Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia

NCT05420649 | Completed

• 1 other identifier: KSVGH20-CT9-09
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.

Conditions

Spontaneous Breathing; Laryngomicrosurgery; Superior Laryngeal Nerve Block

Keywords

Nonintubated; Spontaneous breathing; Laryngomicrosurgery; Superior laryngeal nerve block

Outcome Measures

Primary Outcomes (1)

• PaCO2 after Laryngomicrosurgery

  ABG was measured immediately after the end of LMS

  ABG was measured immediately after the end of LMS

Secondary Outcomes (2)

• pH after Laryngomicrosurgery

  ABG was measured immediately after the end of LMS

• Heart rate (HR)

  during the LMS procedure

Study Arms (3)

Intubated general anesthesia LMS

NO INTERVENTION

Patients received LMS with intubated general anesthesia

Non-intubated LMS with apnea

EXPERIMENTAL

Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.

Procedure: Non-intubated Laryngomicrosurgery

Non-intubated LMS with spontaneous breathing

EXPERIMENTAL

Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.

Procedure: Non-intubated Laryngomicrosurgery

Interventions

Non-intubated Laryngomicrosurgery PROCEDURE

Non-intubated LMS was performed with assistance of Optiflow (HFNO).

Non-intubated LMS with apnea; Non-intubated LMS with spontaneous breathing

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient who needed to undergo LMS.

You may not qualify if:

• Severe airway obstruction.
• Severe airway disease.
• American Society of anesthesiologists (ASA) physical state \> III.
• Pregnancy or body mass index (BMI) ≥ 40 kg/m2.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Related Publications (21)

• 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: 28203745 BACKGROUND

• Montgomery J, Melia L, O'Donnell N, MacKenzie K. Intubation trauma and the head and neck surgeon: issues with a shared airway. J R Soc Med. 2015 Nov;108(11):426-8. doi: 10.1177/0141076815614803. No abstract available.

  PMID: 26609095 BACKGROUND

• 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: 30522856 BACKGROUND

• Catalano G, Robeel RA, Cheney GA, Spurling BC, Catalano MC, Schultz SK, Sanchez DL. Antidepressant Augmentation: A Review of the Literature and a Review of the Pharmacoeconomic Considerations. J Clin Psychopharmacol. 2020 Jul/Aug;40(4):396-400. doi: 10.1097/JCP.0000000000001236.

  PMID: 32639292 BACKGROUND

• Yasar NF, Uylas MU, Badak B, Bilge U, Oner S, Ihtiyar E, Caga T, Pasaoglu E. Can we predict mortality in patients with necrotizing fasciitis using conventional scoring systems? Ulus Travma Acil Cerrahi Derg. 2017 Sep;23(5):383-388. doi: 10.5505/tjtes.2016.19940.

  PMID: 29052823 BACKGROUND

• Booth AWG, Vidhani K, Lee PK, Coman SH, Pelecanos AM, Dimeski G, Sturgess DJ. The Effect of High-Flow Nasal Oxygen on Carbon Dioxide Accumulation in Apneic or Spontaneously Breathing Adults During Airway Surgery: A Randomized-Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):133-141. doi: 10.1213/ANE.0000000000005002.

  PMID: 32618626 BACKGROUND

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

  PMID: 26329355 BACKGROUND

• Williams R, Rankin N, Smith T, Galler D, Seakins P. Relationship between the humidity and temperature of inspired gas and the function of the airway mucosa. Crit Care Med. 1996 Nov;24(11):1920-9. doi: 10.1097/00003246-199611000-00025.

  PMID: 8917046 BACKGROUND

• Bernards CM, Knowlton SL, Schmidt DF, DePaso WJ, Lee MK, McDonald SB, Bains OS. Respiratory and sleep effects of remifentanil in volunteers with moderate obstructive sleep apnea. Anesthesiology. 2009 Jan;110(1):41-9. doi: 10.1097/ALN.0b013e318190b501.

  PMID: 19104169 BACKGROUND

• Stockwell M, Lozanoff S, Lang SA, Nyssen J. Superior laryngeal nerve block: an anatomical study. Clin Anat. 1995;8(2):89-95. doi: 10.1002/ca.980080202.

  PMID: 7712327 BACKGROUND

• Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.

  PMID: 20865885 BACKGROUND

• Pani N, Kumar Rath S. Regional & topical anaesthesia of upper airways. Indian J Anaesth. 2009 Dec;53(6):641-8.

  PMID: 20640090 BACKGROUND

• Menda F, Koner O, Sayin M, Ture H, Imer P, Aykac B. Dexmedetomidine as an adjunct to anesthetic induction to attenuate hemodynamic response to endotracheal intubation in patients undergoing fast-track CABG. Ann Card Anaesth. 2010 Jan-Apr;13(1):16-21. doi: 10.4103/0971-9784.58829.

  PMID: 20075530 BACKGROUND

• Chopra P, Dixit MB, Dang A, Gupta V. Dexmedetomidine provides optimum conditions during awake fiberoptic intubation in simulated cervical spine injury patients. J Anaesthesiol Clin Pharmacol. 2016 Jan-Mar;32(1):54-8. doi: 10.4103/0970-9185.175666.

  PMID: 27006542 BACKGROUND

• Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.

  PMID: 16052125 BACKGROUND

• Funk DJ. Apneic oxygenation: Let's all just take a deep breath. Can J Anaesth. 2017 Apr;64(4):358-360. doi: 10.1007/s12630-016-0801-0. Epub 2016 Dec 22. No abstract available.

  PMID: 28008564 BACKGROUND

• Handy JM, Soni N. Physiological effects of hyperchloraemia and acidosis. Br J Anaesth. 2008 Aug;101(2):141-50. doi: 10.1093/bja/aen148. Epub 2008 Jun 4.

  PMID: 18534973 BACKGROUND

• Kiely DG, Cargill RI, Lipworth BJ. Effects of hypercapnia on hemodynamic, inotropic, lusitropic, and electrophysiologic indices in humans. Chest. 1996 May;109(5):1215-21. doi: 10.1378/chest.109.5.1215.

  PMID: 8625670 BACKGROUND

• Onwochei D, El-Boghdadly K, Oakley R, Ahmad I. Intra-oral ignition of monopolar diathermy during transnasal humidified rapid-insufflation ventilatory exchange (THRIVE). Anaesthesia. 2017 Jun;72(6):781-783. doi: 10.1111/anae.13873. Epub 2017 Mar 20.

  PMID: 28321836 BACKGROUND

• Akhtar N, Ansar F, Baig MS, Abbas A. Airway fires during surgery: Management and prevention. J Anaesthesiol Clin Pharmacol. 2016 Jan-Mar;32(1):109-11. doi: 10.4103/0970-9185.175710.

  PMID: 27006554 BACKGROUND

• Kuo YT, Chang TS, Tsai CC, Chang HC, Chia YY. Optimizing nonintubated laryngeal microsurgery: The effectiveness and safety of superior laryngeal nerve block with high-flow nasal oxygen-A prospective cohort study. J Chin Med Assoc. 2024 Mar 1;87(3):334-339. doi: 10.1097/JCMA.0000000000001057. Epub 2024 Jan 30.

  PMID: 38305707 DERIVED

Study Officials

• Yuan Yi Chia, Director

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Yu Ting Kuo, 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

• Li-Ya Tseng, physician

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

• Pei-Wen Shen, physician

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: June 15, 2022
• Study Start: October 20, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

TW (1)