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Effect of low-dose esketamine on postoperative delirium in burn patients undergoing general anesthesia: a single-center, prospective, randomized, double-blind, placebo-controlled trial

Effect of low-dose esketamine on postoperative delirium in burn patients undergoing general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090863
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-04-24
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Postoperative delirium

Interventions

Esketamine group:In the study, the loading dose (0.25mg/kg) was given intravenously after induction and before operation, and the maintenance dose was given continuously at the rate of (0.125mg/kg/h)
saline control group:the control group was given in equal proportion

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.18-65 years old 2.TBSA>30% or ?>10% 3.ASA ?-? level 4. Patients undergoing burn scab grafting under general anesthesia 5. Voluntarily sign informed consen

Exclusion criteria

Exclusion criteria: 1. Patients with preoperative cognitive impairment 2. Preoperative MMSE score was low (MMSE200/110mmHg), or extremely unstable hemodynamics) 6. Patients taking antipsychotic drugs 7. Patients expected to be admitted to the ICU 8.BMI>30kg/m2 9. People with communication disabilities (inability to speak, language difficulty, severe visual or hearing impairment) 10. The expected operation time is less than 1h or longer than 4h 11. Alcohol or drug dependence (at least 3 months before the onset of the disease, drinking more than 100ml of alcohol at least 40 degrees per day; Can not get rid of the desire to use alcohol or drugs, the will to take this substance significantly increased)

Design outcomes

Primary

MeasureTime frame
The incidence of POD at 5 days after surgery;

Secondary

MeasureTime frame
The incidence of POD at 2 hours after surgery;The severity of POD at 2 hours after surgery and 1-5 days after surger;The pain score at 2 hours and 1-5 days after surgery;The sleep quality at 1-5 days after surgery;Mental state 2 hours after surgery;Occurrence of adverse reactions;

Countries

China

Contacts

Public ContactQianzi Yang

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

qianziyang@hotmail.com+86 191 0212 3726

Outcome results

None listed

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