Does Sevoflurane Induce Genomic Instability in Patients Undergoing General Anaesthesia?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Genomic instability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Months 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group S
These patients will be induced and maintained with sevoflurane during anaesthesia.
干预措施: Sevoflurane (Drug)
Group P
These patients will be induced and maintained with propofol during anaesthesia.
干预措施: Propofol (Drug)
结局指标
主要结局
Genomic instability
时间窗: It will be assessed 48 hours after anaesthesia.
Genomic instability will be assessed using comet assay.
次要结局
- Reversibility of genomic instability(It will be assessed on the 14th day after anaesthesia.)
- Reversibility of the genomic instability(It will be assessed on fifth day after anaesthesia.)
