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Trial History Detail on 2016-09-02

CUHK_CCRB00514

2016-06-03

Prospective

2016.082-T

The Chinese University of Hong Kong

The Chinese University of Hong Kong

N/A

Not Applicable

Professor Warwick Ngan Kee

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

+852 26322735

warwick@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong, China

NGAN KEE Warwick Dean

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

26322735

warwick@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong, China

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

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

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

Hong Kong, China

Yes

2016-05-03

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.082-T

Hypotension

Drug

Norepinephrine versus phenylephrine

Intravenous infusion

7.5 mcg/ml

Approx 30 min

continuous infusion

Phenylephrine

Intravenous infusion

100 mcg/ml

Approx 30 min

continuous infusion

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.

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.

18

no maximum

Female

Interventional

Randomized

computer-generated randomization code

Active

Double-blind

Parallel

4

2016-07-01

274

Not Yet Recruiting

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

Electocardiography and pulse oximetry

interval from induction of anaesthesia to fetal delivery

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

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

interval from induction of anaesthesia to fetal delivery

No

2018-01-03

ChiCTR-IIR-16008596

2016-06-03

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