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Preload or coload for prevention of hypotension after spinal anesthesia for cesarean delivery

Status Approved

First Submitted Date

2012/01/11
Registered Date

2012/01/18
Last Updated Date

2014/03/14

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0000324
Unique Protocol ID	B-0192-090-011
Public/Brief Title	Preload or coload for prevention of hypotension after spinal anesthesia for cesarean delivery
Scientific Title	Preload or coload for prevention of hypotension after spinal anesthesia for cesarean delivery
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-0192-090-011
Approval Date	2012-01-12
Institutional Review Board Name	Institutional Review Board of Seoul National University Bundang Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jung-Won Hwang
Title	Vice professor
Telephone	+82-31-787-7499
Affiliation	Seoul National University Bundang Hospital
Address
Contact Person for Public Queries
Name	Jung-Won Hwang
Title	Vice professor
Telephone	+82-31-787-7499
Affiliation	Seoul National University Bundang Hospital
Address
Contact Person for Updating Information
Name	Ah-Young Oh
Title	Assistant Professor
Telephone	+82-31-787-7499
Affiliation	Seoul National University Bundang Hospital
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2012-01-12 Actual
Target Number of Participant	80
Primary Completion Date	2012-08-20
Study Completion Date	2013-02-19
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Completed
Date of First Enrollment	2012-01-12 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute
Project ID	B-0192-090-011

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Spinal anesthesia for C/S frequently results in hypotension due to sympathetic block and vasodilation.Volume loading is necessary for the prevention of hypotension and crystalloid is used frequently because it is less expansive and induces less anaphylaxis. However, the duration of crystalloids remaining in vessel is short and the question remains if it could prevent hypotension after spinal anesthesia. In this study, we evaluated and compared the effect of preload and coload of crystalloid solution during spinal anesthesia for Cesarean section

Study Summary Information

Lay Summary

Spinal anesthesia for C/S frequently results in hypotension due to sympathetic block and vasodilation.Volume loading is necessary for the prevention of hypotension and crystalloid is used frequently because it is less expansive and induces less anaphylaxis. However, the duration of crystalloids remaining in vessel is short and the question remains if it could prevent hypotension after spinal anesthesia. In this study, we evaluated and compared the effect of preload and coload of crystalloid solution during spinal anesthesia for Cesarean section

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	groupA: rapid infusion of 15 cc/kg Hartmann's solution after intrathecal injection of local anesthetic groupB: infusion of 15cc/kc Hartmann's solution after arrival in the delivery room before intrathecal injection of local anesthetic
Number of Arms	2
Arm 1	Arm Label groupA
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description groupA: rapid infusion of 15 cc/kg Hartmann's solution after intrathecal injection of local anesthetic
Arm 2	Arm Label groupB
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description groupB: infusion of 15cc/kc Hartmann's solution after arrival in the delivery room before intrathecal injection of local anesthetic

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (O00-O99)Pregnancy, childbirth and the puerperium (O82.9)Delivery by caesarean section, unspecified
Rare Disease	No
Inclusion Criteria	Gender Female
	Age No Limit~No Limit
	Description parturient undergoing cesarean section under spinal anesthesia
Exclusion Criteria	preeclampsia, cardiac disease, preterm delivery(<37 wks), multiple pregnancy, fetal distress
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	systolic blood pressure
Timepoint	every 1 min until 15 min after the spinal injection of local anesthetic
Primary Outcome(s) 2
Outcome	heart rate
Timepoint	every 1 min until 15 min after the spinal injection of local anesthetic
Secondary Outcome(s) 1
Outcome	the dose of ephedrine administered
Timepoint	until 15 min after the spinal injection of local anesthetic
Secondary Outcome(s) 2
Outcome	nausea
Timepoint	until 15 min after the spinal injection of local anesthetic
Secondary Outcome(s) 3
Outcome	Apgar score of the neonate
Timepoint	1 min, 5 min after delivery
Secondary Outcome(s) 4
Outcome	cord blood gas analysis (arterial and venous)
Timepoint	immediately after delivery
Secondary Outcome(s) 5
Outcome	the level of anesthesia
Timepoint	every 1 min from 3 min after intrathecal injection, until 15 min
Secondary Outcome(s) 6
Outcome	vomiting
Timepoint	until 15 min after the spinal injection of local anesthetic

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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