Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00082

2 Trial Registration Date

2005-09-22

i Registration Status

Retrospective

3 Secondary IDs

NA

4 Source(s) of Funding

Departmental Funding

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

n/a

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Prof W. Ngan Kee

ii Address

Dept of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

+852 26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof W. Ngan Kee

ii Address

Dept of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

+852 26322735

iv Email

email warwick@suhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Evaluation of vasopressor combinations for maintenance of maternal blood pressure during spinal anaesthesia for Caesarean section

10 Public Title

Evaluation of vasopressor combinations for maintenance of maternal blood pressure during spinal anaesthesia for Caesarean section

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Vasopressor combinations

12 Countries of Recruitment

hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-07-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Conditions of the Urinary Tract and Sexual Organs, and Pregnancy

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Combinations in different ratios of ephedrine and phenylephrine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

approx 30 min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

vasopressors ephedrine and phenylephrine

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: elective Caesarean section under spinal anaesthesia.

ii Exclusion Criteria

Exclusion: fetal abnormality, hypertension, preeclampsia

iii Age Minimum

18

iv Age Maximum

50

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-08-01

21 Target Sample Size

125

22 Recruitment Status

Complete

23 Primary Outcome

Umbilical artery pH

24 Secondary Outcome

Maternal hemodynamics

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-10

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000665

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

www.cuhk.edu.hk

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Trial History Detail on 2013-01-10