Skip to content

Effect of simulated sleep structure general anesthesia on the quality of postoperative recovery in patients

Effect of simulated sleep structure general anesthesia on the quality of postoperative recovery in patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090268
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

breast cancer

Interventions

Simulate a group of sleep structures (group S):Maintain D2 stage for 1 hour under Narcotrend monitoring, then adjust to D2-C1 for half an hour, and repeat this cycle until maintaining C1-B1 stage for
Conventional anesthesia group(group C):Maintain D2 stage continuously under Narcotrend monitoring until switching to C1-B1 stage ten minutes before the end of the surgery. Stop the infusion of anesthe

Sponsors

Affiliated Bo'ai Hospital of Zhongshan, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participate in this study, have full civil capacity, and sign an informed consent form. (2) Patients who are scheduled to undergo modified radical mastectomy in our hospital. (3) Aged 18-65 years old, with a BMI of 18.5-27.9Kg/m2. (4) Have an American Society of Anesthesiologists (ASA) physical status classification of I-II and a surgical duration of =90 minutes. (5) Have not participated in any sleep therapy in the past 3 months prior to enrollment. (6) Have no history of sleep disorders, anxiety, depression, schizophrenia, or other psychiatric conditions.

Exclusion criteria

Exclusion criteria: (1) Concurrent significant organ dysfunction, including severe abnormalities in liver and kidney function; cerebral organic diseases, specifically referring to aneurysmal vascular diseases, arteriovenous malformations, and cerebral hemorrhage; severe hypertension, coronary heart disease, cardiac insufficiency (NYHA = III class), pulmonary hypertension; hematological disorders; coagulation abnormalities; severe respiratory diseases; mental disorders and cognitive impairments. (2) Patients with refractory hypertension, increased intracranial pressure, or increased intraocular pressure caused by various reasons. (3) Patients with untreated or inadequately treated hyperthyroidism. (4) Patients with a history of alcohol or drug dependence or drug abuse. (5) Patients with epilepsy, psychiatric illnesses, taking antipsychotic medications, or with a family history of genetic psychiatric illnesses. (6) Patients with severe infectious diseases. (7) Any other patients deemed unsuitable for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
15-item Quality of Recovery Scale score;

Secondary

MeasureTime frame
General Record;The incidence of intraoperative awareness in patients;Anesthetic dosage;Number of analgesic remedies within 48 hours after surgery;The patient's sleep condition ;

Countries

China

Contacts

Public ContactWei Zeng

Affiliated Bo'ai Hospital of Zhongshan, Southern Medical University

1796830968@qq.com+86 137 9073 2991

Outcome results

None listed

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