Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT04140058
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2019-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section
Sponsor:
University of Jordan
Organization:
Study Overview
Official Title:
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients.
The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.
The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.
Detailed Description:
This prospective randomized double-blind placebo-controlled study will include 150 American Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for elective caesarean delivery under spinal anaesthesia.
Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.
Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction.
Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.
Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.
Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction.
Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: