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Effect of Preoperative Dexmedetomidine Nasal Spray on Postoperative Recovery and Sleep Quality in Gynecologic Laparoscopic Total Hysterectomy: A Randomized, Double-blind, Placebo-Controlled Clinical Study

Effect of Preoperative Dexmedetomidine Nasal Spray on Postoperative Recovery and Sleep Quality in Gynecologic Laparoscopic Total Hysterectomy: A Randomized, Double-blind, Placebo-Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103050
Enrollment
Unknown
Registered
2025-05-23
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Laparoscopic total hysterectomy

Interventions

Dexmedetomidine hydrochloride nasal spray group (Group D):The day before surgery, dexmedetomidine hydrochloride nasal spray 100 µg was used before going to bed
Placebo group (N group):The day before surgery, use an isovolemic saline nasal spray before going to bed

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 5.1. Inclusion Criteria: (1) Age 18-60 years old; (2) ASA I-II. (3) Body mass index (BMI) 20 kg/m^2; (4) Elective gynecological laparoscopic total hysterectomy; (5) The start time of surgery is 08:00-14:00; (6) The estimated duration of the operation is 2-4 hours; (7) Voluntarily receiving dexmedetomidine nasal spray treatment; (8) The person and his family agree to participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 5.2. Exclusion Criteria: (1) ASAIII. level and above; (2) Patients with sleep apnea syndrome and other sleep disorders in the past; (3) Patients who need to take sleeping pills and sedatives for a long time; (4) Those who have combined psychiatric, nervous system diseases and functional disorders in the past and are unable to cooperate: (5) Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction; (6) Patients with a recent history of myocardial infarction, asthma, glaucoma, goiter, chronic obstructive pulmonary disease and other organ lesions; (7) Patients with prior bradyarrhythmia; (8) Those who are allergic to dexmedetomidine nasal spray; (9) Applicants who are deemed inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Quality of recovery 1 day after surgery;

Secondary

MeasureTime frame
Quality of recovery 2,3 day after surgery;Pain resting and exercise pain intensity within 72 hours after surgery;Intraoperative lowest systolic blood pressure and highest systolic blood pressure, lowest heart rate and highest heart rate;Total amount of opioids;Occurrence of postoperative adverse reactions;Postoperative recovery indicators (extubation time, time of first getting out of bed, time of gas, time of eating, time of removal of urinary catheter, length of hospital stay);;Postoperative complications;Pain intensity was performed one and three months after surgery;Sleep quality;Postoperative delirium;HOMA-IR insulin resistance index;

Countries

China

Contacts

Public ContactJiang Mengbi

Yichang Central People's Hospital

717266875@qq.com+86 138 7253 4239

Outcome results

None listed

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