The influence of seasonal factors on postoperative sleep quality of lower limb fractures with dexmedetomidine

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400088294

Enrollment

Unknown

Registered

2024-08-15

Start date

2022-11-07

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

lower extremity fracture

Interventions

Winter group:Winter

Summer group:Summer

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old; 2) ASA: Level I-III; 3) Choose a scheduled lower limb orthopedic surgery; 4) No previous history of mental illness or family history of mental illness; 5) No sleep disorders or pain hypersensitivity before surgery; 6) Informed consent to the surgical plan and signing of the informed consent form

Exclusion criteria

Exclusion criteria: 1) Individuals with severe liver or kidney function disorders or cardiovascular diseases; 2) There is a history of long-term use of sedative and hypnotic drugs and alcoholism; 3) There are contraindications for spinal anesthesia; 4) Body mass index>30 kg/m2; 5) Individuals who are allergic to dexmedetomidine; 6) Multiple fractures throughout the body; 7) Those who are unwilling to cooperate with this clinical study or unable to communicate effectively; 8)The researchers believe that it is not appropriate to include it in this experiment

Design outcomes

Primary

Measure	Time frame
Insomnia rate two days after surgery;	—

Secondary

Measure	Time frame
Record the BIS and OAA/S scores before medication (T0, baseline value), after infusion of loaded dose via micro pump (T1), and at 5 time points (T2-4) during maintenance of intravenous pump infusion at 10 min, 20 min, and 30 min (T2-4);Postoperative visual analog pain score at 1 and 2 days;Postoperative sleep: sleep quality, number of awakenings, time to fall asleep, total sleep time;Intraoperative duration: duration of right American pump infusion, duration of anesthesia, duration of surgery;Postoperative digestive function: time of first drinking/eating, time of first defecation;;Postoperative hypnosis and analgesic use: whether hypnotic drugs are taken, whether analgesic drugs are used, PCA frequency;	—

Measure

Time frame

Record the BIS and OAA/S scores before medication (T0, baseline value), after infusion of loaded dose via micro pump (T1), and at 5 time points (T2-4) during maintenance of intravenous pump infusion at 10 min, 20 min, and 30 min (T2-4);Postoperative visual analog pain score at 1 and 2 days;Postoperative sleep: sleep quality, number of awakenings, time to fall asleep, total sleep time;Intraoperative duration: duration of right American pump infusion, duration of anesthesia, duration of surgery;Postoperative digestive function: time of first drinking/eating, time of first defecation;;Postoperative hypnosis and analgesic use: whether hypnotic drugs are taken, whether analgesic drugs are used, PCA frequency;

—

Countries

China

Contacts

Public ContactErfei Zhang

Yan'an University Affiliated Hospital, No.43 North Street, Baota District, Yan'an City, Shaanxi Province

zhangerfei09@126.com+86 138 9117 0975

Outcome results

None listed

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