UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051384 |
|---|---|
| Receipt number | R000058620 |
| Scientific Title | Middle Cerebral artery flow velocity changes during pneumoperitoneum for laproscopic surgeries- The feasibility of Transcranial colour coded duplex ultrasonography |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2024/06/19 15:35:50 |
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Basic information
Public title
Middle Cerebral artery flow velocity changes during pneumoperitoneum for laproscopic surgeries- The feasibility of Transcranial colour coded duplex ultrasonography
Acronym
MCA-LAPRO
Scientific Title
Middle Cerebral artery flow velocity changes during pneumoperitoneum for laproscopic surgeries- The feasibility of Transcranial colour coded duplex ultrasonography
Scientific Title:Acronym
MCA-LAPRO
Region
| Asia(except Japan) |
Condition
Condition
PROSPECTIVE OBSERVATIONAL TRIAL.
NOT YET RECRUITING
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Urology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in Middle cerebral artery (MCA) flow velocity during pneumoperitoneum for laparoscopic surgeries.
Basic objectives2
Others
Basic objectives -Others
OTHER
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IMPACT OF PNEUMOPERITONEUM ON MIDDLE CEREBRAL ARTERY FLOW VELOCITY
Key secondary outcomes
DURATION OF EMERGENCE FROM ANESTHESIA
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient of either gender aged 18 years and above undergoing laproscopic surgeries.
Key exclusion criteria
(i) No consent
(ii) Pregnant patients
(iii) Contraindication to study drugs
(iv) Patients with maxillofacial injuries
(v) Patients with intracranial vascular pathology
(vi) Airway contamination or likelihood of pulmonary aspiration
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | KUNAL |
| Middle name | |
| Last name | KUMAR |
Organization
INDIRA GANDHI MEDICAL COLLEGE SHIMLA
Division name
NEUROANESTHESIA SUPER-SPECIALITY CELL, under department of Anaesthesiolgy,
Zip code
171001
Address
Assistant Professor, NEUROANESTHESIA SUPER-SPECIALITY CELL, under department of Anaesthesiolgy, IGMC Shimla
TEL
7018388348
kunaal_kumar@yahoo.com
Public contact
Name of contact person
| 1st name | KUNAL |
| Middle name | |
| Last name | KUMAR |
Organization
INDIRA GANDHI MEDICAL COLLEGE SHIMLA
Division name
NEUROANESTHESIA SUPER-SPECIALITY CELL, under department of Anaesthesiolgy,
Zip code
171001
Address
Assistant Professor, NEUROANESTHESIA SUPER-SPECIALITY CELL, under department of Anaesthesiolgy, IGMC
TEL
7018388348
Homepage URL
kunaal_kumar@yahoo.com
Sponsor or person
Institute
INDIRA GANDHI MEDICAL COLLEGE, SHIMLA
Institute
Department
Personal name
Funding Source
Organization
INDIRA GANDHI MEDICAL COLLEGE, SHIMLA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
INSTITUTIONAL ETHICS COMMITTEE, IGMC SHIMLA
Address
INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI MEDICAL COLLEGE & HOSPITAL, SHIMLA- 171001
Tel
7042866015
iec.igmc.sml@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 26 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
After visualization of circle of Willis by transcranial color coded duplex (TCCD) ultrasonography in B-mode, the insonation of one of the MCA will be done via transtemporal window, using a phased array transducer of SonositeTM ultrasound machine on ultrasonography, the insonation of MCA will be done using a phased array transducer of SonositeTM ultrasound machine. The flow velocities will be recorded at three time points
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058620
