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Effects of compound chamomile and lidocaine hydrochloride gel on the complications related to laryngeal mask airway in surgery under general anesthesia: a prospective, multi-center, randomized, parallel controlled trial

Effects of compound chamomile and lidocaine hydrochloride gel on the complications related to laryngeal mask airway in surgery under general anesthesia: a prospective, multi-center, randomized, parallel controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067730
Enrollment
Unknown
Registered
2023-01-19
Start date
2023-01-20
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Complications related to laryngeal mask airway in surgery under general anesthesia

Interventions

control group:Laryngeal mask airway is lubricated with normal saline
treatment group:Laryngeal mask airway is lubricated with compound chamomile and lidocaine hydrochloride gel

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old; 2. Scheduled to undergo breast surgery, ophthalmic surgery, otologic surgery, endoscopic sinus surgery, urologic surgery, knee arthroscopic surgery, or hysteroscopic surgery; 3. 1 h <= indwelling time of LMA (estimated) <= 3 h; 4. ASA physical status I-II; 5. BMI is 18.5-29.9 kg/m2; 6. In line with ethics, the patient volunteered to be tested and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to the use of LMA or expected difficult airway; 2. Patients with a high risk of reflux aspiration (such as pregnancy, satiety, gastroesophageal reflux disease or esophageal hiatal hernia); 3. Glucocorticoids (dexamethasone, methylprednisolone, etc.) should be used during and after operation; 4. Non-steroidal anti-inflammatory drugs (flurbiprofen axetil, parecoxib sodium, etc.) should be used during and after operation; 5. Patients who are expected to use intravenous analgesia pumps after surgery; 6. Patients who are expected to be administered antagonists; 7. Have a history of acute upper respiratory tract infection, airway hyperresponsiveness (such as asthma),cough,expectoration or sore throat in the past 2 weeks; 8. Patients with other indwelling tubes (such as gastric tubes) in the oral cavity or nasal cavity during the perioperative period; 9. Complicated with important organ dysfunction or history of mental system disease; 10. Patients have contraindications or allergies to test drugs and other anesthetics used in this study; 11. Patients who participated in other studies within 30 days.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sore throat (NRS score>0 is defined as the occurrence of sore throat);

Secondary

MeasureTime frame
NRS score and PHPS score for postoperative sore throat;postoperative oropharyngeal mucositis score;hoarseness score;cough score;dry throat score;stress responses to removal of laryngeal mask airway (cough/bucking, agitation, nausea/retching, laryngeal/ bronchial spasm);hemodynamic changes during insertion and removal of laryngeal mask airway;time to successful LMA insertion and number of LMA insertion attempts;

Countries

China

Contacts

Public ContactGuyan Wang

Beijing Tongren Hospital, Capital Medical University

guyanwang2006@163.com+86 139 1098 5139

Outcome results

None listed

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