Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.
The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.|
- The dose of needed vasopressor (phenylephrine). [ Time Frame: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery. ] [ Designated as safety issue: Yes ]
- Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine). [ Time Frame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours). ] [ Designated as safety issue: Yes ]Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.
|Study Start Date:||May 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Intermittent pneumatic compression
With intermittent pneumatic compression of the lower extremities (Covidien / Kendall SCD ™ sequential compression systems) plus phenylephrine perfusion (usual treatment)in elective caesarean section under spinal anaesthesia.
Procedure: Elective caesarean section under spinal anaesthesia.
Patients with scheduled caesarean.
Active Comparator: Only pheniyephrine perfussion
No intermittent pneumatic compression of the lower extremities in elective caesarean section under spinal anaesthesia.
|Procedure: Elective caesarean section under spinal anaesthesia.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891175
|Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospital del Mar|
|Barcelona, Spain, 08003|
|Hospital Vall d'Hebron Hospital|
|Barcelona, Spain, 08035|