Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00452

2 Trial Registration Date

2015-04-09

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

Professor Warwick Dean Ngan Kee

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Ngan Shing Street, 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

Professor Warwick Dean Ngan Kee

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Ngan Shing Street, Shatin, Hong Kong

iii Phone

+852 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 RESPOND2 study

10 Public Title

Randomized Evaluative Study of Phenylephrine Or Norepinephrine for maintenance of blood pressure during spinal anaesthesia for caesarean Delivery: The RESPOND2 study

i Public Title in Chinese 研究名稱

評估於脊髓麻醉剖腹生產期間隨機使用去氧腎上腺素“Phenylephrine”或去甲腎上腺素“Norepinephrine”維持產婦血壓 : 反應研究2

11 Short Title (Optional)

The RESPOND2 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?

2015-02-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Hypotension

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Phenylephrine, norepinephrine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Approximately 30 min

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Phenylephrine, norepinephrine

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 or semi-elective caesarean delivery 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

99

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

2015-06-01

21 Target Sample Size

192

22 Recruitment Status

Suspended

23 Primary Outcome

Umbilical cord blood oxygenation

24 Secondary Outcome

Serial changes in blood pressure, heart rate and cardiac output during the period from induction to fetal delivery.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-11-21

27 Primary Registry and Trial Identifying Number

ChiCTR-IPR-15006235

28 Date of Registration in Primary Registry

2015-04-13

* 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 2015-08-04