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Effect of total intravenous anesthesia with opioid-free on the quality of recovery after gynecological laparoscopy: study protocol for a multi-center, prospective, double-blind, randomized controlled trial

Effect of total intravenous anesthesia with opioid-free on the quality of recovery after gynecological laparoscopy: study protocol for a multi-center, prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106392
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None

Interventions

Opioid-free anesthesia group (OFA group):Induction of anesthesia: dexmedetomidine 0.6 µg/kg pump for 10 minutes, esketamine 0.3 mg/kg, lidocaine 1 mg/kg, propofol 2-2.5 mg/kg, rocurbromide 0.6 mg/kg
Anesthesia maintenance: dexmedetomidine 0.2-0.7 µg/kg/h until half an hour before the end of surgery
Esketamine 0.1-0.2mg/kg was pushed intrastratively, and propofol was manually adjusted for pumping to maintain BIS 40-60.
Opioid-based anesthesia group (OBA group):Induction: Sufentanil 0.3 µg/kg, normal saline (volume-matched to lidocaine and dexmedetomidine), propofol 2–2.5 mg/kg, and rocuronium 0.6 mg/kg. Maintenanc

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female, age 18~65 years old; 2. American society of Anesthesiologists (ASA) Class I-III; 3. Patients who plan to undergo elective laparoscopic gynecological surgery (including oophorectomy, hysterectomy, salpingectomy, cystectomy and myomectomy) under general anesthesia with endotracheal intubation, and patients with single-port or multi-port laparoscopic surgery; 4. Have a clear understanding of the experimental process and voluntarily participate, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant, trying to become pregnant, or breastfeeding; 2. Extreme body mass index (BMI) 35kg/m^2; 3. Patients with a history of chronic pain (defined as pain that persists or recurs for more than 3 months) or who are taking any sedatives and analgesics; 4. Patients with severe mental or cognitive impairment that may affect the questionnaire assessment; 5. Patients with hypertension who have poor blood pressure control; 6. Sick sinus syndrome, severe bradycardia (<50 beats/min), more than two degrees of atrioventricular block without pacemaker, left ventricular ejection fraction <40%, coronary heart disease, myocardial infarction, severe cardiac insufficiency, severe liver and kidney insufficiency; 7. Patients with gastric ulcer, chronic renal function or liver failure 8. Patients with porphyria, epilepsy, Parkinson's and AD; 9. Patients who are allergic or incompatible with any of the study drugs and who participate in another interventional trial; 10. Inability to communicate effectively or refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
The quality of recovery;

Secondary

MeasureTime frame
The quality of recovery;Quality of life ;Incidence of chronic pain;Postoperative nausea and vomiting ;Numerical Rating Scale (NRS) pain scores;Postoperative opioid consumption ;

Countries

China

Contacts

Public ContactJi Fuhai

The First Affiliated Hospital of Soochow University

jifuhai@hotmail.com+86 136 5620 7331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026