Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EC 10/060
Study information
Scientific title
Prediction of hypotension caused by spinal block in caesarean section by the analysis of the activity of the autonomic nervous system, and the effects of pharmacological prophylaxis of hypotension on foetal well-being: a double-blinded prospective clinical trial
Acronym
Study hypothesis
Prophylaxis of hypotension with phenylephrine has negative effects on the pH of umbilical cord in not prone to develop hypotension pregnants, which offsets the potential positive impact of prevention on the pH of cord of patients prone to develop it. The hemodynamic stress of the decubitus supine position (supine stress test) can induce additional changes in the autonomic nervous system (ANS), which would improve the ability of Heart rate variability (HRV) analysis of prediction of the hypotension. The simultaneous study of different indicators and modes of analysis of the activity of the ANS and its variations between bed rest and supine stress will make it possible to identify the component of the spectrum of frequency variability and the indicator of better ability to prediction of the hypotension.
Ethics approval
The Clinical Research Ethics Committee of Aragon [Comité Ético de Investigación Clínica de Aragón (CEICA)], 27 July 2011 ref: C.I.EC10/060
Study design
Prospective clinical double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Caesarean section and hypotension after spinal block
Intervention
The interventions included in the clinical trial will be the following ones:
For the anaesthetic technique and management, the interventions included will be crystalloid preload with Ringer Lactate 1000 ml, puncture in site position in L3-4 or L2-3 with Withacre G25 or G27 needle, block with Bupivacaine 0.5% hyperbaric (10 mg in height <155cm, 11mg in height 155-165 cm, 12 mg in >165 cm) with 0.15 mg of morphic chlorure conservant free addition. Supine position with 45º left tilt. Maintenance of the venous with a Ringer Lactated infusion at 15 ml/kr-1min-1.
If the patient is assigned to treatment group, they will receive a parallel infusion of phenylephrine through an infusion bomb at 1 mlkg-1min-1 for the hypotension prophylaxis, and if the patient is assigned to control group will only receive a placebo infusion. The hypotension treatment will consist on an ephedrine intravenous bolus correction in both groups if necessary, with an initial 5 mg dose, and adding additional bolus if the hypotension does not stop.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The first part of the trial will study different indicators of the ANS (autonomic nervous system) activity and their arterial hypotension prediction capacity related to the caesarean intervention spinal anaesthesia
2. The ANS activity will be measured through HRV, PRV and Pulse Transit Time Variability (PTTV) and a digital register of the ECG curve
Secondary outcome measures
1. The second part of the trial is the study of the hypotension prophylaxis with phenylephrine effect in the foetal well-being. This will be measured through an arterial and venous blood sample from the umbilical cord to determinate gases, acid-base balance and lactic acid
2. Other measurements will be done, a register and evaluation of the maternal total antioxidant system (TAS), TAM, TAD, FC and oxygen saturation (Sat O2) at baseline and at 5 and 20 minutes of the epinephrine bolus infusion, the number of epinephrine bolus, dose and administration time and the times of epinephrine bolus initiation, uterine incision and foetal extraction
3. Nausea and vomiting (adverse effects)
Overall trial start date
13/12/2011
Overall trial end date
01/09/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women scheduled for caesarean section in first turn on the surgical part
2. Have given her informed consent to participate in the trial asked in the preanaesthetic consultation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Presence of uterine dynamics
2. Multiple pregnancies
3. Maternal pathology related or not with the gestation
4. Suspicion of foetal pathology
Recruitment start date
13/12/2011
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Spain
Trial participating centre
Seccion de Anestesia
Zaragoza
50009
Spain
Sponsor information
Organisation
Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
Sponsor details
Avenida Gómez Laguna 25
Planta 11
Zaragoza
50009
Spain
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary