Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00514

2 Trial Registration Date

2016-06-03

i Registration Status

Prospective

3 Secondary IDs

2016.082-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

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 Ngan Kee

ii Address

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

iii Phone

+852 26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong, China

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

i Name

NGAN KEE Warwick Dean

ii Address

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

iii Phone

26322735

iv Email

warwick@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong, China

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 RESPOND3 study

10 Public Title

Randomized evaluative study of phenylephrine or norepinephrine for maintenance of blood pressure during spinal anaesthesia for caesarean delivery: The RESPOND3 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3

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-05-03

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.082-T

14 Medical Condition Being Studied

Hypotension

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Norepinephrine versus phenylephrine

iii Dosage form of the intervention

Intravenous infusion

iv Dosage of the intervention

7.5 mcg/ml

v Duration of the intervention

Approx 30 min

vi Frequency of the intervention

continuous infusion

16 Comparative Treatments

i Description/ name of comparative treatments

Phenylephrine

ii Dosage form of the comparative treatments

Intravenous infusion

iii Dosage of the comparative treatments

100 mcg/ml

iv Duration of the comparative treatments

Approx 30 min

v Frequency of the comparative treatments

continuous infusion

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

American Society of Anesthesiologists physical status 1-2 patients scheduled for elective caesarean section at ≥ 36 weeks of gestation under spinal anaesthesia during normal working hours at Prince of Wales Hospital, Shatin, Hong Kong.

ii Exclusion Criteria

Known fetal abnormality, inability or refusal to give informed consent, age < 18 years, inability to speak either Chinese or English, multiple gestation, weight <50 kg or >100 kg, preexisting or pregnancy-induced hypertension, 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

no maximum

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

computer-generated randomization code

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

2016-07-01

21 Target Sample Size

274

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Proportion of HR recordings less than 60 beats/min during the interval from induction of anaesthesia to fetal delivery

ii The metric or method of measurement used

Electocardiography and pulse oximetry

iii The timepoint(s) of primary interest

interval from induction of anaesthesia to fetal delivery

24 Secondary Outcome

i The Name of the outcome

1. Precision of BP control assessing using performance error calcuations.3 2. Neonatal Apgar scores. 3. Umbilical arterial and venous blood gases

ii The metric or method of measurement used

Non-invasive blood pressure measurement, clinical assessment, blood gas analysis

iii The timepoint(s) of primary interest

interval from induction of anaesthesia to fetal delivery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-01-03

27 Primary Registry and Trial Identifying Number

ChiCTR-IIR-16008596

28 Date of Registration in Primary Registry

2016-06-03

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Trial History Detail on 2016-09-02