Oliceridine Dose for Tracheal Intubation Hemodynamic Elevation: Up-and-Down Trial

NCT07154979 | Completed

• 1 other identifier: 20250250
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial using an up-and-down sequential design, aiming to investigate the median effective dose (ED50) and 95% effective dose (ED95) of oliceridine for inhibiting hyperdynamic responses induced by tracheal intubation during general anesthesia induction. The study will enroll patients undergoing elective tracheal intubation under general anesthesia, stratified into young (18-65 years) and elderly (≥65 years) groups. By dynamically adjusting oliceridine doses, the optimal induction dose in different age groups will be evaluated to provide reference for rational clinical medication.

Conditions

Oliceridine

Keywords

oliceridine; dose-finding; µ-opioid receptor G-protein-biased agonist; up-and-down sequential design

Outcome Measures

Primary Outcomes (2)

• ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response

  95% effective dose (ED₉₅) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.

  From the start of intubation to 3 minutes after the end of intubation

• ED₅₀ of oliceridine for suppression of tracheal intubation-induced hemodynamic response

  Median effective dose (ED₅₀) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.

  From the start of intubation to 3 minutes after the end of intubation

Secondary Outcomes (1)

• The number of cases with coughing

  From the start of anesthesia induction to 3 minutes after the end of intubation

Other Outcomes (4)

• Changes in blood pressure at predefined time points

  From baseline through 3 minutes after tracheal intubation.

• The number of cases with adverse events

  up to 1 day after surgery

• Success rate of sedation

  From the start of intubation to 3 minutes after the end of intubation

Study Arms (1)

Oliceridine Up-and-Down Sequential Dose-Finding Arm

EXPERIMENTAL

In this single-group, up-and-down sequential design, adult patients receive a single intravenous bolus of oliceridine. * Initial dose: 45 µg/kg for ages 18-65 years; 40 µg/kg for ≥ 65 years * Two minutes later: propofol 2 mg/kg iv * At loss of consciousness (MOAA/S ≤ 1): rocuronium 0.6 mg/kg iv * Direct-laryngoscope tracheal intubation performed upon full muscle relaxation * Hemodynamic variables (BP, HR) recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation * A "positive" response (hemodynamic surge) is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg * Next patient's oliceridine dose is adjusted ± 3 µg/kg according to the preceding patient's response * Sequential dosing continues until seven crossovers are observed, allowing estimation of ED₅₀ and ED₉₅.

Drug: Oliceridine Injection

Interventions

Oliceridine Injection DRUG

Adult participants receive a single IV bolus of oliceridine (initial dose 45 µg/kg for ages 18-65 y or 40 µg/kg for ≥65 y). Two minutes later, propofol 2 mg/kg IV is administered. Upon loss of consciousness (MOAA/S ≤ 1), rocuronium 0.6 mg/kg IV is given. Direct laryngoscopic tracheal intubation is performed after full muscle relaxation. Blood pressure and heart rate are recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation. A "positive" hemodynamic response is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg. Subsequent oliceridine doses are adjusted ± 3 µg/kg based on the prior patient's response until seven response crossovers are observed, allowing estimation of ED₅₀ and ED₉₅.

Also known as: TRV130

Oliceridine Up-and-Down Sequential Dose-Finding Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery requiring general anesthesia with tracheal intubation
• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status I-III
• BMI\<25

You may not qualify if:

• At rest in the operating room, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
• Preoperative long-term use of analgesic or sedative medications
• Pregnancy, breastfeeding, known or planned pregnancy
• Known allergy or hypersensitivity to oliceridine or any study medication components
• History of psychiatric illness or inability to communicate effectively

Sponsors & Collaborators

• Shiyou Wei: lead

Study Sites (1)

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

Location

MeSH Terms

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine

Study Officials

• Shiyou Wei, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study; participants, investigators, and outcome assessors are aware of the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: A single-group, up-and-down sequential dose-finding design to determine the ED₅₀ and ED₉₅ of oliceridine for suppression of hemodynamic responses to tracheal intubation.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 4, 2025
• Study Start: September 4, 2025
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)