Clinical Trial: Does Sevoflurane Cause Genomic Damage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Does Sevoflurane Induce Genomic Instability in Patients Undergoing General Anaesthesia?

Brief Summary: 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.

Detailed Summary:

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 60 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
Sponsor: Jubilee Mission Medical College and Research Institute

Current Primary Outcome:

  • Genomic instability [ Time Frame: It will be assessed at 2 hours after anaesthesia. ]
    Genomic instability will be assessed using comet assay
  • Genomic instability [ Time Frame: It will be assessed 48 hours after anaesthesia. ]
    Genomic instability will be assessed using comet assay.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reversibility of the genomic instability [ Time Frame: It will be assessed on fifth day after anaesthesia. ]
    Assessed using comet assay
  • Reversibility of genomic instability [ Time Frame: It will be assessed on the 14th day after anaesthesia. ]
    It will be assessed using comet assay.


Original Secondary Outcome: Same as current

Information By: Jubilee Mission Medical College and Research Institute

Dates:
Date Received: March 20, 2017
Date Started: May 2017
Date Completion: October 2017
Last Updated: April 5, 2017
Last Verified: April 2017