Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Tianmen, Hubei, 431700, China
Not Yet Recruiting
NCT Number: NCT07665151
ED90 of Tegileridine Combined With Propofol for LMA Insertion
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-65 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Elective surgery requiring general anesthesia with laryngeal mask airway insertion
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
Exclusion criteria
- At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- Continuous opioid medication for more than 2 weeks within half a year before surgery
- Known allergy or hypersensitivity to tegileridine or any study medication components
- History of psychiatric illness or inability to communicate effectively
Treatment and study plan
Tegileridine combined with Propofol for anesthesia induction
DrugIntravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg/kg for general anesthesia induction before laryngeal mask airway placement.
Primary outcomes
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90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response
Time frame: Within 3 minutes after laryngeal mask airway insertion
The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure/heart rate increase over 20% compared with baseline within 3 minutes after LMA placement.
Secondary outcomes
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Incidence of cough during laryngeal mask airway insertion
Time frame: From the start of anesthesia induction to 3 minutes after the end of laryngeal mask airway insertion
During anesthesia induction, intravenous injection of opioids may cause coughing. During the after laryngeal mask airway insertion process, coughing may occur due to airway stimulation.
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Success rate of sedation
Time frame: From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion
The modified observer's assessment of alert/sedation scale (MOAA/S) is a commonly - used sedation evaluation tool in clinical practice. It classifies reactivity under different stimuli: Grade 5 means a sensitive response to calling the name in a normal tone of voice; Grade 4 indicates a sluggish response to calling the name in a normal tone of voice; Grade 3 requires a loud or repeated call of the name to elicit a response; Grade 2 shows a response to slight pushing and vibration; Grade 1 has a response to a painful stimulus (by squeezing the trapezius muscle area); Grade 0 means no response to a painful stimulus. Moreover, MOAA/S ≤ 2 indicates loss of consciousness, which can assist medical staff in judging the sedation level and consciousness state of patients.
Other outcomes
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Changes in blood pressure at predefined time points
Time frame: From baseline through 3 minutes after laryngeal mask airway insertion.
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) are recorded at:
Baseline (prior to tegileridine administration) ,2 minutes after tegileridine bolus, Immediately before laryngeal mask airway insertion, The highest values within 3 minutes following insertion
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Heart rate at predefined time points
Time frame: From baseline through 3 minutes after laryngeal mask airway insertion.
Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before laryngeal mask airway insertion, and the peak value within 3 minutes after insertion.
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Incidence of perioperative adverse events
Time frame: From anesthesia induction to 24 hours after surgery
The proportion of participants with perioperative adverse reactions including hypotension, bradycardia, arrhythmia, palpitations, dizziness, hypersensitivity, nausea and vomiting, laryngospasm, pruritus, respiratory depression. All adverse events from anesthesia induction to 24 hours postoperatively will be recorded.
Study contacts
Contact information is provided by the study sponsor or research team.
Jianmang Y Yu
CONTACT
Shiyou W Wei
CONTACT
Sponsors and collaborators
Lead sponsor
Shiyou Wei
Other
Registry information
Official study title
90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 24, 2026
- Registry last updated
- Jun 29, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.