Clinical Trials Logo
  1. Home
  2. Hypotension
  3. NCT04140058

Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

Hypotension Clinical Trial

Official title:
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04140058
Study type Interventional
Source University of Jordan
Contact
Status Completed
Phase Phase 3
Start date January 2, 2016
Completion date January 2, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting NCT02016599 - Effects of Transitional Circulation in ELBW Infants
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Recruiting NCT02532270 - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring N/A
Completed NCT02437799 - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia N/A
Completed NCT02802683 - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery Phase 4
Completed NCT02146898 - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery N/A
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Completed NCT01930227 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients N/A
Recruiting NCT01434251 - Treatment of Hypotension of Prematurity (TOHOP) N/A
Withdrawn NCT01183741 - Accuracy of Non-Invasive Blood Pressure Measurement in Adults Phase 3
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Withdrawn NCT00750516 - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Recruiting NCT05513066 - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed NCT04089644 - Manual vs Closed-loop Control of Mean Arterial Pressure N/A