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临床试验/CTRI/2024/03/064248
CTRI/2024/03/064248尚未招募不适用

Intraoperative distal MCA flow velocity patterns during bypass procedures in Moya Moya disease patients- A prospective study.

NIMHANS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMHANS
入组人数
60
试验地点
1
主要终点
To compare intraoperative distal MCA cerebral blood flow velocities in Moya Moya Disease patients receiving Ioflurane, Sevoflurane, Desflurane, Propofol anaesthesia during direct revascularisation (STA-MCA Bypass) surgery.

研究概览

简要总结

This study aims to investigate the differences in intraoperative distal middle cerebral artery (MCA) blood flow velocities under inhalational (Isoflurane, Sevoflurane, and Desflurane) versus intravenous anesthesia in patients with Moya Moya Disease undergoing direct revascularization procedures.

The primary objective is to compare intraoperative distal MCA cerebral blood flow velocities in patients receiving inhalational versus intravenous anesthesia during STA-MCA bypass surgery. Secondary objectives include observing changes in distal MCA mean blood flow volume before and after micro-anastomosis, comparing intraoperative mean distal MCA blood flow velocity changes during hypercapnia and hypocapnia, evaluating changes in mean distal MCA blood flow velocity following blood pressure augmentation, and assessing changes in regional cerebral oxygenation before and after anastomosis.

The study will be conducted as a prospective observational open-labeled non-randomized interventional comparative study at the National Institute of Mental Health and Neurosciences, Bengaluru, over a period of 2 years. Patients meeting inclusion criteria, aged 2 to 65 years with Moya Moya Disease undergoing STA-MCA bypass surgery, will be included. Exclusion criteria include pregnant women, those with modified surgical procedures, and patients with Ischaemic Heart Disease.

Patients will be divided into four groups based on anesthesia type: Isoflurane, Sevoflurane, Desflurane, and Propofol. Intraoperative monitoring will include transcranial Doppler (TCD) recordings, measurement of regional cerebral oxygenation (rSO2), and interventions to adjust carbon dioxide levels and blood pressure. Data collection will include variables such as blood flow velocities, vessel diameter, FiO2, EtCO2, MAP, and MAC.

Sample size estimation suggests a total of 60 patients (15 in each group) to detect clinically significant changes. Statistical analysis will be performed using IBM SPSS Statistics, with RMANOVA utilized for intergroup comparisons. A significance level of p<0.05 will be applied.

Overall, the study aims to provide insights into the impact of anesthesia type on intraoperative cerebral blood flow dynamics in Moya Moya Disease patients undergoing direct revascularization surgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All patients with Moya Moya disease aged 2yrs to 65 years, undergoing direct revascularization surgery ; Superficial Temporal Artery- Middle Cerebral Artery bypass surgery( STA – MCA bypass surgery) with American Society of Anaesthesiology Physical Status ( ASA PS) I and II will be included in the study.

排除标准

  • Proposed surgical procedure is modified (direct to indirect) Pregnant women.
  • Those patients who refuse to give consent Patients with Ischaemic Heart Disease (IHD).

结局指标

主要结局

To compare intraoperative distal MCA cerebral blood flow velocities in Moya Moya Disease patients receiving Ioflurane, Sevoflurane, Desflurane, Propofol anaesthesia during direct revascularisation (STA-MCA Bypass) surgery.

时间窗: Preanastomosis and post anastomosis

次要结局

  • To observe the changes in the distal MCA mean blood flow volume before & after micro-anastomosis under different anaesthesia.(To compare the intraoperative mean distal MCA CBFV changes during hypercapnia prior to & during hypocapnia after micro anastomosis.)

研究者

发起方
NIMHANS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ivy George

NIMHANS

研究点 (1)

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