Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00330

2 Trial Registration Date

2012-07-25

i Registration Status

Prospective

3 Secondary IDs

N/A

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

Prof Warwick D. Ngan Kee

ii Address

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

iii Phone

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 Warwick D. Ngan Kee

ii Address

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

iii Phone

26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Closed-loop feedback computer-controlled phenylephrine for maintenance of blood pressure during spinal anaesthesia for caesarean section: randomized comparison of automated bolus versus infusion

10 Public Title

Closed-loop feedback computer-controlled phenylephrine for maintenance of blood pressure during spinal anaesthesia for caesarean section: randomized comparison of automated bolus versus infusion

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

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?

2012-07-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pregnancy

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Computer-controlled delivery system

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 min approximately

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Computer-controlled administration of phenylephrine by automated bolus or 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

American Society of Anesthesiologists Physical Status 1 or 2 normotensive non-labouring parturients with term singleton pregnancies who are scheduled for elective Caesarean section and who have been judged suitable and have agreed to have for spinal anaesthesia according to usual clinical criteria.

ii Exclusion Criteria

Known fetal abnormality, preexisting or pregnancy-induced hypertension, known cardiovascular or cerebrovascular disease, thrombocytopaenia, coagulopathy, or any medical contraindication to spinal anaesthesia, age < 18 years, weight <50 kg or >100 kg, height <140 cm or >180 cm, inability or refusal to give informed consent.

iii Age Minimum

18

iv Age Maximum

nil

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-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

2012-08-01

21 Target Sample Size

214

22 Recruitment Status

Recruiting

23 Primary Outcome

Median absolute performance error for systolic blood pressure in the first 10 min after spinal injection

24 Secondary Outcome

Maternal heart rate and cardiac output - from spinal injection until delivery.
Umbilical cord blood gases and neonatal Apgar scores – after delivery.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002418

28 Date of Registration in Primary Registry

2012-08-13

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

http://www.cuhk.edu.hk/med/ans

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Trial History Detail on 2012-12-07