ED90 of Tegileridine Combined With Propofol for LMA Insertion
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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: Tegileridine combined with Propofol for anesthesia induction.
- Who it may be relevant to
- Registry conditions: Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia. Basic parameters: from 18 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
- China
- 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
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
Overview
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.
Interventions
- Drug Tegileridine combined with Propofol for anesthesia induction
Intravenous 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 outcome measures
- 90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response [Time frame: Within 3 minutes after laryngeal mask airway insertion]
Secondary outcome measures (2)
- 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]
- Success rate of sedation [Time frame: From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Te — Tianmen
Identifiers
NCT: NCT07665151 · tianmen20260016