| CTRI Number |
CTRI/2024/03/064248 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of blood flow changes in brain with different anaesthetic drugs in patients with Moya Moya disease and undergoing bypass surery. |
|
Scientific Title of Study
|
Intraoperative distal MCA flow velocity patterns during bypass procedures in Moya Moya disease patients- A prospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ivy George |
| Designation |
Senior resident |
| Affiliation |
NIMHANS |
| Address |
Senior resident
Department of Neuro Anaesthesia and Neuro Criticalcare
NIMHANS
Bengaluru
Mathalikunnel House
Mudavoor P.O.
Muvattupuzha
Ernakulam
Kerala, 686669
Bangalore
KARNATAKA
560011
India |
| Phone |
9825552673 |
| Fax |
|
| Email |
ivyakku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Radhakrishnan |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuro Anaesthesia and Neuro Criticalcare
NIMHANS
Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9480829719 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Radhakrishnan |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuro Anaesthesia and Neuro Criticalcare
NIMHANS
Bengaluru
Bangalore
KARNATAKA
560011
India |
| Phone |
9480829719 |
| Fax |
|
| Email |
mrks1974@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
Department of Neuro Anaesthesia and Neuro Criticalcare |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ivy George |
NIMHANS |
Faculty building, 3rd floor, Department of Neuro Anaesthesia and Neuro Critical care
Bangalore
KARNATAKA |
9825552673
ivyakku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypercarbia, hypocarbia, hypertension.(within the physiological limits and range) |
Hypercarbia-To increase end tidal carbon dioxide values, ventilatory settings are adjusted by reducing the respiratory frequency inititally followed by changes in the set tidal volume/Insp pressures.
Hypocarbia-To decrease end tidal carbon dioxide values, ventilatory settings are adjusted by increasing the respiratory frequency inititally followed by changes in the set tidal volume/Insp pressures.
Hypertension-For blood pressure augmentation, infusions of intravenous phenylephrine will be used.
|
| Comparator Agent |
Sevoflurane, Isoflurane, Desflurane and Propofol |
Comparing blood flow velocities with different inhalational and intravenous agents pre and post anastomosis. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
Proposed surgical procedure is modified (direct to indirect)
Pregnant women.
Those patients who refuse to give consent
Patients with Ischaemic Heart Disease (IHD)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Preanastomosis and post anastomosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
To compare the changes in mean distal MCA CBFV following blood pressure augmentation after anastomosis & correlation with post-operative hyperaemic complications.
To observe the changes in regional cerebral oxygenation (rSO2) before & after anastomosis & correlation with post-operative ischemic & hyperaemic complications.
|
Hypercapnea-Before hypercapnia & at 5 min after achieving hypercapnia
Hypocapnia-Before hypocapnia & at 5 min after achieving hypocapnia
BP augmentation-Before BP augmentation and
at 5 min after desired increase in MAP being achieved
Cerebral oximetery-Before & after anastomosis
Baseline, Post intubation, post hypercapnic challenge, post hypocapnic challenge, post hypertensive challenge, Post clamping, Post Anastomosis , Surgery end & Before reversal
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |