Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00409

2 Trial Registration Date

2014-04-25

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.561-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

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, The Chinese University of Hong Kong, 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 D. Ngan Kee

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 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 Double-Blinded Comparison of Intravenous Infusion Versus Intravenous Boluses for Administration of Norepinephrine for Maintenance of Blood Pressure during Spinal Anaesthesia for Caesarean Section

10 Public Title

Randomized Double-Blinded Comparison of Intravenous Infusion Versus Intravenous Boluses for Administration of Norepinephrine for Maintenance of Blood Pressure during Spinal Anaesthesia for Caesarean Section

i Public Title in Chinese 研究名稱

隨機雙盲比較手動推注和連續泵注注射去甲腎上腺素“Norepinephrine” 管理產婦於脊髓麻醉剖腹生產期間的血壓

11 Short Title (Optional)

N/A

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?

2013-12-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2013.561-T

14 Medical Condition Being Studied

Hypotension

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Norepinephrine

iii Dosage form of the intervention

5 mcg/ml

iv Dosage of the intervention

0-5 mcg/min

v Duration of the intervention

Approx 30 min

vi Frequency of the intervention

continuous infusion or Q1min bolus

16 Comparative Treatments

i Description/ name of comparative treatments

Administration by intravenous infusion versus administration by intravenous bolus

ii Dosage form of the comparative treatments

Intravenous bolus vs intravenous infusion

iii Dosage of the comparative treatments

0-5 mcg/min

iv Duration of the comparative treatments

30 min approx

v Frequency of the comparative treatments

continuous infusion or Q1min bolus

17 Key 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. Patients will only be eligible for inclusion if their mean baseline systolic blood pressure (SBP) is within the range 90–140 mmHg.

ii Exclusion Criteria

Patients with known fetal abnormality, pre-existing 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.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Female

18 Study Type

Interventional

19 Study 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

2014-05-10

21 Target Sample Size

110

22 Recruitment Status

Complete

23 Primary Outcome

Median absolute performance error (MDAPE)of systolic blood pressure control

24 Secondary Outcome

Changes in heart rate and cardiac output, incidence of maternal nausea and vomiting

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004572

28 Date of Registration in Primary Registry

2014-04-26

Back History

Trial Detail