, Wang C, Nester CO, Derby CA, Zimmerman ME, Lipton RB, Sliwinski MJ, Rabin LA. T-MoCA: A valid phone screen for cognitive impairment in diverse community samples. Alzheimers Dement (Amst). 2021 Feb 5;13(1):e12144. doi: 10.1002/dad2.12144. eCollection 2021.
- Background: PubMed 39145298Wei Q, Du B, Liu Y, Cao S, Yin S, Zhang Y, Ye R, Bai T, Wu X, Tian Y, Hu P, Wang K. The Montreal cognitive assessment: normative data from a large, population-based sample of Chinese healthy adults and validation for detecting vascular cognitive impairment. Front Neurosci. 2024 Jul 31;18:1455129. doi: 10.3389/fnins.2024.1455129. eCollection 2024.
- Background: PubMed 30115258Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Propofol compared with sevoflurane general anaesthesia is associated with decreased delayed neurocognitive recovery in older adults. Br J Anaesth. 2018 Sep;121(3):595-604. doi: 10.1016/j.bja.2018.05.059. Epub 2018 Jul 27.
- Background: PubMed 41431543Junior AB Jr, Bendazzoli PS, Ferreira Melo FW Jr, Porto Franco RM, de Sousa Rocha EM, Matos Lima RD, Brondi EB. Efficacy and Safety of the Ketamine-Dexmedetomidine Combination in Adult Sedation and Anesthesia: A Systematic Review and Single-Arm Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Nov 21;17(11):e97432. doi: 10.7759/cureus.97432. eCollection 2025 Nov.
- Background: PubMed 38654836Xu J, Jian J, Zhang Y, Wu J, Qiu Y. The efficacy of nasal administration of esketamine in patients having moderate-to-severe pain after preoperative CT-guided needle localization: a randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2024 Apr 9;11:1344160. doi: 10.3389/fmed.2024.1344160. eCollection 2024.
- Background: PubMed 34447651Sapkota A, Khurshid H, Qureshi IA, Jahan N, Went TR, Sultan W, Alfonso M. Efficacy and Safety of Intranasal Esketamine in Treatment-Resistant Depression in Adults: A Systematic Review. Cureus. 2021 Aug 21;13(8):e17352. doi: 10.7759/cureus.17352. eCollection 2021 Aug.
- 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.
- 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.
Dong-Xin Wang, MD, 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?
A Phase 4 study testing Intranasal dexmedetomidine-esketamine combination in people with Older Patients and Noncardiac Surgery, run by Peking University First 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 3 inclusion and 11 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: opening soon, 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. 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.
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?
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 Dong-Xin Wang, MD, PhD (86 10 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed neurocognitive recovery (dNCR) on postoperative day 4. (time frame: Up to 4 days after surgery.). 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 NCT07914803, which also lists 42 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 4 Nov 2026.