ED90 of Teglidine for Suppressing LMA Insertion Response in the Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Taiglididine.
- Who it may be relevant to
- Registry conditions: Urological Surgery. Basic parameters: 65 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The 90% Effective Dose of Taiglididine for Inhibiting Laryngeal Mask Insertion Response in Elderly Patients
Overview
This research protocol aims to investigate the 90% effective dose (ED90) of taiglididine for inhibiting laryngeal mask insertion response in elderly patients. It is a non-randomized controlled trial using a biased coin design up-down method (BCD-UDM). A total of 54 elderly patients aged 65-80 years with ASA I-III, BMI 18-30 kg/m², and suitable for urological surgery under general anesthesia with laryngeal mask insertion will be enrolled. The first patient receives an intravenous injection of 1 mg taiglididine, followed by propofol and rocuronium. Subsequent doses of taiglididine are adjusted dynamically based on the previous patient's response: increasing by 0.1 mg if the insertion response is positive, or using BCD-UDM (11% probability to decrease by 0.1 mg, 89% to remain) if negative. The primary efficacy endpoint is the occurrence of laryngeal mask insertion response, while secondary endpoints include adverse events, vital sign changes, insertion success rate, and various time intervals. Safety is evaluated by monitoring vital signs. Statistical analysis will use SPSS 25.0 and R software to calculate ED90 and 95% confidence intervals via probit regression and bootstrap method, with at least 45 valid patients required to complete the trial.
Interventions
- Drug Taiglididine
The first patient receives an intravenous injection of 1 mg taiglididine for anesthesia induction, followed by 1-2 mg/kg propofol. When the patient's bispectral index (BIS) drops below 60, eyelash reflex disappears, and MOAA/S score is 0, intravenous rocuronium 0.6 mg/kg is given, and a laryngeal mask is inserted by a senior anesthesiologist using a unified method 1 min later. From the second patient onward, the taiglididine dose is dynamically adjusted based on the previous patient's response t
Primary outcome measures
- Number of patients with positive laryngeal mask insertion response [Time frame: Perioperative]
Secondary outcome measures (3)
- Number of adverse reactions [Time frame: Perioperative]
- Number of successful cases of laryngeal mask placement [Time frame: Perioperative]
- Adverse reactions such as pain, dizziness, headache, nausea and vomiting, sore throat, chills, choking, agitation, hoarseness of voice, and Intraoperative knowledge [Time frame: Perioperative]
Eligibility criteria
Inclusion criteria
- Aged 65-80 years old.
- ASA physical status I-III.
- BMI 18-30 kg/m² (inclusive of critical values).
- Mallampati class I or II, mouth opening >2.5 cm.
- No abnormal airway or head/neck conditions.
- No risk of reflux or aspiration (e.g., full stomach, obesity, gastrointestinal obstruction).
- Expected surgery duration <180 min.
- Scheduled for urological surgery requiring general anesthesia and laryngeal mask insertion.
- Voluntary participation with signed informed consent.
Exclusion criteria
Baseline measurements: Severe hypertension (SBP >160 mmHg or DBP >100 mmHg), heart rate <60 bpm or >100 bpm.
2\. History of long-term alcohol, sedative, or analgesic use; allergy to any study drugs.
3\. Severe dysfunction of vital organs (heart, lung, liver, kidney, nervous system), neuromuscular diseases, hyperthyroidism, obstructive sleep apnea syndrome.
4\. History of mental disorders or cognitive impairment severe enough to hinder understanding or cooperation with the study.
5\. Preoperative administration of sedative-hypnotics (including benzodiazepines and barbiturates).
6\. Upper respiratory tract infection within 1 month before surgery. 7. Participation in other clinical studies within the past 3 months. 8. Other conditions deemed unsuitable for the trial by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07096115 · KY-20250324002-01