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Effect of laryngeal mask combined with no muscle relaxation on postoperative recovery quality of patients with radical mastectomy

Effect of laryngeal mask combined with no muscle relaxation on postoperative recovery quality of patients with radical mastectomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094602
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-12-27
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

breast cancer

Interventions

control group:Midazolam 0.08 mg/kg, Penehyclidine Hydrochloride (Penehyclidine Hydrochloride) 0.5 mg, Sufentanil 0.5 ug/kg and Propofol 1.5- 2.0 mg/kg were injected intravenously slowly in sequence. A
experimental group :Midazolam 0.08 mg/kg, sufentanil 0.5µg/kg and propofol 1.5- 2.0 mg/kg were injected slowly in sequence. The eyelash reflex disappeared and laryngeal mask was inserted. Auscultation

Sponsors

The First Affiliated Hospial of Gannan Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female patients aged 18-65 years; ASA classification: I-II; Body mass index (BMI) between 18 and 28 kg/m2; Female patients undergoing radical mastectomy under general anesthesia; Patients are informed about the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: Full stomach, non-fasting patients; Known or predicted difficult airway or failed 2 attempts to insert LMA mask; Patients at risk for reflux, such as obesity, hiatal hernia, pregnancy, and patients with a history of gastric content reflux; Patients with tracheal compression and tracheomalacia; patients with throat lesions, or lesions leading to upper respiratory tract obstruction; Combined with severe heart, lung, liver and kidney function diseases, or combined with severe hypertension and diabetes; History of mental or neurological disorders, alcohol and drug abuse, chronic use of opioids or sedatives; Patients with severe lung diseases (such as COPD, bronchial asthma, emphysema, bullae, bronchiectasis, etc.)

Design outcomes

Primary

MeasureTime frame
QoR-15 total score before operation and 24h, 48h and 72h after operation;

Secondary

MeasureTime frame
Pulmonary ultrasound scores before induction of anesthesia and before exit from the anesthesia resuscitation room;MAP and HR were recorded at T0 (1min before intubation or laryngeal mask insertion), T1(1min after intubation or laryngeal mask insertion) and T2 (1min after extubation or removal of laryngeal mask); Peak airway pressure at T2 and 60min during operation;The recovery time (from drug withdrawal to extubation) and the duration of stay in recovery room ;The incidence of sore throat 30min after extubation and 24h after operation, nausea and vomiting within 2h after operation and the incidence of oxygen saturation decrease < 95%, blood gas analysis before operation and 15min after extubation;Incidence of cough and body movement reaction during operation;Total intraoperative opioid use and intraoperative vasoactive drug use rate;Patient satisfaction score (0-10 points), first time out of bed after surgery;

Countries

China

Contacts

Public ContactRui Guo

The First Afiliated Hospitaf of Gannan Medical University

haiou2018guo@163.com+86 159 0707 4021

Outcome results

None listed

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