ED90 of Teglidine for Suppressing LMA Insertion Response in the Elderly

NCT07096115 | Not Yet Recruiting DMC

• 1 other identifier: KY-20250324002-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urological Surgery

Keywords

Taiglididine; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• Number of patients with positive laryngeal mask insertion response

  If the patient has movement during laryngeal mask insertion, twitching at the corner of the mouth, coughing, frowning, tearing, laryngospasm, bispectral index not decreasing to below 60, an increase in heart rate or blood pressure of more than 20% of the baseline value within 2 minutes after laryngeal mask insertion, tachycardia (heart rate \>120 beats per minute), or hypertension (systolic blood pressure \>180 mmHg), and one of these occurs, it is determined as a positive laryngeal mask insertion reaction; otherwise, it is negative.

  Perioperative

Secondary Outcomes (3)

• Number of adverse reactions

  Perioperative

• Number of successful cases of laryngeal mask placement

  Perioperative

• Adverse reactions such as pain, dizziness, headache, nausea and vomiting, sore throat, chills, choking, agitation, hoarseness of voice, and Intraoperative knowledge

  Perioperative

Study Arms (1)

Taiglididine Sequential Dose-Finding for LMA Insertion Suppression

EXPERIMENTAL

Drug: Taiglididine

Interventions

Taiglididine DRUG

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 to laryngeal mask insertion using BCD-UDM: if the previous patient shows a positive insertion response (positive response or MOAA/S ≥2 within 2 min after induction), the next patient's dose increases by 0.1 mg; if negative, a random number (1-95) generated by computer determines the dose: doses remain unchanged when the number is 6-95 (89% probability) and decrease by 0.1 mg when the number is 1-5 (11% probability). A collaborator not involved in result evaluation provides a sealed envelope with

Taiglididine Sequential Dose-Finding for LMA Insertion Suppression

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Baseline measurements: Severe hypertension (SBP \>160 mmHg or DBP \>100 mmHg), heart rate \<60 bpm or \>100 bpm.
• \. History of long-term alcohol, sedative, or analgesic use; allergy to any study drugs.
• \. Severe dysfunction of vital organs (heart, lung, liver, kidney, nervous system), neuromuscular diseases, hyperthyroidism, obstructive sleep apnea syndrome.
• \. History of mental disorders or cognitive impairment severe enough to hinder understanding or cooperation with the study.
• \. Preoperative administration of sedative-hypnotics (including benzodiazepines and barbiturates).
• \. 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.

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Central Study Contacts

zhibin Zhao

CONTACT

+8618961326661; lygzhaozhibin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share