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Efficacy of Intraoperative Lidocaine Infusion on Postoperative Sleep Disturbance After Gynecological Open Surgery

Efficacy of Intraoperative Lidocaine Infusion on Postoperative Sleep Disturbance After Gynecological Open Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086942
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-22
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Benign gynecological tumors, Adenomyosis, etc

Interventions

Lidocaine group:A single injection of 1.5mg/kg before anesthesia induction, slowly administered
Then infusion of 1.5mg/kg/h until the end of the surgery, the postoperative PCIA device will contain lidocaine 36mg/kg and sufentanil 2ug/kg, diluted to 200 mL in 0.9% physiological saline. The backgr
Control group:Preoperative and intraoperative physiological saline infusion at the same speed, postoperative PCIA device with sufentanil 2ug/kg, background infusion set at 4mL/h, each PCIA press with

Sponsors

Peking University of Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
33 Years to 54 Years

Inclusion criteria

Inclusion criteria: 1.33-54 year old ASAI-III grade female patients; 2. Choose a suitable time for gynecological benign disease lower abdominal open surgery (transabdominal hysterectomy, myomectomy, salpingo oophorectomy, cystectomy, or adenomyomectomy, etc.); 3. No recent respiratory infections or severe allergic reactions; 4. The estimated end time of the surgery is before 16:00

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of sleep apnea syndrome, history of sleep disorders, or STOPBang score greater than or equal to 3 points; 2. Unable to communicate before surgery due to coma, severe dementia, language disorders, or serious illness; 3. Severe liver dysfunction (ChildePugh C-grade); Or require preoperative dialysis; 4. Weight100kg; 5. Patients refuse or are unable to use intravenous analgesia pumps; 6. Preoperative left ventricular ejection fraction<30%, severe arrhythmia, including preexcitation syndrome, pathological sinus syndrome, severe bradycardia (heart rate<50 beats per minute), or second or higher degree atrioventricular block without a pacemaker; 7. Lidocaine allergy patients;

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative sleep disorders;

Secondary

MeasureTime frame
Postoperative sleep staging;HADs;Qor-15 postoperative recovery quality score;Opioid consumption at 24 hours after surgery/resting pain score and exercise pain score at 24 and 48 hours after surgery;Postoperative nausea and vomiting score;hospital stay;Time of first defecation and time of first exhaust;

Countries

China

Contacts

Public ContactTao Luo

Peking University of Shenzhen Hospital

496855048@qq.com+86 135 1082 0779

Outcome results

None listed

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