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Comparison of sedative efficacy and safety of oliceridine or sufentanil combined with dexmedetomidine in fiberoptic bronchoscope-guided awake nasotracheal intubation for patients with difficult airway

Comparison of sedative efficacy and safety of oliceridine or sufentanil combined with dexmedetomidine in fiberoptic bronchoscope-guided awake nasotracheal intubation for patients with difficult airway

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117966
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult airway

Interventions

oliceridine + dexmedetomidine group (Group O):Within 15 minutes, administer dexmedetomidine 1 µg/kg intravenously via infusion pump. The O group received oxycodone 0.02 mg/kg intravenously.
Sufentanil + dexmedetomidine group (Group S):Within 15 minutes, administer dexmedetomidine 1 µg/kg intravenously via infusion pump. In the S group, administer sufentanil 0.1 µg/kg intravenously, follo

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 68 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~68 years old, gender is not limited; 2. Body mass index (BMI) 18-32 kg/m²; 3. American Society of Anaesthesiologists (ASA) class II or III; 4. The preoperative assessment meets the diagnostic criteria of difficult airway management in the Expert Consensus on Difficult Airway Management (2023 Edition), and any one of the following items is satisfied: (1) mouth opening <3 cm; (2) nail-chin spacing <6.5 cm; (3) Mallampati class ? or ?; (4) cervical spine mobility limitation (neck flexion or extension angle <30°); and (5) clear history of difficult intubation in the past; 5. Elective surgery under general anaesthesia with fibreoptic bronchoscopy-guided awake transnasal tracheal intubation is required; 6. signed informed consent by the patient or his/her legal representative.

Exclusion criteria

Exclusion criteria: 1. hypersensitivity to oxybutynin, sufentanil, dexmedetomidine or other drugs used in the trial (e.g. lidocaine); 2. Presence of coagulation disorders (prothrombin time, activated partial thromboplastin time exceeding 1.5 times the normal range); 3. Nasal anatomical deformity, stenosis or obstruction, which makes intubation through the nose impossible upon assessment; 4. Suffering from mental illness or cognitive dysfunction, unable to co-operate with the pre-operative assessment and intra-operative operation; 5. Combined serious cardiovascular disease (e.g. heart failure, serious arrhythmia, uncontrolled hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg)); 6. Preoperative respiratory insufficiency (SpO2 <95% at rest); 7. Pregnant or lactating women; 8. Participation in other clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxemia;

Secondary

MeasureTime frame
Number of coughing fits;Ramsay Sedation Scale;Respiratory indicators;

Countries

China

Contacts

Public ContactLI Peijun

Gansu Provincial Hospital

15294205253@163.com+86 152 9420 5253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026