AnesthesiaNCT02065635

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

A study testing maintenance with sevoflurane and maintenance with propofol in people with Anesthesia and Exhaled Nitric Oxide, run by Aretaieion University Hospital at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Anesthesia, Exhaled Nitric Oxide, Eosinophil Blood Count
What is being tested?: maintenance with sevoflurane and maintenance with propofol
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGreece
Study dates: May 2014to Apr 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Aretaieion University Hospital
Athens, 115 28

Other trials in Greece

About this study

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

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.

Read the 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.

Conditions: Anesthesia, Exhaled Nitric Oxide, Eosinophil Blood Count
Being tested: maintenance with sevoflurane, maintenance with propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

maintenance with sevofluraneProcedure or surgery
in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane
maintenance with propofolProcedure or surgery
in patients allocated to the propofol group, general anesthesia will be maintained with propofol

Study groups in NCT02065635
Study group	Role	What they receive
maintenance with sevoflurane	Experimental	in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane Receives: Procedure: maintenance with sevoflurane
maintenance with propofol	Active comparator	in patients allocated to the propofol group, general anesthesia will be maintained with propofol Receives: Procedure: maintenance with propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

change of exhaled nitric oxide from preoperative status to immediate postoperative status
Measured: preoperatively, immediately postoperatively

Secondary outcomes (2)

change of exhaled nitric oxide from preoperative status to 24 hours postoperatively
Measured: preoperatively, 24 hours postoperatively
change of eosinophil blood count from preoperative status to immediate postoperative status
Measured: preoperatively, immediately postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Apr 2018

First posted19 Feb 2014 (estimated)
Study startMay 2014
Primary completionApr 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02065635
Sponsor's protocol ID: NO-Artemis
Status last verified: Jan 2022
First submitted: 15 Feb 2014
Last updated: 1 Feb 2022
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 7508323
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.
PubMed 11978911
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.
PubMed 19142544
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.
PubMed 18064439
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.
PubMed 16713316
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.
PubMed 18379248
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.
PubMed 10618953
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.
PubMed 20594818
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.
PubMed 20670207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02065635
Acronym / sponsor ID: NO-Artemis
Conditions: Anesthesia, Exhaled Nitric Oxide, Eosinophil Blood Count
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aretaieion University HospitalUniversity, hospital or other
Study start: May 2014
Primary completion: Apr 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 19 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
maintenance with sevoflurane	Experimental	Procedure: maintenance with sevofluranein patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane
maintenance with propofol	Active comparator	Procedure: maintenance with propofolin patients allocated to the propofol group, general anesthesia will be maintained with propofol

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
maintenance with sevofluranein patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane	Procedure or surgery	maintenance with sevoflurane
maintenance with propofolin patients allocated to the propofol group, general anesthesia will be maintained with propofol	Procedure or surgery	maintenance with propofol

Primary outcome

change of exhaled nitric oxide from preoperative status to immediate postoperative status
Time frame: preoperatively, immediately postoperatively

2 secondary outcomes

change of exhaled nitric oxide from preoperative status to 24 hours postoperatively
Time frame: preoperatively, 24 hours postoperatively
change of eosinophil blood count from preoperative status to immediate postoperative status
Time frame: preoperatively, immediately postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Background: PubMed 7508323Gaston 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.
Background: PubMed 11978911Warke 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.
Background: PubMed 19142544Saraiva-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.
Background: PubMed 18064439Gonzalez-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.
Background: PubMed 16713316Chu 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.
Background: PubMed 18379248Chen 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.
Background: PubMed 10618953Krumholz 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.
Background: PubMed 20594818Antus 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.
Background: PubMed 20670207Pisi 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.
video about the use of NOBreath deviceLink provided by the sponsor.
information about NOBreath deviceLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kassiani Theodoraki, PhD, DEAA principal investigator

Aretaieion University Hospital

Artemis Vekrakou, MD principal investigator

Aretaieion University Hospital

Eriphylli Argyra, PhD study chair

Aretaieion University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing maintenance with sevoflurane and maintenance with propofol in people with Anesthesia and Exhaled Nitric Oxide, run by Aretaieion University Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of exhaled nitric oxide from preoperative status to immediate postoperative status (time frame: preoperatively, immediately postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02065635, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.