Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00315

2 Trial Registration Date

2012-03-16

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

RGC GRF Grant application submitted

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

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, 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

Professor Warwick D. Ngan Kee

ii Address

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, 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

Randomized Evaluative Study of Phenylephrine Or Norepinephrine for maintenance of blood pressure during spinal anaesthesia for caesarean Delivery: The RESPOND study

10 Public Title

Randomized Evaluative Study of Phenylephrine Or Norepinephrine for maintenance of blood pressure during spinal anaesthesia for caesarean Delivery: The RESPOND study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

The RESPOND study

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?

2012-02-07

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

Drug

Please specify

ii Description/ name of Intervention/article

Norepinephrine

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

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

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, weight <50 kg or >100 kg, height <140 cm or >180 cm, inability or refusal to give informed consent, age < 18 years, patients taking monoamine oxidase inhibitors or tricyclic antidepressants, patients with mesenteric or peripheral vascular thrombosis, patients with renal impairment.

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

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

2012-07-01

21 Target Sample Size

104

22 Recruitment Status

Complete

23 Primary Outcome

Cardiac output 5 min after spinal injection

24 Secondary Outcome

Haemodynamic control - intraoperatively
Umbilical cord blood gases – after delivery
Umbilical cord blood catecholamine concentrations – 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-12002135

28 Date of Registration in Primary Registry

2012-04-29

* 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 2014-03-18