Laparoscopic Cholecystectomy
Conditions
Interventions
Positive Pressure Ventilation Group:During induction: after loss of consciousness, rocuronium (0.6 mg/kg) was administered, followed by manual ventilation via face mask in pressure control mode (15 cm
then endotracheal intubation was performed. Maintenance included continuous intravenous infusion of remifentanil (0.1-0.2 µg/kg/min) and propofol (4-6 mg/kg/h), with intermittent boluses of rocuronium
Apneic Oxygenation Group:During induction: after loss of consciousness, rocuronium (0.6 mg/kg) was administered, followed by face mask administration of 100% oxygen at 6 L/min without positive pressur
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–60 years; 2. ASA physical status class I–II; 3. Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia with tracheal intubation; 4. No obvious hoarseness or voice difficulty before surgery, and able to complete the standardized preoperative and postoperative audio recording tasks; 5. Willing to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of previous voice abnormalities or laryngeal diseases: persistent hoarseness, known vocal cord polyps/nodules/paralysis, history of laryngeal or neck surgery, or chronic laryngeal/pharyngeal inflammation. 2. Acute upper respiratory tract or throat infection within 2 weeks before surgery (including pharyngitis, laryngitis, tonsillitis, or upper respiratory tract infection) with symptoms not fully resolved. 3. Professional voice users (such as teachers, singers, broadcasters, or salespersons who have special voice quality requirements). 4. Long-term smoking history (>=10 pack-years) or smoking cessation less than 4 weeks ago. 5. Predicted difficult airway (Mallampati classification grade III–IV, mouth opening 35 kg/m^2, edentulous, facial hair, or history of obstructive sleep apnea). 6. High risk of aspiration requiring rapid sequence induction (RSI), or conditions in which prolonged apnea should be avoided (e.g., full stomach, impaired gastric emptying, severe gastroesophageal reflux, or intestinal obstruction). 7. Cases in which intraoperative airway safety requires a change in the planned ventilation strategy or airway management method. 8. Severe cardiopulmonary disease intolerant to transient hypoxia or apnea (e.g., severe heart failure, pulmonary hypertension, or acute exacerbation of severe COPD/asthma). 9. Pregnancy or lactation. 10. Inability to cooperate with pre- or postoperative voice recording: cognitive impairment, hearing or speech disorders, language communication barriers, or psychiatric illness preventing cooperation. 11. Refusal to participate in the study or withdrawal of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?F0 (Change in fundamental frequency);?F0 SD (Change in standard deviation of fundamental frequency);?Jitter (Change in jitter);?Shimmer (Change in shimmer);?HNR (Change in harmonic-to-noise ratio);?CPP (Change in cepstral peak prominence);Safety outcomes (including: minimum SpO? during induction and hypoxemia incidence, change in mask ventilation strategy, intubation-related complications such as laryngospasm, aspiration, or airway injury, intraoperative hemodynamic changes, reintubation rate, and serious adverse events [SAE] incidence); | — |
Secondary
| Measure | Time frame |
|---|---|
| Voice hoarseness severity (graded 0–3);Pharyngeal pain severity (NRS 0–10);Dysphagia discomfort;Postoperative nausea and vomiting (PONV) incidence rate; | — |
Countries
China
Contacts
Public ContactZhang Yuwen
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed