臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 25, 2019
Last modified on	Mar. 24, 2021
Trial ID	jRCTs041190070

Scientific Title	Phenylephrine infusion for prevention of hypotension during spinal anesthesia for elective cesarean section
Public Title	Phenylephrine infusion for prevention of hypotension during spinal anesthesia for elective cesarean section

Completion date	Dec. 14, 2020
Result actual enrolment	46
Baseline Characteristics	46 patients (median age, 33 years) were enrolled.
Participant flow	Between October 11, 2019 and December 14, 2020, 46 patients signed the informed consent form. All 46 participants were enrolled and randomly assigned to a phenylephrine group (23) and conventional group (23). One patient in the phenylephrine group was excluded from the analysis as a protocol deviation, because the uterus was not displaced to the left. In addition, one patient in the conventional treatment group was excluded from the analysis because the effect of spinal anesthesia was insufficient and the anesthesia method was changed.
Adverse events	Adverse events were not observed.
Outcome measures	Primary endpoint: The occurrence of hypotension was significantly lower in the phenylephrine group (2/22 cases in the phenylephrine group and 14/22 cases in the conventional group) (P<0.001) Secondary endpoints: (1)The rate of change in LF/HF in heart rate variability analysis was 2.00 [0.78-2.57] in the phenylephrine group and 1.48 [0.43-2.85] in the conventional group, with no significant difference between the two groups (P=0.751). (2)The dose of phenylephrine administered for treatment for hypotension was 0 [0-0] in the phenylephrine group and 0.1 [0-0.1] in the conventional group, with significantly lower doses in the phenylephrine group (P<0.001). (3)Complications of nausea or vomitting were 4/22 in the phenylephrine group and 19/22 in the conventional group, with no significant difference between the two groups (P=0.099). (4)The incidence of bradycardia was 0/22 in the phenylephrine group and 2/22 in the conventional group, with no significant difference between the two groups (P=0.244). (5)The apgar score (1 min) was 9 [8-9] in the phenylephrine group and 8 [8-9] in the conventional group, with no significant difference between the tow groups (P=0.602). The apgar score (5 min) was 9 [9-10] in the phenylephrine group and 9 [9-9] in the conventional group, with no significant difference between the two groups (P=0.058). (6)The PH of umbilical cord blood gas was 7.28 (0.04) in the phenylephrine group and 7.29 (0.03) in the conventional group, with no significant difference between the two groups (P=0.257). The BE of umbilical cord blood gas was -2.27 (1.55) in the phenylephrine group and -2.38 (1.58) in the conventional group, with no significant difference between the two groups (P=0.822).
Brief summary	46 participants were enrolled into this study. The frequency of hypotension, the primary endpoint, was significantly lower in the phenylephrine group than in the conventional group.
Date of posting of results summaries	Mar. 18, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041190070

Contact for Scientific Queries	Name	Nakashima Daiki
	Affiliation	Gifu University Hospital
	Address	1-1 Yanagido Gifu, Japan
	Telephone	+81-58-230-6404
	E-mail	isi_m2001046@yahoo.co.jp
Contact for Public Queries	Name	Nakashima Daiki
	Affiliation	Gifu University Hospital
	Address	1-1 Yanagido Gifu, Japan
	Telephone	+81-58-230-6404
	E-mail	isi_m2001046@yahoo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 25, 2019
Actual date of first enrollment		Oct. 11, 2019
Target sample size		46
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.elective caesarean section under spinal anesthesia 2.age over 20 years old 3.written informed consent
	Exclusion Criteria	1.cannot communicate 2.patients complicated with hypertension, heart and vessel disease, diabetes 3.multiple pregnancy, excessive amniotic fluid, fetal stunt 4.patients whose BMI >35 5.patients who are considered to be inappropriate
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		elective caesarean section
Intervention(s)		All participants are divided into two groups, phenylephrine group and conventional group. In phenylephrine group, at the same time of spinal anesthesia, starting preventive infusion of phenylephrine 0.5 microgram/kg/min and gradually discontinuing based on the protocol. Treat hypotension in a same way for both groups.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Occurrence of hypotension
Secondary Outcome(s)		Heart rate variability, total dose of phenylephrine, occurrence of nausea or/and vomiting, occurrence of bradycardia, apgar score, PH BE of umbilical cord blood gas

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	Kawasumi 1, Mizuho cho, Mizuho ku, Nagoya, Aichi
Telephone	+81-52-858-7215
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	July. 02, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 24, 2021	(this page)	Changes
3	Jan. 29, 2021	Detail	Changes
2	May. 15, 2020	Detail	Changes
1	Sept. 25, 2019	Detail

List of change history