NCT02619214

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.6 years

First QC Date

November 25, 2015

Last Update Submit

November 30, 2015

Conditions

Oxidative Stress

Keywords

Oxidative StressOxygenGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in proteic oxidation level

    Baseline and after one hour of general anesthesia.

  • Change in glutathion level

    Baseline and after one hour of general anesthesia.

Study Arms (2)

Oxygen 30%

EXPERIMENTAL

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

Drug: 30% of oxygen concentration.

Oxygen 60%

EXPERIMENTAL

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

Drug: 60% of oxygen concentration.

Interventions

30% of oxygen concentration.DRUG

30% oxygen concentration during one hour of general anesthesia.

Oxygen 30%
60% of oxygen concentration.DRUG

60% oxygen concentration during one hour of general anesthesia.

Oxygen 60%

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoking Habit
  • Pregnancy
  • No compensated disease.
  • ASA 3 or Higher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Related Publications (14)

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

    PMID: 11089981RESULT

  • 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.

    PMID: 12570108RESULT

  • 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.

    PMID: 11325214RESULT

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

    PMID: 4559456RESULT

  • 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.

    PMID: 3717636RESULT

  • 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.

    PMID: 14568884RESULT

  • 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.

    PMID: 21596843RESULT

  • 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.

    PMID: 10890625RESULT

  • 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.

    PMID: 12163793RESULT

  • 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.

    PMID: 11883375RESULT

  • 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.

    PMID: 20576633RESULT

  • 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.

    PMID: 11574369RESULT

  • 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.

    PMID: 3319232RESULT

  • 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.

    PMID: 8731095RESULT

Study Officials

  • Sebastian Castrillon, M.D.

    Anesthesiologist.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Castrillon, M.D

CONTACT

00 34 935537541scastrillon@santpau.cat

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 2, 2015

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

ES(1)