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Effects and mechanisms of perioperative application of dexketamine on psychological stress and postoperative pain in trauma patients

Effects and mechanisms of perioperative application of dexketamine on psychological stress and postoperative pain in trauma patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069349
Enrollment
Unknown
Registered
2023-03-14
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

psychological stress,postoperative pain

Interventions

Test group (K group):Before induction of general anesthesia, 0.5mg/kg dextamine was diluted to 10mL with normal saline and injected intravenously, followed by routine anesthesia induction.
Control group (group C):routine anesthesia induction regimen

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects with single traumatic lower limb fracture undergoing traumatic orthopedic surgery under tracheal intubation under general anesthesia; 2. Age 18-64 years old, male or female; 3. ASA I-III level; 4. Voluntarily joined and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are intolerant or allergic to dexketamine, propofol, opioids, dexmedetomidine and other general anesthesia drugs; 2. Used anesthesia within 24 hours before the first operation Subjects who took sexual analgesics; subjects who took long-term (continuous or intermittent) benzodiazepine sleeping pills, hormones, psychotropic drugs, and opioid analgesics; 3. Had a history of drug abuse and/or Subjects with a history of alcohol abuse; 4. Severe cardiovascular diseases (such as myocardial ischemia, angina pectoris, heart failure, and arrhythmia); or subjects with myocardial infarction within the last 6 months; 5. Preoperative Hypertensive subjects with unsatisfactory blood pressure control (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 100mmHg); 6. Subjects with decompensated shock; 7. Combined with internal organ damage (hepatic and spleen rupture, etc.) subjects; 8. Subjects with craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history and central nervous system diseases; 9. Subjects with mental illness (mental disease) before operation schizophrenia, mania, depression, etc.) and subjects with cognitive impairment; 10. Pregnant or lactating female subjects; 11. Subjects with hyperthyroidism; 12. Intraocular Subjects with elevated pressure (such as glaucoma) or combined ocular trauma; 13. Subjects who were judged to be difficult airway before operation (modified McMurley score was grade IV); 14. Subjects within the past 3 months who have participated in drug clinical trials as subjects.

Design outcomes

Primary

MeasureTime frame
Post Traumatic Stress Disorder Self-Rating Scale Score;

Secondary

MeasureTime frame
mean arterial pressure;heart rate;pulse oxygen saturation;stroke volume variation;pulse pressure variation;Systolic pressure;Diastolic pressure;Other hemodynamic parameters;date of surgery;Surgery and Duration of Anesthesia;blood pressure;temperature;blood sugar;age;Body Mass Index;American Society of Anesthesiologists grade;Surgical Apgar score;liquid intake and output volume;bispectral index;blood gas analysis;Pittsburgh sleep quality index;Self-rating depression scale;Self-Rating Anxiety Scale;Trauma Screening Question-naire;VAS pain assessment scale;8-concise quality of life scale;Stress response questionnaire;Other sleep and mood assessments;Midazolam;1% propofol;Vecuronium bromide;Fentanyl;Etomidate;Dextral ketamine;Sevoflurane;Dexamethasone;Dizoxin;Dexmetomidine;Remifentanil;Cis atracurium;2% propofol;Ephedrine;Dopamine;Norepinephrine;Norepinephrine;Uladeur;Nicardipine;Isoproterenol;other Vasoactive drug;Postoperative complication;Postoperative 30-day mortality;Postoperative ICU stay time;Postoperative hospital stay;Whether or not to be admitted to the hospital again and its reasons;Transfer after discharge from hospital;

Countries

China

Contacts

Public ContactZhengliang Ma

Nanjing Drum Tower Hospital

513665758@qq.com+86 25 8310 4616

Outcome results

None listed

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