Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00432

2 Trial Registration Date

2014-09-08

iRegistration Status

Prospective

3 Secondary IDs

2014.282-T

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

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Professor W. Ngan Kee

ii Address

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

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

i Name

Prof W. Ngan Kee

ii Address

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

Dose-Response Study of Phenylephrine and Norepinephrine for the Treatment of Hypotension during Spinal Anaesthesia for Caesarean Section

10 Public Title

Dose-Response Study of Phenylephrine and Norepinephrine for the Treatment of Hypotension during Spinal Anaesthesia for Caesarean Section

i Public Title in Chinese 研究名稱

於脊髓麻醉剖腹生產期間使用去氧腎上腺素“Phenylephrine”和去甲腎上腺素“Norepinephrine”管理產婦血壓的劑量反應研究

11 Short Title (Optional)

Phenylephrine norepinephrine dose-response

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-05-21

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.282-T

14 Medical Condition Being Studied

Hypotension

15Intervention

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

Phenylephrine 60-200mcg

v Duration of the intervention

2 minutes

vi Frequency of the intervention

once

16Comparative Treatments

i Description/ name of comparative treatments

Phenylephrine, norepinephrine

ii Dosage form of the comparative treatments

IV

iii Dosage of the comparative treatments

Norepinephrine 4-12mcg

iv Duration of the comparative treatments

2 min

v Frequency of the comparative treatments

once

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

American Society of Anesthesiologists Physical Status 1 or 2 non-labouring normotensive parturients with term singleton pregnancies who are scheduled for elective or semi-elective Caesarean section and who have been judged suitable and have agreed to have spinal anaesthesia according to usual clinical criteria, baseline systolic blood pressure 90–140 mmHg

ii Exclusion Criteria

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

iii Age Minimum

18

iv Age Maximum

999

v Gender

Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Randomized

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

2014-10-01

21 Target Sample Size

180

22 Recruitment Status

Complete

23 Primary Outcome

Systolic blood pressure 1 minute after drug administration

24 Secondary Outcome

N/A

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14005206

28 Date of Registration in Primary Registry

2014-09-10

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Trial Detail