Anesthesia; Adverse Effect Clinical Trial
Official title:
Does Sevoflurane Induce Genomic Instability in Patients Undergoing General Anaesthesia?
This study aims to find out if sevoflurane causes any cell damage to patients undergoing general anaesthesia. In case of any damage, the reversibility of the damage is also assessed. This is a prospective, comparative study carried out in all children scheduled for surgical repair of cleft lip or palate admitted in the Department of Plastic Surgery under Smile Train organisation ìn our hospital,who satisfy the inclusion and exclusion criteria.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 12 Months |
Eligibility |
Inclusion Criteria - Children must have isolated cleft lip or palate. - The surgery must be a primary repair of cleft lip or palate. - The minimum duration of the surgery must be 90 minutes. Exclusion Criteria - Children who have undergone previous surgery. - Children who have syndromic cleft lip or palate. - Children with bleeding disorders. - Children with known allergy to any of the concerned drugs. |
Country | Name | City | State |
---|---|---|---|
India | Jubilee Mission Medical College and Research Institute | Thrissur | Kerala |
Lead Sponsor | Collaborator |
---|---|
Jubilee Mission Medical College and Research Institute |
India,
Alcaraz M, Quesada S, Armero D, Martin-Gíl R, Olivares A, Achel GD. Genotoxicity and cytotoxicity of sevoflurane in two human cell lines in vitro with ionizing radiation. Colomb Med (Cali). 2014 Sep 30;45(3):104-9. eCollection 2014 Jul-Sep. — View Citation
Braz MG, Braz LG, Barbosa BS, Giacobino J, Orosz JE, Salvadori DM, Braz JR. DNA damage in patients who underwent minimally invasive surgery under inhalation or intravenous anesthesia. Mutat Res. 2011 Dec 24;726(2):251-4. doi: 10.1016/j.mrgentox.2011.09.00 — View Citation
Fenech M, Holland N, Chang WP, Zeiger E, Bonassi S. The HUman MicroNucleus Project--An international collaborative study on the use of the micronucleus technique for measuring DNA damage in humans. Mutat Res. 1999 Jul 16;428(1-2):271-83. Review. — View Citation
Musak L, Smerhovsky Z, Halasova E, Osina O, Letkova L, Vodickova L, Polakova V, Buchancova J, Hemminki K, Vodicka P. Chromosomal damage among medical staff occupationally exposed to volatile anesthetics, antineoplastic drugs, and formaldehyde. Scand J Wor — View Citation
Rozgaj R, Kasuba V, Brozovic G, Jazbec A. Genotoxic effects of anaesthetics in operating theatre personnel evaluated by the comet assay and micronucleus test. Int J Hyg Environ Health. 2009 Jan;212(1):11-7. Epub 2007 Nov 26. — View Citation
Szyfter K, Szulc R, Mikstacki A, Stachecki I, Rydzanicz M, Jaloszynski P. Genotoxicity of inhalation anaesthetics: DNA lesions generated by sevoflurane in vitro and in vivo. J Appl Genet. 2004;45(3):369-74. — View Citation
Tania K.de Araujo, Roseane L, Flora M.B.B, Nilson C.R, Cristina W.P, Ricardo Manoel da Cruz et al-Genotoxic effects of anaesthetics in OT personnel evaluated by micronuclei tests Journal of Anaesthesia and Clinical Science ISSN 2049-9752,10.7243/2049-9752
Wiesner G, Schiewe-Langgartner F, Lindner R, Gruber M. Increased formation of sister chromatid exchanges, but not of micronuclei, in anaesthetists exposed to low levels of sevoflurane. Anaesthesia. 2008 Aug;63(8):861-4. doi: 10.1111/j.1365-2044.2008.05498 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genomic instability | Genomic instability will be assessed using comet assay | It will be assessed at 2 hours after anaesthesia. | |
Primary | Genomic instability | Genomic instability will be assessed using comet assay. | It will be assessed 48 hours after anaesthesia. | |
Secondary | Reversibility of the genomic instability | Assessed using comet assay | It will be assessed on fifth day after anaesthesia. | |
Secondary | Reversibility of genomic instability | It will be assessed using comet assay. | It will be assessed on the 14th day after anaesthesia. |
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