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Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04216823
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
aijun xu, Tongji Hospital

Brief Summary:
The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.

Condition or disease Intervention/treatment
Supraclavicular Brachial Plexus Block Device: perfusion index

Detailed Description:
The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
Estimated Study Start Date : April 2, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Group/Cohort Intervention/treatment
Sevoflurane Group
sevoflurane is used for anesthetic induction
Device: perfusion index
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients

Propofol Group
intravenous anesthetic propofol is used for anesthetic induction
Device: perfusion index
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients




Primary Outcome Measures :
  1. perfusion index [ Time Frame: the time span between 1 day preoperative and 24 hours after surgery ]
    Correlation between success of supraclavicular brachial plexus block and perfusion index


Secondary Outcome Measures :
  1. mean arterial blood pressure [ Time Frame: the time span between 1 day preoperative and 24 hours after surgery ]
    perioperative mean arterial blood pressure in mmHg

  2. heart rate [ Time Frame: the time span between 1 day preoperative and 24 hours after surgery ]
    perioperative heart rate as beat/min

  3. PI ratio [ Time Frame: up to 10 minutes ]
    Correlate between baseline PI and 10min after supraclavicular brachial plexus block



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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.
Criteria

Inclusion Criteria:

  • ASA physical status I-II
  • Children undergoing Upper limb surgery.
  • Parents' agreement.

Exclusion Criteria:

  • Parents' refusal.
  • Children with behavioral changes
  • Children with physical developmental delay
  • Children on treatment with sedative or anticonvulsant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216823


Contacts
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Contact: Aijun Xu, Dr. 86-27-83663173 ajxu@tjh.tjmu.edu.cn

Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Hong Liu, Dr. Huazhong university, Tongji medical college
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Responsible Party: aijun xu, associate professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04216823    
Other Study ID Numbers: PISP
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by aijun xu, Tongji Hospital:
perfusion index
supraclavicular brachial plexus block
children