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Trial record 37 of 179 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT02065635
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

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.

Condition or disease Intervention/treatment Phase
Anesthesia Exhaled Nitric Oxide Eosinophil Blood Count Procedure: maintenance with sevoflurane Procedure: maintenance with propofol Not Applicable

Detailed Description:
  • Nitric oxide (NO) is a free radical in gas state which plays an important role in a variety of processes relevant to respiratory physiology. NO is produced by several cellular types (epithelial, endothelial, neuronic, inflammatory cells) (Gaston B, et al, 1994), it represents a means of detecting airway hyperresponsiveness and appears to have a strong correlation with the eosinophilic infiltration of the airway (Warke TJ, et al, 2002). Patients who suffered bronchospasm or laryngospasm intraoperatively or postoperatively showed higher levels of exhaled NO (Saraiva-Romanholo BM, et al, 2009).
  • Propofol modifies NO production by stimulating the constitutive synthesis of NO and by inhibiting the inducible production of NO (González-Correa JA, et al, 2008). It seems to exert protective effects on acute lung injury in experimental models (Chu CH, et al, 2007; Chen HJ, et al, 2008) and possibly reduces exhaled NO (Fijałkowska A, et al, 2012). There is also evidence that some intravenous anesthetic agents can influence chemotaxis of eosinophils in vitro (Krumholz W, et al, 1999)
  • 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.
  • Patients with ASA score I-III who undergo thyroidectomy under general anaesthesia will participate in this study. Thyroidectomy has been chosen for the following reasons: a) there will be consistency in both the surgeon and the type of surgery and as a result manipulations and surgical stress will be similar for all patients and b) abdominal walls are not manipulated at all during thyroidectomy and therefore postoperative measurement of exhaled NO will be easier and painless for patients.
  • Patients will be randomized to one of two groups: one group with general anesthesia maintenance based on an intravenous agent (propofol) and a second group with general anesthesia maintenance based on an inhalational agent (sevoflurane).
  • When patients arrive in the operating room, standard monitoring will be applied and exhaled NO will be measured immediately before induction with the NObreath® device ( Antus B, et al, 2010, Pisi R, et al, 2010) and a blood sample will be taken for eosinophil count measurement.
  • During the patients' stay in the PACU and when Aldrete score is ≥8, exhaled NO will be measured again and a second blood sample will be taken. Exhaled NO will be measured again 24 hours postoperatively.
  • The clinical implications of this study lie in the fact that it may provide further information on the effects of anesthetics (intravenous and inhalational) on the physiology and pathophysiology of the respiratory system. In addition, new evidence may come to light about the relationship between intravenous and inhalational agents and NO production.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigation of Changes in the Levels of Exhaled NO and Eosinophil Blood Count in Patients Undergoing Thyroidectomy by Two Different Methods of General Anesthesia Maintenance
Study Start Date : February 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: maintenance with sevoflurane
in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane
Procedure: maintenance with sevoflurane
in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane

Active Comparator: maintenance with propofol
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
Procedure: maintenance with propofol
in patients allocated to the propofol group, general anesthesia will be maintained with propofol




Primary Outcome Measures :
  1. change of exhaled nitric oxide from preoperative status to immediate postoperative status [ Time Frame: preoperatively, immediately postoperatively ]

Secondary Outcome Measures :
  1. change of exhaled nitric oxide from preoperative status to 24 hours postoperatively [ Time Frame: preoperatively, 24 hours postoperatively ]
  2. change of eosinophil blood count from preoperative status to immediate postoperative status [ Time Frame: preoperatively, immediately postoperatively ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065635


Contacts
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Contact: Kassiani Theodoraki, PhD, DEAA #306974634162 ktheodoraki@hotmail.com
Contact: Artemis Vekrakou, MD #306944218547 artemis_psarrou@hotmail.com

Locations
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Greece
Aretaieion University Hospital Recruiting
Athens, Greece, 115 28
Contact: Kassiani Theodoraki, PhD, DEAA    #306974634162    ktheodoraki@hotmail.com   
Contact: Artemis Vekrakou, MD    #306944218547    artemis_psarrou@hotmail.com   
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DEAA Aretaieion University Hospital
Principal Investigator: Artemis Vekrakou, MD Aretaieion University Hospital
Study Chair: Eriphylli Argyra, PhD Aretaieion University Hospital

Additional Information:
Publications:

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Responsible Party: Dr Kassiani Theodoraki, Associate Professor in Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT02065635     History of Changes
Other Study ID Numbers: NO-Artemis
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation