Effect of dexmedetomidine combined with transcutaneous acupoint electrical stimulation on postoperative sleep quality of patients undergoing laparoscopic gynecological surgery

Effect of dexmedetomidine combined with transcutaneous acupoint electrical stimulation on postoperative sleep quality of patients undergoing laparoscopic gynecological surgery: a single-center randomized double-blind controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100004904

Enrollment

Unknown

Registered

2021-05-29

Start date

2021-08-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Postoperative Sleep Disturbances

Interventions

Group 2:Dexmedetomidine

Blank control group:None

Group 1:Transcutaneous electrical acupoint stimulation

Group 3:Transcutaneous electrical acupoint stimulation combined with dexmedetomidine

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective laparoscopic gynecological surgery; 2. Age: 18-60 years; 3. American Association of Anesthesiologists (ASA) grade I-III, BMI: 18.5 kg/m^2-28kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Pittsburgh sleep quality index score>7 points. 2. Sleep apnea, or moderate or more snoring. 3. Preoperative sinus bradycardia (heart rate less than 50 beats/min) or sinus node disease, second-degree or third-degree atrioventricular block, and pacemaker. 4. Long-term use of anticonvulsants, antidepressants or other psychotropic drugs. 5. Those who are highly sensitive or allergic to the drugs or equipment in this study. 6. Severe heart, liver or kidney disease. 7. Participated in other clinical trials in the past 3 months. 8. Have hearing and language communication barriers, unable to communicate effectively with doctors. 9. Patients who are pregnant or breastfeeding. 10. Those who need to clean the lymph nodes. 11. Patients with fever or infection before surgery.

Design outcomes

Primary

Measure	Time frame
Incidence of sleep disturbance in the first week after surgery;	—

Secondary

Measure	Time frame
Hospital Anxiety and Depression Scale Measurement (HADS) Score;Sedation (Ramsay) Score;Intraoperative fluid volume ;The incidence of postoperative adverse events;Intraoperative fluid output;Intraoperative body temperature changes;Resting Visual Analog Pain Score (VAS);Number of adverse events during surgery;Intraoperative rescue medication use;Intraoperative opioid dosage;Duration of operation;Duration of anesthesia;Athens Insomnia Score;Time for the first postoperative anus exhaust;Motion Visual Analog Pain Score (VAS);Pittsburgh Sleep Quality Index score;Total length of hospital stay;Dosage of postoperative analgesic drugs;	—

Measure

Time frame

Hospital Anxiety and Depression Scale Measurement (HADS) Score;Sedation (Ramsay) Score;Intraoperative fluid volume ;The incidence of postoperative adverse events;Intraoperative fluid output;Intraoperative body temperature changes;Resting Visual Analog Pain Score (VAS);Number of adverse events during surgery;Intraoperative rescue medication use;Intraoperative opioid dosage;Duration of operation;Duration of anesthesia;Athens Insomnia Score;Time for the first postoperative anus exhaust;Motion Visual Analog Pain Score (VAS);Pittsburgh Sleep Quality Index score;Total length of hospital stay;Dosage of postoperative analgesic drugs;

—

Countries

China

Contacts

Public ContactCheng Wei

53974314@qq.com+86 18052268817

Outcome results

None listed

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