ED90 of Teglidine for Suppressing LMA Insertion Response in the Elderly

Launched by THE FIRST PEOPLE'S HOSPITAL OF LIANYUNGANG · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best dose of a medicine called taiglididine to help reduce the body’s reaction when a breathing mask (called a laryngeal mask) is placed during surgery in elderly patients. This mask is used to help patients breathe while they are under general anesthesia for urological surgery (surgery related to the urinary system). The goal is to find the dose that works well for 90% of patients without causing unwanted side effects.

The study will include 54 patients aged 65 to 80 who are generally healthy enough for surgery and anesthesia, with a body weight within a normal range. To join, patients must not have serious heart, lung, or nerve problems, and must be scheduled for a surgery lasting less than three hours using the breathing mask. Participants will receive different doses of taiglididine through an IV before anesthesia, and the dose will be adjusted based on how well it controls the body’s response to the mask. Throughout the process, doctors will carefully watch vital signs like heart rate and blood pressure to make sure the medicine is safe. This study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 65-80 years old.
• • 2. ASA physical status I-III.
• • 3. BMI 18-30 kg/m² (inclusive of critical values).
• • 4. Mallampati class I or II, mouth opening \>2.5 cm.
• • 5. No abnormal airway or head/neck conditions.
• • 6. No risk of reflux or aspiration (e.g., full stomach, obesity, gastrointestinal obstruction).
• • 7. Expected surgery duration \<180 min.
• • 8. Scheduled for urological surgery requiring general anesthesia and laryngeal mask insertion.
• • 9. 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.