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

NCT07202624 | Completed Phase 2 DMC

• 1 other identifier: HP-01-R079
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative Sore Throat; Prone Surgery; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• the incidence and severity of POST, hoarseness, cough

  The primary outcome will be the incidence and severity of POST, hoarseness, cough will be assessed for 1st, 6th, 12th and 24th hour after extubation. The assessment will be done by the on-call anesthesiology resident who was blinded of the study group. The severity of POST, hoarseness, and cough will be graded using a 4-point scale (0: no, 1: minimal, 2: moderate, 3: severe) (Table 1) (15). Any patient will develop post-operative sore throat will be given dexamethasone 8 mg IV stat and advised warm normal saline gargles.

  Day 1 postoperative

Secondary Outcomes (1)

• hemodynamic parameters

  Day 1 postoperative

Other Outcomes (1)

• Weight in Kilograms, Height in meters

  Day 1 postoperative

Study Arms (2)

Group A, ETT cuff will be filled with dexmedetomidine (n = 50)

EXPERIMENTAL

ETT cuff will be filled with 4 ml of dexmedetomidine 4 mcg/ml.

Drug: Dexmedetomidine (Precedex)

Group B, ETT cuff will be filled with alkalinized lidocaine (n = 50)

ACTIVE COMPARATOR

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: alkalinized lidocaine

Interventions

Dexmedetomidine (Precedex) DRUG

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

Also known as: Group D

Group A, ETT cuff will be filled with dexmedetomidine (n = 50)

alkalinized lidocaine DRUG

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

Also known as: Group AL

Group B, ETT cuff will be filled with alkalinized lidocaine (n = 50)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 to 75 years
• American Society of Anesthesiologists (ASA) physical status I and II patients
• Either sex
• Undergoing lumbar spine surgery in prone position under general anesthesia with endotracheal intubation.

You may not qualify if:

• Patients with a history of recent respiratory tract infection
• Prior medication with analgesics or corticosteroids.
• Patients who have preoperative sore throat, hoarseness and cough, have a nasogastric tube,
• Patients with Mallampati class \> 2 and who required more than one attempt for tracheal intubation or patients had a duration of tracheal intubation of \< 60 min or \> 300 min and
• Patients not willing to provide their voluntary written informed consent.

Sponsors & Collaborators

• Prince Sultan Military Medical City: lead

Study Sites (1)

Prince Sultan Military Medical City

Riyadh, 12232, Saudi Arabia

Location

Related Publications (2)

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

  PMID: 27158989 BACKGROUND

• Aqil M, Khan MU, Mansoor S, Mansoor S, Khokhar RS, Narejo AS. Incidence and severity of postoperative sore throat: a randomized comparison of Glidescope with Macintosh laryngoscope. BMC Anesthesiol. 2017 Sep 12;17(1):127. doi: 10.1186/s12871-017-0421-4.

  PMID: 28899338 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Muteb AlOtaibi, MD

  Prince Sultan Military Medical City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONSULTANT ANESTHESIA, Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: October 2, 2025
• Study Start: February 10, 2025
• Primary Completion: June 15, 2025
• Study Completion: October 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)