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Oxidative Stress Related to 2 Different Oxygen Concentrations During General Anesthesia. Clinical Trial.

NCT ID: NCT02619214

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-06-30

Brief Summary

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Clinical trial controlled randomized of parallels groups. The study is designed to look for differences in the oxidative stress level among healthy patients receiving 2 different oxygen concentrations: 30% and 60% during general anesthesia. Once the patient has been informed, the affirmative agreement has been obtained and inclusion and exclusion criteria verified the patients are randomized to 30% or 60% oxygen concentration. In the operating room while placing the intravenous line, a sample blood is obtained. General anesthesia is induced and maintained with sevoflurane. After Anesthesia induction the anesthesia machine is fixed in order to provide the oxygen concentration according to the randomization. One hour later a second venous sample is obtained. Samples are stored in cold conditions until their analysis in the laboratories of the biology faculty - Barcelona University.

Detailed Description

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Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxygen 30%

Patient receives 1 hour of general anesthesia with a 30% oxygen concentration.

Group Type EXPERIMENTAL

30% of oxygen concentration.

Intervention Type DRUG

30% oxygen concentration during one hour of general anesthesia.

Oxygen 60%

Patient receives 1 hour of general anesthesia with a 60% oxygen concentration.

Group Type EXPERIMENTAL

60% of oxygen concentration.

Intervention Type DRUG

60% oxygen concentration during one hour of general anesthesia.

Interventions

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30% of oxygen concentration.

30% oxygen concentration during one hour of general anesthesia.

Intervention Type DRUG

60% of oxygen concentration.

60% oxygen concentration during one hour of general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective surgery, under general anesthesia.
* ASA 1 - 2
* Orl surgery, reconstructive surgery, neck surgery, abdominal wall surgery.

Exclusion Criteria

* Smoking Habit
* Pregnancy
* No compensated disease.
* ASA 3 or Higher.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Barcelona

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Castrillon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist.

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Sebastian Castrillon, M.D

Role: CONTACT

[email protected]
00 34 935537541

Facility Contacts

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Sebastian Castrillon, M.D.

Role: primary

[email protected]
00(34) 935 537 541

Nadia Llavero

Role: backup

[email protected]
(0034) 93 553 76 35 ext. 7635

References

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Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.

Reference Type RESULT
PMID: 11089981 (View on PubMed)

Phillips M, Cataneo RN, Greenberg J, Grodman R, Gunawardena R, Naidu A. Effect of oxygen on breath markers of oxidative stress. Eur Respir J. 2003 Jan;21(1):48-51. doi: 10.1183/09031936.02.00053402.

Reference Type RESULT
PMID: 12570108 (View on PubMed)

Loiseaux-Meunier MN, Bedu M, Gentou C, Pepin D, Coudert J, Caillaud D. Oxygen toxicity: simultaneous measure of pentane and malondialdehyde in humans exposed to hyperoxia. Biomed Pharmacother. 2001 Apr;55(3):163-9. doi: 10.1016/s0753-3322(01)00042-7.

Reference Type RESULT
PMID: 11325214 (View on PubMed)

Winter PM, Smith G. The toxicity of oxygen. Anesthesiology. 1972 Aug;37(2):210-41. doi: 10.1097/00000542-197208000-00010. No abstract available.

Reference Type RESULT
PMID: 4559456 (View on PubMed)

Morita S, Snider MT, Inada Y. Increased N-pentane excretion in humans: a consequence of pulmonary oxygen exposure. Anesthesiology. 1986 Jun;64(6):730-3. doi: 10.1097/00000542-198606000-00009.

Reference Type RESULT
PMID: 3717636 (View on PubMed)

Griendling KK, FitzGerald GA. Oxidative stress and cardiovascular injury: Part I: basic mechanisms and in vivo monitoring of ROS. Circulation. 2003 Oct 21;108(16):1912-6. doi: 10.1161/01.CIR.0000093660.86242.BB. No abstract available.

Reference Type RESULT
PMID: 14568884 (View on PubMed)

Galley HF. Oxidative stress and mitochondrial dysfunction in sepsis. Br J Anaesth. 2011 Jul;107(1):57-64. doi: 10.1093/bja/aer093. Epub 2011 May 19.

Reference Type RESULT
PMID: 21596843 (View on PubMed)

Alonso de Vega JM, Diaz J, Serrano E, Carbonell LF. Plasma redox status relates to severity in critically ill patients. Crit Care Med. 2000 Jun;28(6):1812-4. doi: 10.1097/00003246-200006000-00021.

Reference Type RESULT
PMID: 10890625 (View on PubMed)

Alonso de Vega JM, Diaz J, Serrano E, Carbonell LF. Oxidative stress in critically ill patients with systemic inflammatory response syndrome. Crit Care Med. 2002 Aug;30(8):1782-6. doi: 10.1097/00003246-200208000-00018.

Reference Type RESULT
PMID: 12163793 (View on PubMed)

Khaw KS, Wang CC, Ngan Kee WD, Pang CP, Rogers MS. Effects of high inspired oxygen fraction during elective caesarean section under spinal anaesthesia on maternal and fetal oxygenation and lipid peroxidation. Br J Anaesth. 2002 Jan;88(1):18-23. doi: 10.1093/bja/88.1.18.

Reference Type RESULT
PMID: 11883375 (View on PubMed)

Khaw KS, Ngan Kee WD, Chu CY, Ng FF, Tam WH, Critchley LA, Rogers MS, Wang CC. Effects of different inspired oxygen fractions on lipid peroxidation during general anaesthesia for elective Caesarean section. Br J Anaesth. 2010 Sep;105(3):355-60. doi: 10.1093/bja/aeq154. Epub 2010 Jun 24.

Reference Type RESULT
PMID: 20576633 (View on PubMed)

Allaouchiche B, Debon R, Goudable J, Chassard D, Duflo F. Oxidative stress status during exposure to propofol, sevoflurane and desflurane. Anesth Analg. 2001 Oct;93(4):981-5. doi: 10.1097/00000539-200110000-00036.

Reference Type RESULT
PMID: 11574369 (View on PubMed)

Yagi K. Lipid peroxides and human diseases. Chem Phys Lipids. 1987 Nov-Dec;45(2-4):337-51. doi: 10.1016/0009-3084(87)90071-5.

Reference Type RESULT
PMID: 3319232 (View on PubMed)

Witko-Sarsat V, Friedlander M, Capeillere-Blandin C, Nguyen-Khoa T, Nguyen AT, Zingraff J, Jungers P, Descamps-Latscha B. Advanced oxidation protein products as a novel marker of oxidative stress in uremia. Kidney Int. 1996 May;49(5):1304-13. doi: 10.1038/ki.1996.186.

Reference Type RESULT
PMID: 8731095 (View on PubMed)

Other Identifiers

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IIBSP-OXI-2013-62

Identifier Type: -

Identifier Source: org_study_id