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Does Sevoflurane Cause Genomic Damage

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ClinicalTrials.gov Identifier: NCT03109119
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jubilee Mission Medical College and Research Institute

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.

Condition or disease Intervention/treatment Phase
Anesthesia; Adverse Effect Drug: Sevoflurane Drug: Propofol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

All children will be randomly allocated into two groups - group S and P. Children in group S will be anaesthetised with sevoflurane, whereas children in group P will be anaesthetised with propofol.

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a double blinded study, where the participants are randomly selected using a computer - generated number and allocated to any one of the two groups. Both the patient and the outcome assessor will be blinded.
Primary Purpose: Supportive Care
Official Title: Does Sevoflurane Induce Genomic Instability in Patients Undergoing General Anaesthesia?
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: fresofol




Primary Outcome Measures :
  1. Genomic instability [ Time Frame: It will be assessed at 2 hours after anaesthesia. ]
    Genomic instability will be assessed using comet assay

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


Secondary Outcome Measures :
  1. Reversibility of the genomic instability [ Time Frame: It will be assessed on fifth day after anaesthesia. ]
    Assessed using comet assay

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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109119


Contacts
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Contact: Vigil Peter, MD 918593821000 drpeteralapatt@gmail.com
Contact: Alex George, PhD 914872432200 alexgeorge@jmmc.ac.in

Locations
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India
Jubilee Mission Medical College and Research Institute Recruiting
Thrissur, Kerala, India, 680005
Contact: Vigil Peter, MD    918593821000    drpeteralapatt@gmail.com   
Contact: Alex George, PhD    914872432200    alexgeorge@jmmc.ac.in   
Sponsors and Collaborators
Jubilee Mission Medical College and Research Institute
Investigators
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Principal Investigator: Vigil Peter, MD Jubilee Mission Medical College and Research Institute, Thrissur, India
Publications of Results:
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

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Responsible Party: Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT03109119    
Other Study ID Numbers: 08/16/IEC / JMMC&RI
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jubilee Mission Medical College and Research Institute:
genomic instability
Sevoflurane
General anaesthesia
Additional relevant MeSH terms:
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Genomic Instability
Pathologic Processes
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation