Maternal hypotension during elective caesarean delivery under various spinal anaesthesia regimens

Phase 4

Recruiting

• Conditions: maternal hypotension during elective caesarean delivery under spinal anaesthesia; Maternal nausea and vomiting; Maternal dizziness; Maternal unconsciousness; Maternal pulmonary aspiration; Maternal arrythmias; Fetal acidosis; Anaesthesiology - Anaesthetics; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12616000884404
• Lead Sponsor: niversity Hospital Gregorio Maranon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

American Society of Anaesthesiologists class I women scheduled for lower segment caesarean delivery under spinal anesthesia enrolled during anesthesia consultation or early in the third trimester.
Written informed consent must be obtained from all patients to participate in this study.

Exclusion Criteria

Exclusion criteria included refusal to participate, contraindication to spinal anaesthesia, age less than 20 years or greater than 45 years, obesity (body mass index (BMI) at term greater than 30 kg/m2), any ASA physical status not equal to 1, previous fluid therapy and history of allergy to or side effects from ondansetron or phenylephrine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome, hypotension, is defined in this study as a systolic blood pressure <75% of baseline, using the criteria outlined in the Cochrane review of hypotension in obstetrics.<br>Systolic blood pressure will be assessed using electronic noninvasive blood pressure monitor with readings displayed on the monitoring screen[Systolic blood pressure will be recorded before administration of the study drug and the at 2 min intervals for 15 min and 5 min intervals for a further 30 min after intrathecal injection, as well as at the end of surgery.<br><br>]