Skip to content

The effective dose for successful insertion of a laryngeal mask and impact on discharge time of alfentanil combined with remimazolam besylate in ambulatory hysteroscopic surgery:a prospective,randomized,controlled clinical trial

The effective dose for successful insertion of a laryngeal mask and impact on discharge time of alfentanil combined with remimazolam besylate in ambulatory hysteroscopic surgery:a prospective,randomized,controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121808
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Endometrial polyps

Interventions

Trial 1:Alfentanil group (Group A) Modified Dixon sequential method: After 3 minutes of preoxygenation, remimazolam besylate 0.2 mg/kg was slowly administered intravenously over 60 seconds, followed b
Trial 2: Afentanil Group (AF Group):After 3 minutes of preoxygenation, administer remazolam besylate 0.2 mg/kg (IV over 60 seconds) followed by ED95 dose of alfentanil (ED95a, IV over 30 seconds). Mai
Trial 2 -Remifentanil Group (RF Group):After 3 minutes of preoxygenation, administer ED95 dose of remifentanil (ED95r) via infusion pump (infusion over 60 seconds), concurrently with remazolam besylat

Sponsors

Guabgzhou First People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. ASA grade I or grade II; 2. age ranged from 18 to 64 years; 3. Mouth opening >= 2.5cm; 4. Normal range of motion of head and neck; 5. Mallampati grade I or II;

Exclusion criteria

Exclusion criteria: 1. Body mass index > 30 kg/m^2 or < 18.5 kg/m^2; 2. Breastfeeding or pregnancy; 3. Severe liver disease; 4. Neuromuscular disorders; 5. Mental illness; 6. Metabolic diseases; 7. Drug or alcohol abuse; 8. The patient has contraindications for the use of benzodiazepines, sevoflurane, opioids, or dextran 40 (including a history of allergic reactions to these drugs); 9. Acute narrow angle glaucoma; 10. Shock or coma; 11. genetic diseases such as lactose intolerance, lactase deficiency, and glucose lactose malabsorption; 12. History of gastroesophageal reflux disease; 13. Acute upper respiratory tract infection; 14. Upper respiratory tract obstruction; 15. Long term use of sedatives or analgesics;

Design outcomes

Primary

MeasureTime frame
Laryngeal mask airway insertion success or failure;Discharge time after hysteroscopic day surgery (defined as time from end of surgery to Post-Anesthesia Discharge Scoring System [PADSS] score >=9);

Secondary

MeasureTime frame
Maximum and minimum mean arterial pressure and heart rate values from administration of remazolam or remifentanil to 5 minutes after laryngeal mask airway insertion;Time to loss of consciousness (LOC) and duration of apnea;Patient's bispectral index (BIS) value immediately before laryngeal mask airway insertion and adverse events during induction and insertion (including spontaneous breathing, breath-holding, stridor, or lacrimation);Postoperative recovery room follow-up for intraoperative awareness, nausea and vomiting, sore throat, and visual analog scale (VAS) score after awakening;Time to recovery of spontaneous breathing, adequate ventilation, response to verbal commands, laryngeal mask removal, recovery room stay duration, and time to ambulation;Surgical duration, anesthesia duration, satisfaction with anesthesia quality assessed by surgeon and patient, postoperative visual analog scale (VAS) score;Total number of intraoperative dose adjustments due to inadequate or excessive anesthesia depth per patient;All adverse events occurring during the trial period (including hypotension/hypertension, bradycardia/tachycardia, laryngospasm, hypoxemia, postoperative nausea and vomiting, hiccups, and intraoperative awareness);

Countries

China

Contacts

Public ContactCheng Aobing

Guabgzhou First People‘s Hospital

eychengaobing@scut.edu.cn+86 20 81048306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026