Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia

NCT01013090 | Completed DMC

• 2 other identifiers: NMU-200911-MZ020NJFY09331M041
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

Epidural anesthesia; Spinal anesthesia; Combined spinal-epidural anesthesia; Fluid therapy; Crystalloid; Colloid

Outcome Measures

Primary Outcomes (1)

• Rate of hypotension

  Anesthesia begin (0 min) to 120 min after anesthesia

Secondary Outcomes (6)

• Recurrence of hypotension after ephedrine or phenylephrine

  Anesthesia begin (0 min) to 120 min after anesthesia

• Consumption of ephedrine and phenylephrine

  Anesthesia begin (0 min) to 120 min after anesthesia

• Duration of hypotension

  Anesthesia begin (0 min) to 120 min after anesthesia

• Oxygen saturation during hypotension

  Anesthesia begin (0 min) to 120 min after anesthesia

• One-min and 5-min Apgar scores

  The first and fifth minute after cesarean successful delivery

Study Arms (6)

Epidural crystalloid

ACTIVE COMPARATOR

Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section

Drug: Ringer's Lactate

Epidural colloid

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section

Drug: Six percent hydroxyethyl starch

Spinal crystalloid

ACTIVE COMPARATOR

Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section

Drug: Ringer's Lactate

Spinal colloid

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section

Drug: Six percent hydroxyethyl starch

CSEA crystalloid

ACTIVE COMPARATOR

Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section

Drug: Ringer's Lactate

CSEA colloid

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section

Drug: Six percent hydroxyethyl starch

Interventions

Ringer's Lactate DRUG

Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks

Also known as: Lactated Ringer's solution

CSEA crystalloid; Epidural crystalloid; Spinal crystalloid

Six percent hydroxyethyl starch DRUG

Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks

Also known as: HES/HAES

CSEA colloid; Epidural colloid; Spinal colloid

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First time of delivery
• ASA status I-II
• No premature
• No genetic and infectious diseases
• Chinese

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

CN (1)