NCT03109119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

March 20, 2017

Last Update Submit

January 11, 2019

Conditions

Anesthesia; Adverse Effect

Keywords

genomic instabilitySevofluraneGeneral anaesthesia

Outcome Measures

Primary Outcomes (2)

  • Genomic instability

    Genomic instability will be assessed using comet assay

    It will be assessed at 2 hours after anaesthesia.

  • Genomic instability

    Genomic instability will be assessed using comet assay.

    It will be assessed 48 hours after anaesthesia.

Secondary Outcomes (2)

  • Reversibility of the genomic instability

    It will be assessed on fifth day after anaesthesia.

  • Reversibility of genomic instability

    It will be assessed on the 14th day after anaesthesia.

Study Arms (2)

Group S

ACTIVE COMPARATOR

These patients will be induced and maintained with sevoflurane during anaesthesia.

Drug: Sevoflurane

Group P

SHAM COMPARATOR

These patients will be induced and maintained with propofol during anaesthesia.

Drug: Propofol

Interventions

SevofluraneDRUG

The patients in the group S will be exposed to routine concentrations of sevoflurane during anaesthesia.

Also known as: sevorane
Group S
PropofolDRUG

These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.

Also known as: fresofol
Group P

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

RECRUITING

Related Publications (8)

  • 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.

    PMID: 15306730RESULT

  • 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.

    PMID: 23525098RESULT

  • 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.

    PMID: 10517999RESULT

  • 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.

    PMID: 18540930RESULT

  • 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

    RESULT

  • 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.

    PMID: 18023252RESULT

  • 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.

    PMID: 25386035RESULT

  • 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.

    PMID: 21944903RESULT

MeSH Terms

Conditions

Genomic Instability

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Vigil Peter, MD

    Jubilee Mission Medical College and Research Institute, Thrissur, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vigil Peter, MD

CONTACT

918593821000drpeteralapatt@gmail.com

Alex George, PhD

CONTACT

914872432200alexgeorge@jmmc.ac.in

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 12, 2017

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)