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

Oxidative Stress Clinical Trial

— OSGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619214
• Other study ID #: IIBSP-OXI-2013-62
• Status: Recruiting
• Phase: Phase 4
• First received: November 25, 2015
• Last updated: November 30, 2015
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Sebastian Castrillon, M.D
• Phone: 00 34 935537541
• Email: scastrillon[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Drug:
• 30% of oxygen concentration.
30% oxygen concentration during one hour of general anesthesia.
• 60% of oxygen concentration.
60% oxygen concentration during one hour of general anesthesia.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View Citation

Alonso de Vega JM, Díaz 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. — View Citation

Alonso de Vega JM, Díaz J, Serrano E, Carbonell LF. Plasma redox status relates to severity in critically ill patients. Crit Care Med. 2000 Jun;28(6):1812-4. — View Citation

Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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: 10.10 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Eur Respir J. 2003 May;21(5):911. — View Citation

Winter PM, Smith G. The toxicity of oxygen. Anesthesiology. 1972 Aug;37(2):210-41. Review. — View Citation

Witko-Sarsat V, Friedlander M, Capeillère-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. — View Citation

Yagi K. Lipid peroxides and human diseases. Chem Phys Lipids. 1987 Nov-Dec;45(2-4):337-51. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Malondialdehyde level	A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.	Baseline and after one hour of general anesthesia	Yes
Secondary	Change in proteic oxidation level	A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.	Baseline and after one hour of general anesthesia.	Yes
Secondary	Change in glutathion level	A blood sample is obtained before general anesthesia and a second sample is obtained one hour after the oxygen concentration has been fixed in the anesthesia machine.	Baseline and after one hour of general anesthesia.	Yes