ED90 of Tegileridine Combined With Propofol for LMA Insertion

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShiyou Wei

About this trial

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.

Eligibility criteria

Qualifiers

Elective surgery requiring general anesthesia with laryngeal mask airway insertion

Age ≥ 18 years

American Society of Anesthesiologists (ASA) physical status I-III

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tegileridine combined with Propofol for anesthesia induction

Treatment groups

108 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shiyou Wei

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution