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Dex vs SLNB in Spontaneous Breathing Via THRIVE for Laryngeal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05581485
Enrollment
46
Registered
2022-10-14
Start date
2022-11-29
Completion date
2025-07-31
Last updated
2025-09-08

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

Conditions

Endoscopic Laryngeal Surgery

Keywords

Laryngomicrosurgery, Nonintubation, spontaneous breathing, dexmedetomidine

Brief summary

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.

Detailed description

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.

Interventions

DRUGDexmetedomedine infusion

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.

PROCEDUREUltrasound-Guided Superior Laryngeal Nerve Block (SLNB)

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.

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative PaCO2From pre-induction through 15 minutes postoperativelyArterial blood gas was collected and analyzed at three time points to assess changes in PaCO₂ as the primary outcome: 1. At baseline (after preoxygenation, prior to induction) 2. Immediately after completion of endoscopic laryngeal surgery 3. Fifteen minutes after arrival in the post-anesthesia care unit (PACU)

Secondary

MeasureTime frameDescription
Arterial Oxygenation (PaO₂)From pre-induction through 15 minutes postoperativelyArterial partial pressure of oxygen (PaO₂) measured via ABG at three time points: preoxygenation baseline, immediately post-surgery, and 15 minutes after PACU arrival.
Mean Arterial Pressure (MAP)Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACUMonitoring of mean arterial pressure at defined intervals to evaluate cardiovascular responses to anesthetic strategy.
Heart ratePreoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACUAssessment of heart rate variability across the surgical timeline to monitor hemodynamic stability.
Surgeon stress scoreImmediately after completion of the surgical procedureSubjective 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 1. = Minimal stress 2. = Mild stress 3. = Moderate stress 4. = High stress 5. = Extremely high stress
Arterial pHBaseline, end of surgery, PACU (15 minutes post-arrival)Arterial pH will be measured at three time points: 1. preoxygenation (baseline), 2. immediately after the end of endoscopic laryngeal surgery, 3. 15 minutes after arrival in the post-anesthesia care unit (PACU).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026