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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 (PaCOâ‚‚), 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:
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 (PaCOâ‚‚) 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 (PaOâ‚‚, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative PaCO2 | Arterial blood gas was collected and analyzed at three time points to assess changes in PaCOâ‚‚ as the primary outcome:
| From pre-induction through 15 minutes postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Oxygenation (PaOâ‚‚) | Arterial partial pressure of oxygen (PaOâ‚‚) measured via ABG at three time points: preoxygenation baseline, immediately post-surgery, and 15 minutes after PACU arrival. | From pre-induction through 15 minutes postoperatively |
| Mean Arterial Pressure (MAP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | 81362 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30522856 | Result | 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. | |
| 28403407 | Result | 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. |
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| 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. |
|
Monitoring of mean arterial pressure at defined intervals to evaluate cardiovascular responses to anesthetic strategy. |
| Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU |
| Heart rate | Assessment of heart rate variability across the surgical timeline to monitor hemodynamic stability. | Preoperative, intraoperative (every 5 minutes), and 15 minutes postoperatively in the PACU |
| 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
| Immediately after completion of the surgical procedure |
| Arterial pH | Arterial pH will be measured at three time points:
| Baseline, end of surgery, PACU (15 minutes post-arrival) |
| Result | 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. |
| 28904657 | Result | 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. |
| Result | 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. |
| 25478365 | Result | 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. |
| 21804794 | Result | 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. |
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| 19188334 | Result | 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. |
| 28203745 | Result | 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. |