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Completed

NCT Number: NCT05581485

Dex vs SLNB in Spontaneous Breathing Via THRIVE for Laryngeal Surgery

This prospective, randomized controlled trial evaluated the efficacy and safety of two anesthetic strategies-dexmedetomidine infusion and ultrasound-guided superior laryngeal nerve block (SLNB)-in patients undergoing non-intubated endoscopic laryngeal surgery under spontaneous breathing supported by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The primary outcome was the arterial partial pressure of carbon dioxide (PaCO₂), measured at three time points: before oxygenation, at the end of surgery, and in the post-anesthesia care unit (PACU). Secondary outcomes included other arterial blood gas parameters, hemodynamic variables, and surgeon satisfaction scores.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

About this study

Detailed Description:

This prospective, single-center randomized controlled trial was conducted to compare two anesthetic strategies-Dexmedetomidine infusion and ultrasound-guided bilateral superior laryngeal nerve block (SLNB)-for non-intubated endoscopic laryngeal surgery performed under spontaneous respiration with high-flow nasal oxygenation (THRIVE). The study was carried out at Kaohsiung Veterans General Hospital, Taiwan.

Patients aged 20 to 80 years scheduled for elective microlaryngeal surgery were enrolled and randomly assigned to either the Dexmedetomidine (Dex) group or the SLNB group. Both groups received total intravenous anesthesia (TIVA) with propofol and oxygenation via transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) to facilitate tubeless anesthesia. The Dex group received a loading dose of Dexmedetomidine (1 µg/kg over 10 minutes) followed by continuous infusion (1 µg/kg/h), while the SLNB group underwent bilateral ultrasound-guided nerve blocks with 1% lidocaine.

The primary outcome was the arterial partial pressure of carbon dioxide (PaCO₂) measured at three time points: before oxygenation (baseline), at the end of surgery, and 15 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes included arterial blood gas parameters (PaO₂, pH), intraoperative hemodynamic variables (HR, SBP, DBP, MAP), and surgeon satisfaction scores.

The goal of this study was to evaluate whether Dexmedetomidine, which offers both sedative and analgesic properties while preserving spontaneous breathing, could serve as a viable alternative to regional nerve block in the context of shared-airway surgery. Particular attention was given to the risk of carbon dioxide accumulation and respiratory acidosis associated with Dexmedetomidine.

This trial provides important insights into the safety and efficacy of two distinct anesthetic modalities for performing non-intubated endoscopic laryngeal surgery and contributes to the ongoing optimization of airway management strategies in tubeless anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects are between 20-80 years old.
  • Patients undergoing endoscopic laryngeal surgery.
  • Anesthesiologists rated ASA as between I and III.

Exclusion criteria

  • Having drug dependence and drinking habits.
  • Abnormal heart, liver and kidney function.
  • Allergic reactions to narcotic drugs.
  • Emergency surgery.
  • pregnancy.
  • Refuse to participate.
  • BMI ≥ 35 kg/m2.

Treatment and study plan

Dexmetedomedine infusion

Drug

Patients received a loading dose of dexmedetomidine at 1 µg/kg over 10 minutes, followed by a continuous infusion at 1 µg/kg/h throughout the procedure. This regimen was combined with TIVA (propofol) and THRIVE to support spontaneous breathing during endoscopic laryngeal surgery.

Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB)

Procedure

Following anesthesia induction, patients received bilateral ultrasound-guided superior laryngeal nerve blocks using 5 mL of 1% lidocaine per side. This intervention was combined with total intravenous anesthesia (TIVA) using propofol and high-flow nasal oxygenation (THRIVE) to maintain spontaneous respiration during endoscopic laryngeal surgery.

Primary outcomes

  1. Perioperative PaCO2

    Time frame: From pre-induction through 15 minutes postoperatively

    Arterial blood gas was collected and analyzed at three time points to assess changes in PaCO₂ as the primary outcome:

    • At baseline (after preoxygenation, prior to induction)
    • Immediately after completion of endoscopic laryngeal surgery
    • Fifteen minutes after arrival in the post-anesthesia care unit (PACU)

Secondary outcomes

  1. Arterial Oxygenation (PaO₂)

    Time frame: From pre-induction through 15 minutes postoperatively

    Arterial partial pressure of oxygen (PaO₂) measured via ABG at three time points: preoxygenation baseline, immediately post-surgery, and 15 minutes after PACU arrival.

  2. Mean Arterial Pressure (MAP)

    Time frame: Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU

    Monitoring of mean arterial pressure at defined intervals to evaluate cardiovascular responses to anesthetic strategy.

  3. Heart rate

    Time frame: Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU

    Assessment of heart rate variability across the surgical timeline to monitor hemodynamic stability.

  4. Surgeon stress score

    Time frame: Immediately after completion of the surgical procedure

    Subjective evaluation of the surgeon's intraoperative stress level, based on surgical field visibility, patient movement, and anesthetic stability. The score is rated on a 6-point scale from 0 to 5, where:

    0 = No stress

    • = Minimal stress
    • = Mild stress
    • = Moderate stress
    • = High stress
    • = Extremely high stress
  5. Arterial pH

    Time frame: Baseline, end of surgery, PACU (15 minutes post-arrival)

    Arterial pH will be measured at three time points:

    • preoxygenation (baseline),
    • immediately after the end of endoscopic laryngeal surgery,
    • 15 minutes after arrival in the post-anesthesia care unit (PACU).

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Comparison of Dexmedetomidine and Superior Laryngeal Nerve Block for Non-Intubated Endoscopic Laryngeal Surgery With Spontaneous Breathing Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.