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The Effectiveness of Intracuff Dexmedetomidine in Preventing Postoperative Sore Throat Following Prone Surgery

NCT07202624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-11-20

No results posted yet for this study

Summary

Postoperative sore throat (POST) is a common consequence of tracheal intubation, affecting 30% to 65% of patients, while hoarseness occurs in approximately 16% to 55% of cases. POST is undesirable as it negatively impacts the surgical experience, patient satisfaction, and daily activities even after discharge. It can result from factors such as vocal cord damage, nerve compression, blood loss, and injury to mucosal cells due to airway secretions and prolonged anesthesia.

Recent studies have identified several contributors to POST, including the shape and size of the tracheal tube, cuff pressure, duration of tube placement, and the use of inhalation anesthesia. Changing a patient's position from supine to prone can affect the cuff pressure and displacement of the endotracheal tube (ETT), which may influence the incidence of POST, hoarseness, and cough. Improper positioning can also strain neck muscles, putting pressure on the vocal cords and leading to hoarseness.

To reduce POST incidence, selecting the appropriate tracheal tube size is crucial, with recommended sizes of 6.0 to 7.5 mm for females and 7.0 to 8.0 mm for males. Maintaining cuff pressure between 20-25 mmHg is associated with a lower incidence of POST, as excessive pressure can cause mucosal trauma. Additional strategies include using video laryngoscopy for intubation, administering topical non-steroidal anti-inflammatory drugs (NSAIDs), and using steroids during surgery.

Recent research is exploring the effectiveness of intracuff saline and lignocaine for preventing coughing and POST. Increasing the alkalinity of local anesthetics with sodium bicarbonate can enhance their efficacy, improving diffusion through the ETT cuff. Dexmedetomidine, a selective alpha-2 receptor agonist, has shown promise in reducing cough rates and postoperative pain. Notably, a single dose of gargled dexmedetomidine (0.5 µg/kg) has demonstrated effects comparable to intravenous administration, and intratracheal dexmedetomidine has proven more effective than lidocaine in reducing cough reflex and facilitating smooth extubation.

Conditions

  • Sore Throat

Interventions

DRUG

alkalinized lidocaine

lidocaine 2%, 2 ml will be initially injected into the cuff, and then a supplementary volume of 2 ml of sodium bicarbonate (NaHCO3) 8.4% will be added

DRUG

Dexmedetomidine (Precedex)

The ETT cuff will be filled with 4 mL of dexmedetomidine 4 mcg/mL

Sponsors & Collaborators

  • Prince Sultan Military Medical City

    lead OTHER

Principal Investigators

  • Muteb AlOtaibi, MD · Prince Sultan Military Medical City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-06-15
Completion
2025-10-01

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202624 on ClinicalTrials.gov