ED90 of Tegileridine Combined With Propofol for LMA Insertion

ConditionElective Surgery Requiring Laryngeal Mask Airway General Anesthesia

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

Tegileridine combined with Propofol for anesthesia induction
Drug
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.

Treatment groups

108 Participants

are divided into 1 treatment group

Group A: Single Group (All Adult Patients Aged ≥18 Years)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response

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.

Time frame

Within 3 minutes after laryngeal mask airway insertion

Secondary outcomes

Incidence of cough during 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.

Time frame

From the start of anesthesia induction to 3 minutes after the end of laryngeal mask airway insertion

Success rate of sedation

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.

Time frame

From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion

Other outcomes

Changes in blood pressure at predefined time points

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

Time frame

From baseline through 3 minutes after laryngeal mask airway insertion.

Heart rate at predefined time points

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.

Time frame

From baseline through 3 minutes after laryngeal mask airway insertion.

Incidence of perioperative adverse events

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.

Time frame

From anesthesia induction to 24 hours after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shiyou Wei

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Source ClinicalTrials.gov

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