Centre For Clinical Research And Biostatistics (CCRB)

Back History

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

Not Applicable

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

Hong Kong

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

Hong Kong

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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.706-T

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

iv Dosage of the intervention

0-6 mcg

v Duration of the intervention

Approximately 60 min

vi Frequency of the intervention

continuous

16 Comparative Treatments

i Description/ name of comparative treatments

Phenylephrine, norepinephrine

ii Dosage form of the comparative treatments

iv

iii Dosage of the comparative treatments

0-100 mcg

iv Duration of the comparative treatments

Approximately 60 min

v Frequency of the comparative treatments

continuous

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients scheduled for elective or non-elective caesarean delivery under spinal anaesthesia during normal working hours at Prince of Wales Hospital, Shatin, Hong Kong. In keeping with the pragmatic study design, inclusion criteria will be broad and all patients having caesarean delivery will be assessed for suitability except for those matching the specific exclusion criteria.

ii Exclusion Criteria

Known fetal abnormality, 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, known allergy to phenylephrine or norepinephrine.

iii Age Minimum

18

iv Age Maximum

99

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

parallel group

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

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-06-01

21 Target Sample Size

668

22 Recruitment Status

Complete

23 Primary Outcome

Umbilical arterial blood pH

24 Secondary Outcome

Incidence of maternal hypotension.
Incidence of maternal bradycardia.
Incidence of maternal nausea or vomiting.
Other umbilical arterial and venous blood gas parameters.

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

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Trial Detail