Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00144

2 Trial Registration Date

2007-09-11

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

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

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

Professor Warwick D. Ngan Kee

ii Address

iii Phone

iv Email

email warwick@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Professor Warwick D. Ngan Kee

ii Address

iii Phone

iv Email

email warwick@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Randomized comparison of computer-controlled versus manual infusion of phenylephrine for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

n/a

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-09-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pregnancy/Caesarean section

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Computer-controlled closed-loop feedback phenylephrine infusion

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

1. Computer-controlled closed-loop feedback phenylephrine infusion 2. Manual-controlled phenylephrine infusion

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 criteria: Healthy, term, singleton parturients having elective Caesarean section under spinal anaesthesia.

ii Exclusion Criteria

Exclusion criteria: Onset of labour, hypertension, cardiac disease, cerebrovascular disease, fetal abnormality

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

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

2007-11-01

21 Target Sample Size

222

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Median absolute performance error of serial systolic blood pressure versus baseline

24 Secondary Outcome

n/a

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2009-11-19