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Esketamine versus remifentanil as adjuvant to remimazolam for laryngeal mask anesthesia with spontaneous ventilation in hysteroscopy: a randomized trial

Esketamine versus remifentanil as adjuvant to remimazolam for laryngeal mask anesthesia with spontaneous ventilation in hysteroscopy: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125823
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Gynecological Uterine Disease

Interventions

Control Group (Remifentanil Group):After the patient enters the operating room, the anesthesiologist sequentially administers intravenous injections of midazolam 0.05 mg/kg (injection rate: 2 mg/min),
Experimental Group (Esketamine Group):After the patient enters the operating room, the anesthesiologist intravenously injects midazolam at a dose of 0.05 mg/kg (injection rate: 2 mg/min), sufent

Sponsors

Anhui No.2 Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ,,( `=` ? `>=`,`=` ? `<=`,`m2` ? `m^2`,`109` ? `10^9`,`?` ? `II`),. `1.``2.``3.``4.`,: 1. Gender: Female; Age: 18~60 years old; Body Mass Index (BMI): 18.5~28 kg/m^2; American Society of Anesthesiologists (ASA) physical status classification: Grade I~II 2. Type of surgery: Elective hysteroscopic surgery (including hysteroscopy, hysteroscopic polypectomy, hysteroscopic myomectomy, etc.); 3. No contraindications to surgery and anesthesia; 4. Cognitive and compliance ability: Clear consciousness, able to understand the research purpose and procedures, and willing to cooperate with intraoperative monitoring and 24-hour postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Drug allergy: Those who are allergic to esketamine, remifentanil, remimazolam, midazolam, sufentanil and other research-related anesthetic drugs; 2. Organ dysfunction: Those with severe dysfunction of vital organs such as the heart, liver, kidney and lung; 3. Abnormal blood pressure: Those with uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); 4. Respiratory diseases: Patients with sleep apnea syndrome (SAS); 5. Difficult airway: Those with Mallampati grade III~IV, mouth opening < 3 cm, thyromental distance < 6 cm; 6. Contraindications to esketamine: Those with increased intracranial pressure, glaucoma, hyperthyroidism, or a history of mental illness; 7. Preoperative medication: Those who have used sedatives, analgesics or alcohol within 24 hours before surgery; 8. Special populations: Pregnant or lactating women; 9. Others: Those who are unable to cooperate with postoperative evaluation and follow-up, or refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Incidence of respiratory depression during maintenance period;

Secondary

MeasureTime frame
PACU stay time;Incidence of postoperative nausea and vomiting (PONV) within 2–24 hours after surgery;Time from drug discontinuation to laryngeal mask removal;24-hour postoperative QoR-15 score;Incidence of significant intraoperative body movement;Dosage of Remimazolam per unit time;

Countries

China

Contacts

Public ContactXiaolong Zhang

Anhui No.2 Provincial People's Hospital

zhangxl1458@126.com+86 136 8551 6500

Outcome results

None listed

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