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.
STUDY GOALS AND OBJECTIVES
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
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