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Endoscopic Laryngeal SurgeryNCT05581485

Dex vs SLNB in Spontaneous Breathing Via THRIVE for Laryngeal Surgery

A study testing Dexmetedomedine infusion and Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB) in people with Endoscopic Laryngeal Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Endoscopic Laryngeal Surgery
What is being tested?
Dexmetedomedine infusion and Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTaiwan
Study dates
29 Nov 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Kaohsiung Veterans General Hospital

    Kaohsiung, Taiwan, 81362

Other trials in Taiwan

About this study

Official 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

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.

Read the 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.

Being tested
Dexmetedomedine infusion, Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB)
Keywords
Laryngomicrosurgery, Nonintubation, spontaneous breathing, dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmetedomedine infusionDrug

    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 or surgery

    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.

Study groups in NCT05581485
Study groupRoleWhat they receive
Dexmedetomidine Infusion Arm for Non-Intubated Laryngeal Surgery Using THRIVEExperimentalThis arm involves patients undergoing endoscopic laryngeal surgery under non-intubated general anesthesia with spontaneous breathing, supported by transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). Patients receive an intravenous loading dose of dexmedetomidine (1 µg/kg over 10 minutes), followed by a continuous infusion (1 µg/kg/h) for sedation and analgesia. No regional nerve blocks are performed in this arm. Supplemental propofol is titrated via target-controlled infusion (TCI) to maintain BIS levels between 40-60. Topical 10% lidocaine is applied to the airway before insertion of the laryngoscope. Intraoperative fentanyl may be given as needed based on hemodynamic responses.
Receives: Drug: Dexmetedomedine infusion
Superior Laryngeal Nerve Block (SLNB)Active comparatorThis arm includes patients undergoing non-intubated endoscopic laryngeal surgery with spontaneous breathing, supported by transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). After induction with propofol (via TCI) and standard premedication, bilateral ultrasound-guided superior laryngeal nerve blocks are performed using 5 mL of 1% lidocaine on each side for regional analgesia. No dexmedetomidine is administered in this group. Anesthesia is maintained with propofol titrated to a BIS range of 40-60. Additional fentanyl may be administered intraoperatively as needed to control sympathetic responses. Topical 10% lidocaine is applied to the airway prior to laryngoscope insertion.
Receives: Procedure: Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative PaCO2

    Arterial 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)

    Measured: From pre-induction through 15 minutes postoperatively

Secondary outcomes (5)
  1. Arterial Oxygenation (PaO₂)

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

    Measured: From pre-induction through 15 minutes postoperatively

  2. Mean Arterial Pressure (MAP)

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

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

  3. Heart rate

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

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

  4. Surgeon stress score

    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

    1. = Minimal stress
    2. = Mild stress
    3. = Moderate stress
    4. = High stress
    5. = Extremely high stress

    Measured: Immediately after completion of the surgical procedure

  5. Arterial pH

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start29 Nov 2022
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581485
Sponsor's protocol ID
KSVGH22-CT8-38
Status last verified
Sep 2025
First submitted
4 Oct 2022
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang SH, Wu CY, Tseng WH, Cherng WY, Hsiao TY, Cheng YJ, Chan KC. Nonintubated laryngomicrosurgery with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange: A case series. J Formos Med Assoc. 2019 Jul;118(7):1138-1143. doi: 10.1016/j.jfma.2018.11.009. Epub 2018 Dec 3.

    PubMed 30522856
  • Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

    PubMed 28403407
  • W.Abd El Megid, W., & Nassar, A. M. (2009). The analgesic and sedative properties of dexmedetomidine infusion after uvulopalatopharyngoplasty. The Egyptian Journal of Hospital Medicine, 36(1), 421-433.

  • Gemechu BM, Gebremedhn EG, Melkie TB. Risk factors for postoperative throat pain after general anaesthesia with endotracheal intubation at the University of Gondar Teaching Hospital, Northwest Ethiopia, 2014. Pan Afr Med J. 2017 Jun 16;27:127. doi: 10.11604/pamj.2017.27.127.10566. eCollection 2017.

    PubMed 28904657
  • Ahmed A, Saad D, Youness AR. Superior laryngeal nerve block as an adjuvant to General Anesthesia during endoscopic laryngeal surgeries. Egyptian Journal of Anaesthesia 2015;31:167-74.

  • Naaz S, Ozair E. Dexmedetomidine in current anaesthesia practice- a review. J Clin Diagn Res. 2014 Oct;8(10):GE01-4. doi: 10.7860/JCDR/2014/9624.4946. Epub 2014 Oct 20.

    PubMed 25478365
  • Abdelmageed WM, Elquesny KM, Shabana RI, Abushama HM, Nassar AM. Analgesic properties of a dexmedetomidine infusion after uvulopalatopharyngoplasty in patients with obstructive sleep apnea. Saudi J Anaesth. 2011 Apr;5(2):150-6. doi: 10.4103/1658-354X.82782.

    PubMed 21804794
  • Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.

    PubMed 19188334
  • Booth AWG, Vidhani K, Lee PK, Thomsett CM. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth. 2017 Mar 1;118(3):444-451. doi: 10.1093/bja/aew468.

    PubMed 28203745

Questions about this trial

What is this clinical trial studying?

A study testing Dexmetedomedine infusion and Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB) in people with Endoscopic Laryngeal Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative PaCO2 (time frame: From pre-induction through 15 minutes postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581485, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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