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Effect of Topical Spray of Dexmedetomidine Combined with Ropivacaine on Postoperative Sore Throat After Double-Lumen Endotracheal Intubation: A Prospective, Randomized, Double-Blind, Controlled Clinical Study

Effect of Topical Spray of Dexmedetomidine Combined with Ropivacaine on Postoperative Sore Throat After Double-Lumen Endotracheal Intubation: A Prospective, Randomized, Double-Blind, Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124322
Enrollment
Unknown
Registered
2026-05-11
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Postoperative sore throat

Interventions

Treatment group (DR group):Treatment group (DR group): 1 µg/kg dexmedetomidine combined with 40 mg of 1% ropivacaine was administered by oropharyngeal spray under video laryngoscopic guidance before t
Ropivacaine group (R group):Ropivacaine group (R group): 40 mg of 1% ropivacaine was administered by oropharyngeal spray under video laryngoscopic guidance before tracheal intubation, targeting the su
Placebo control group (S group):An equal volume of 0.9% normal saline was administered by oropharyngeal spray under video laryngoscopic guidance before tracheal intubation, targeting the supraglottic,

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years; 2. ASA physical status I–III; 3. Scheduled for elective thoracic surgery requiring left-sided double-lumen endotracheal intubation to achieve one-lung ventilation; 4. Able to communicate sufficiently in Chinese and clearly understand the relevant assessment scales; 5. Willing to participate in this study and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. BMI > 30 kg/m²; 2. Patients with a history of sore throat or hoarseness, recent upper respiratory tract infection, prior tracheostomy, Mallampati classification = 3, known or predicted difficult airway, Cormack–Lehane grade III or IV laryngoscopic view, or more than two intubation attempts; 3. Patients with an operative time longer than 3 hours or who are unable to be extubated postoperatively; 4. Patients with allergy to amide local anesthetics, bradycardia, cardiac conduction block, sick sinus syndrome, severe hepatic or renal insufficiency, uncontrolled hypertension, or long-term use of sedative medications such as benzodiazepines, barbiturates, or other sedative-hypnotic drugs.

Design outcomes

Primary

MeasureTime frame
Incidence of sore throat at 24 hours after extubation;

Secondary

MeasureTime frame
Incidence and severity of sore throat at 1 hour after extubation;Incidence and severity of sore throat at 6 hour after extubation;Incidence and severity of sore throat at 48 hour after extubation; Severity of sore throat at 24 hours after extubation;Incidence and severity of hoarseness at 1 hour after extubation;Incidence and severity of hoarseness at 6 hour after extubation;Incidence and severity of hoarseness at 24 hour after extubation;Incidence and severity of hoarseness at 48 hour after extubation;Cough score during extubation;Hemodynamic variables during intubation and extubation;

Countries

China

Contacts

Public ContactGuiying Yang

The Second Affiliated Hospital of Army Medical University

472151685@qq.com+86 136 9648 6560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026