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Clinical study on the effect of esmketamine combined with dexmedetomidine on perioperative neurocognitive disorder in elderly patients with general anesthesia

Clinical study on the effect of esmketamine combined with dexmedetomidine on perioperative neurocognitive disorder in elderly patients with general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038829
Enrollment
Unknown
Registered
2020-10-05
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative neurological dysfunction

Interventions

Group C:Intravenous infusion of 20 ml normal saline
Group K:Esmamine 0.3mg/kg was diluted into 20ml IV pump for 20min
Group D:Dexmedetomidine was given 1 µ g · kg-1 · H-1 IV pump for 20 min
Group DK:Esmamine 0.3mg/kg and Dexmedetomidine 1 µ g · kg-1 · H-1 IV pump for 20 min

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary participation and ability to provide informed consent. (2) Patients undergoing the following operations in our hospital: non cardiac surgery, such as chest surgery, macrovascular surgery, abdominal surgery, gynecological open surgery, urology open surgery, major orthopedic surgery, hepatobiliary surgery and ENT surgery. (3) Aged >= 65 years old, BMI 18-30 kg / m2; (4) Three months before screening, she did not participate in clinical trials of other drugs.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to active ingredients of dexmedetomidine or esmamine or all excipients; (2) Patients at serious risk of elevated blood pressure or intracranial pressure; (3) Poorly controlled or untreated hypertension (arterial hypertension, resting SBP / DBP over 180 / 100mmhg); (4) Combined with other important organ dysfunction: including severe liver and kidney dysfunction; brain organic disease, specifically refers to aneurysmal vascular disease or arteriovenous malformation and cerebral hemorrhage; severe hypertension, coronary heart disease, cardiac insufficiency (NYHA >= III), pulmonary hypertension; hematological diseases; coagulation dysfunction; severe respiratory diseases; severe respiratory diseases; severe hypertension, coronary heart disease, cardiac insufficiency (NYHA >= III grade), pulmonary hypertension; (5) Preeclampsia and eclampsia; (6) Untreated or undertreated patients with hyperthyroidism; (7) Use in cases where uterine muscle relaxation is required, for example, in the case of uterine laceration, umbilical cord prolapse; (8) A patient with a history of alcohol or drug dependence or drug abuse; (9) Patients taking antipsychotic drugs; Patients who were not considered suitable for inclusion by other researchers.

Design outcomes

Primary

MeasureTime frame
Incidence of PND;

Countries

China

Contacts

Public ContactGu Xiaoxia

Affiliated Hospital of Guangdong Medical University

343251863@qq.com+86 13729030217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026