Clinical trial NCT01013090: Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia
Official title: Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Epidural anesthesia
Spinal anesthesia
Combined spinal-epidural anesthesia
Fluid therapy
Crystalloid
Colloid
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.


Eligibility criteria: Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects
* With contradictions of neuraxial anesthesia

Primary outcomes:
measure: Rate of hypotension
timeFrame: Anesthesia begin (0 min) to 120 min after anesthesia
Secondary outcomes:
measure: Recurrence of hypotension after ephedrine or phenylephrine
timeFrame: Anesthesia begin (0 min) to 120 min after anesthesia
measure: Consumption of ephedrine and phenylephrine
timeFrame: Anesthesia begin (0 min) to 120 min after anesthesia
measure: Duration of hypotension
timeFrame: Anesthesia begin (0 min) to 120 min after anesthesia
measure: Oxygen saturation during hypotension
timeFrame: Anesthesia begin (0 min) to 120 min after anesthesia
measure: One-min and 5-min Apgar scores
timeFrame: The first and fifth minute after cesarean successful delivery
measure: Low umbilical cord pH (artery < 7.20)
timeFrame: At the time of successful delivery (0 min)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: