Effect of Type of General Anesthesia Maintenance on Exhaled Nitric Oxide and Eosinophil Blood Count

NCT02065635 | Completed DMC

• 1 other identifier: NO-Artemis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• Nitric oxide (NO) is a free radical in gas state which plays an important role in a variety of processes relevant to respiratory physiology. It represents a means of detecting airway hyperresponsiveness and appears to have a strong correlation with the eosinophilic infiltration of the airway. Patients who suffered bronchospasm or laryngospasm intraoperatively or postoperatively showed higher levels of exhaled NO.
• Propofol modifies NO production by stimulating the constitutive synthesis of NO and by inhibiting the inducible production of NO. It seems to exert protective effects on acute lung injury (ALI) in experimental models and it can possibly reduce exhaled NO. There is also evidence that some intravenous anesthetic agents can influence chemotaxis of eosinophils in vitro.
• Variation of exhaled NO and eosinophils in surgical patients undergoing anesthesia has not been studied before. Therefore, the aim of this study will be to investigate the differential impact of maintenance of general anesthesia with propofol versus maintenance with sevoflurane on exhaled NO and eosinophil blood count.

Conditions

Anesthesia; Exhaled Nitric Oxide; Eosinophil Blood Count

Outcome Measures

Primary Outcomes (1)

• change of exhaled nitric oxide from preoperative status to immediate postoperative status

  preoperatively, immediately postoperatively

Secondary Outcomes (2)

• change of exhaled nitric oxide from preoperative status to 24 hours postoperatively

  preoperatively, 24 hours postoperatively

• change of eosinophil blood count from preoperative status to immediate postoperative status

  preoperatively, immediately postoperatively

Study Arms (2)

maintenance with sevoflurane

EXPERIMENTAL

in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane

Procedure: maintenance with sevoflurane

maintenance with propofol

ACTIVE COMPARATOR

in patients allocated to the propofol group, general anesthesia will be maintained with propofol

Procedure: maintenance with propofol

Interventions

maintenance with sevoflurane PROCEDURE

in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane

maintenance with sevoflurane

maintenance with propofol PROCEDURE

in patients allocated to the propofol group, general anesthesia will be maintained with propofol

maintenance with propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for thyroidectomy

You may not qualify if:

• patients with history of airway hyperreactivity (asthma, bronchitis)
• patients with history of allergy

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

Location

Related Publications (9)

• Gaston B, Drazen JM, Loscalzo J, Stamler JS. The biology of nitrogen oxides in the airways. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):538-51. doi: 10.1164/ajrccm.149.2.7508323.

  PMID: 7508323 BACKGROUND

• Warke TJ, Fitch PS, Brown V, Taylor R, Lyons JD, Ennis M, Shields MD. Exhaled nitric oxide correlates with airway eosinophils in childhood asthma. Thorax. 2002 May;57(5):383-7. doi: 10.1136/thorax.57.5.383.

  PMID: 11978911 BACKGROUND

• Saraiva-Romanholo BM, Machado FS, Almeida FM, Nunes Mdo P, Martins MA, Vieira JE. Non-asthmatic patients show increased exhaled nitric oxide concentrations. Clinics (Sao Paulo). 2009;64(1):5-10. doi: 10.1590/s1807-59322009000100002.

  PMID: 19142544 BACKGROUND

• Gonzalez-Correa JA, Cruz-Andreotti E, Arrebola MM, Lopez-Villodres JA, Jodar M, De La Cruz JP. Effects of propofol on the leukocyte nitric oxide pathway: in vitro and ex vivo studies in surgical patients. Naunyn Schmiedebergs Arch Pharmacol. 2008 Jan;376(5):331-9. doi: 10.1007/s00210-007-0220-4. Epub 2007 Dec 7.

  PMID: 18064439 BACKGROUND

• Chu CH, David Liu D, Hsu YH, Lee KC, Chen HI. Propofol exerts protective effects on the acute lung injury induced by endotoxin in rats. Pulm Pharmacol Ther. 2007;20(5):503-12. doi: 10.1016/j.pupt.2006.03.006. Epub 2006 Apr 21.

  PMID: 16713316 BACKGROUND

• Chen HI, Hsieh NK, Kao SJ, Su CF. Protective effects of propofol on acute lung injury induced by oleic acid in conscious rats. Crit Care Med. 2008 Apr;36(4):1214-21. doi: 10.1097/CCM.0b013e31816a0607.

  PMID: 18379248 BACKGROUND

• Krumholz W, Abdulle O, Knecht J, Hempelmann G. Effects of i.v. anaesthetic agents on the chemotaxis of eosinophils in vitro. Br J Anaesth. 1999 Aug;83(2):333-5. doi: 10.1093/bja/83.2.333.

  PMID: 10618953 BACKGROUND

• Antus B, Horvath I, Barta I. Assessment of exhaled nitric oxide by a new hand-held device. Respir Med. 2010 Sep;104(9):1377-80. doi: 10.1016/j.rmed.2010.06.005. Epub 2010 Jul 2.

  PMID: 20594818 BACKGROUND

• Pisi R, Aiello M, Tzani P, Marangio E, Olivieri D, Chetta A. Measurement of fractional exhaled nitric oxide by a new portable device: comparison with the standard technique. J Asthma. 2010 Sep;47(7):805-9. doi: 10.3109/02770903.2010.485667.

  PMID: 20670207 BACKGROUND

Related Links

• video about the use of NOBreath device
• information about NOBreath device

MeSH Terms

Interventions

Maintenance; Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Kassiani Theodoraki, PhD, DEAA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

• Artemis Vekrakou, MD

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

• Eriphylli Argyra, PhD

  Aretaieion University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 19, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

GR (1)