Does Sevoflurane Cause Genomic Damage

January 11, 2019 updated by: Jubilee Mission Medical College and Research Institute

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Thrissur, Kerala, India, 680005
        • Recruiting
        • Jubilee Mission Medical College and Research Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group S
These patients will be induced and maintained with sevoflurane during anaesthesia.
Drug: Sevoflurane
The patients in the group S will be exposed to routine concentrations of sevoflurane during anaesthesia.
Other Names:
  • sevorane
Sham Comparator: Group P
These patients will be induced and maintained with propofol during anaesthesia.
Drug: Propofol
These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.
Other Names:
  • fresofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic instability
Time Frame: It will be assessed at 2 hours after anaesthesia.
Genomic instability will be assessed using comet assay
It will be assessed at 2 hours after anaesthesia.
Genomic instability
Time Frame: It will be assessed 48 hours after anaesthesia.
Genomic instability will be assessed using comet assay.
It will be assessed 48 hours after anaesthesia.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jubilee Mission Medical College and Research Institute

Investigators

  • Principal Investigator: Vigil Peter, MD, Jubilee Mission Medical College and Research Institute, Thrissur, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/16/IEC / JMMC&RI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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