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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20180129002 |
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Date of registration:
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29/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of inhalation anesthesia with hyperventilation and total intravenous anesthesia (TIVA) on ICP control in pediatrics with craniosynostosis surgery: A randomized clinical trial
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Scientific title:
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The effect of inhalation anesthesia with hyperventilation and total intravenous anesthesia (TIVA) on ICP control in pediatrics with craniosynostosis surgery: A randomized clinical trial |
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Date of first enrolment:
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01/05/2016 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20180129002 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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iran
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Contacts
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Name:
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Afsaneh
Sadeghi |
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Address:
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7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
19839-63113
tehran
iran |
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Telephone:
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+9802333452740 |
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Email:
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are20935@yahoo.com |
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Affiliation:
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Anesthesiologist, Anesthesiology Research Center (ARC), Shahid Beheshti University of Medical Scienc |
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Name:
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Afsaneh
Sadeghi |
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Address:
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7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
19839-63113
tehran
iran |
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Telephone:
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+9802333452740 |
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Email:
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are20935@yahoo.com |
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Affiliation:
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Anesthesiologist, Anesthesiology Research Center (ARC), Shahid Beheshti University of Medical Scienc |
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Key inclusion & exclusion criteria
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Inclusion criteria: pediatric patients ASA class І -ІІ, age 6 months-2 years old undergoing multiple sutures cranioplasty. Patients with concurrent cardiac, renal, hematologic or pulmonary disease and BMI> 30 were excluded
Exclusion criteria: N/A
Age minimum:
6 Months
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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In this prospective clinical trial study, 40 pediatric patients ASA І-ІІ, 6months- 2years old were included. All of the patients were scheduled for craniosynostosis repair at Mofid Children Hospi
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Intervention(s)
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inhalation anesthesia with hyperventilation ,total intravenous anesthesia (TIVA)
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Experimental Drug,Experimental Drug
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In hyperventilation group (A) patients received isoflurane for maintenance of anesthesia and hyperventilation (Paco2=25-30 mmHg) established during surgery. ,The total intravenous anesthesia (TIVA) group (B) received propofol infusion for anesthesia maintenance and Paco2 was maintained 35 mmHg.
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Primary Outcome(s)
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Intra cranial pressure . During surgery qualitative scale
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Secondary Outcome(s)
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Hemodynamic (mean arterial pressure and heart rate) changes During surgery standard monitoring (Blood pressure (BP), Pulse rate (PR), Electrocardiography (ECG), end tidal carb
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Source(s) of Monetary Support
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Shahid Beheshti University of Medical Sciences
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Mpajouhesh@sbmu.ac.ir
Shahid Beheshti University of Medical Sciences
+982122439781 Ext.
Mpajouhesh@sbmu.ac.ir
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Results
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Results available:
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Date Posted:
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Date Completed:
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01/01/2017 |
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URL:
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