Skip to content

Effects of esketamine on postoperative sleep quality and recovery in patients undergoing oral surgery: a prospective randomized controlled study

Effects of esketamine on postoperative sleep quality and recovery in patients undergoing oral surgery: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092053
Enrollment
Unknown
Registered
2024-11-08
Start date
2024-12-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

postoperative sleep disorder

Interventions

control group:normal saline (i.v.) after the induction of anesthesia
esketamine group:0.3mg/kg esketamine (i.v.) after the induction of anesthesia

Sponsors

The Third Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1, 18 to 65 years 2, ASA grade I ~ III level of patients 3, Patients undergoing oral and maxillofacial surgery (extraoral surgery) with general anesthesia 4, Voluntarily signed informed consent

Exclusion criteria

Exclusion criteria: 1, Recent history of drug abuse 2, Patients with preoperative cognitive dysfunction, communication disorders 3, Body mass index over 30 kg/m2 4, Preoperative sleep apnea syndrome, restless legs syndrome, etc. 5, Patients admitted to the intensive care unit after surgery 6, Liver and kidney dysfunction, the former is defined as aspartate amino transferase and (or) alanine aminotransferase levels greater than 1.5 times the upper limit of normal (ULN), the abnormal renal function is defined as serum creatinine greater than 1.5 times ULN 7, contraindicated of esketamine (be allergic to the ingredients of esketamine, at high risk of high blood pressure or high intracranial pressure, aortic dissection, poorly controlled or untreated hypertensive patients (more than 180/100 mmHg), preeclampsia and eclampsia, need to relax the uterine muscles).

Design outcomes

Primary

MeasureTime frame
sleep disorder one day after surgery;

Secondary

MeasureTime frame
sleep disorder 3, 5, 30 days after surgery;anxiety scores 1, 3, 5, and 30 days after surgery;agitation score during extubation;sore throat score after extubation;pain scores at 1, 3, and 5 days after surgery;length of stay;the changes of EEG after the administration of esketamine;

Countries

China

Contacts

Public ContactLiu Tiantian

The Third Affiliated Hospital of the Air Force Medical University

liusugar345@163.com+86 188 3516 2618

Outcome results

None listed

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