Study Results
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Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2018-09-01
2019-12-31
Brief Summary
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Detailed Description
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1. To find out if sevoflurane induces genomic instability in children undergoing cleft lip and palate repair.
2. To assess the magnitude of genomic damage caused by the sevoflurane anaesthesia.
3. To evaluate the reversibility of the induced genomic instability when exposure is discontinued.
STUDY DESIGN Type of study : Prospective Comparative Study Research population : All children scheduled for surgical repair of cleft lip or palate admitted in the Department of Plastic Surgery of our hospital, who satisfy the inclusion and exclusion criteria.
Sample Size : A total of 30 children will be enrolled for the study. METHODOLOGY Children scheduled to undergo surgical repair of cleft lip or palate were enrolled for the study, after addressing the inclusion and exclusion criteria.
A peripheral blood sample of 1.5 ml (S-1) will be taken before the induction of anaesthesia .All children will be randomly allocated into two groups - group S and P.All children will be premedicated with Inj.Glycopyrolate 0.01 mg/kg . Children in group S will be induced with sevoflurane, whereas children in group P will be induced with propofol.All children will be intubated using I / V Vecuronium 0.1 mg / kg .Analgesia will be provided using I / V Fentanyl 1.5 mcg / kg. Depth of anaesthesia will be maintained with sevoflurane in group S and with propofol infusion in group P. The vitals will be monitored as usual intraop and the children will be extubated at the end of the surgery.
Peripheral blood samples of 1.5 ml each will be taken immediately after extubation (S-2) , after 48 hours (S-3)and after 120 hours (S-4).A fifth blood sample (S-5) will be taken on the 14th postoperative day All the blood samples will be evaluated for genomic instability using Alkaline Comet Assay by the Genetics Lab of our hospital.
STATISTICAL ANALYSIS
The findings of this study will be analysed using Chi-square test, Student's t-test, Mann-Whitney U test, mean and standard deviation to yield the final results. The study will be considered statistically significant with a p value of less than 0.05
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Peripheral blood samples of 1.5 ml each will be taken immediately after extubation (S-2) , after 48 hours (S-3)and after 120 hours (S-4).A fifth blood sample (S-5) will be taken on the 14th postoperative day.
These blood samples will be evaluated for genomic instability using Alkaline Comet Assay and micronucleus test by the Genetics Lab of our hospital.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group S
These patients will be induced and maintained with sevoflurane during anaesthesia.
Sevoflurane
The patients in the group S will be exposed to routine concentrations of sevoflurane during anaesthesia.
Group P
These patients will be induced and maintained with propofol during anaesthesia.
Propofol
These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.
Interventions
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Sevoflurane
The patients in the group S will be exposed to routine concentrations of sevoflurane during anaesthesia.
Propofol
These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 syndromic cleft lip or palate.
* Children with bleeding disorders.
* Children with known allergy to any of the concerned drugs.
6 Months
12 Months
ALL
No
Sponsors
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Jubilee Mission Medical College and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Vigil Peter, MD
Role: PRINCIPAL_INVESTIGATOR
Jubilee Mission Medical College and Research Institute, Thrissur, India
Locations
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Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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 Work Environ Health. 2013 Nov;39(6):618-30. doi: 10.5271/sjweh.3358. Epub 2013 Mar 22.
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. doi: 10.1016/s1383-5742(99)00053-8.
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.x. Epub 2008 Jun 6.
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 2049-9752,10.7243/2049-9752-2-26,2013
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. doi: 10.1016/j.ijheh.2007.09.001. Epub 2007 Nov 26.
Alcaraz M, Quesada S, Armero D, Martin-Gil 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.
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.2011.09.007. Epub 2011 Sep 16.
Other Identifiers
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08/16/IEC / JMMC&RI
Identifier Type: -
Identifier Source: org_study_id
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