Does Sevoflurane Cause Genomic Damage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03109119|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia; Adverse Effect||Drug: Sevoflurane Drug: Propofol||Phase 4|
STUDY GOALS AND OBJECTIVES
- To find out if sevoflurane induces genomic instability in children undergoing cleft lip and palate repair.
- To assess the magnitude of genomic damage caused by the sevoflurane anaesthesia.
- 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.
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
Active Comparator: Group S
These patients will be induced and maintained with sevoflurane during anaesthesia.
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.
These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.
Other Name: fresofol
- 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.
- 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.
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
|Contact: Vigil Peter, MDemail@example.com|
|Contact: Alex George, PhDfirstname.lastname@example.org|
|Principal Investigator:||Vigil Peter, MD||Jubilee Mission Medical College and Research Institute, Thrissur, India|