NCT05581485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

October 4, 2022

Last Update Submit

September 5, 2025

Conditions

Endoscopic Laryngeal Surgery

Keywords

LaryngomicrosurgeryNonintubationspontaneous breathingdexmedetomidine

Outcome Measures

Primary Outcomes (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)

    From pre-induction through 15 minutes postoperatively

Secondary Outcomes (5)

  • Arterial Oxygenation (PaO₂)

    From pre-induction through 15 minutes postoperatively

  • Mean Arterial Pressure (MAP)

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

  • Heart rate

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

  • Surgeon stress score

    Immediately after completion of the surgical procedure

  • Arterial pH

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

Study Arms (2)

Dexmedetomidine Infusion Arm for Non-Intubated Laryngeal Surgery Using THRIVE

EXPERIMENTAL

This 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.

Drug: Dexmetedomedine infusion

Superior Laryngeal Nerve Block (SLNB)

ACTIVE COMPARATOR

This 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.

Procedure: Ultrasound-Guided Superior Laryngeal Nerve Block (SLNB)

Interventions

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.

Dexmedetomidine Infusion Arm for Non-Intubated Laryngeal Surgery Using THRIVE
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.

Superior Laryngeal Nerve Block (SLNB)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362, Taiwan

Location

Related Publications (9)

  • 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.

    PMID: 30522856BACKGROUND

  • 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.

    PMID: 28403407BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 28904657BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25478365BACKGROUND

  • 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.

    PMID: 21804794BACKGROUND

  • 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.

    PMID: 19188334BACKGROUND

  • 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.

    PMID: 28203745BACKGROUND

Study Officials

  • Kai Wei Hsieh, physician

    Kaohsiung Veterans General Hospital.

    STUDY DIRECTOR

  • Ting Shou Chang, physician

    Kaohsiung Veterans General Hospital.

    STUDY DIRECTOR

  • Chih Chi Tsai, RA

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Anesthesiology

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 14, 2022

Study Start

November 29, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

TW(1)