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Trial registered on ANZCTR


Registration number
ACTRN12616000884404
Ethics application status
Approved
Date submitted
5/06/2016
Date registered
5/07/2016
Date last updated
26/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal hypotension during elective caesarean delivery under various spinal anaesthesia regimens
Scientific title
The incidence of maternal hypotension during elective caesarean delivery under spinal anesthesia in healthy ASA I pregnant women: comparison of intravenous ondansetron, continuous infusion of phenylephrine and ondansetron plus continuous infusion of phenylephrine with placebo. A double blind, randomized, placebo controlled trial.
Secondary ID [1] 289369 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
maternal hypotension during elective caesarean delivery under spinal anaesthesia 298997 0
Maternal nausea and vomiting 298998 0
Maternal dizziness 299181 0
Maternal unconsciousness 299182 0
Maternal pulmonary aspiration 299183 0
Maternal arrythmias 299184 0
Fetal acidosis 299185 0
Condition category
Condition code
Anaesthesiology 299061 299061 0 0
Anaesthetics
Reproductive Health and Childbirth 299191 299191 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The syringes have no identifying markers indicating group allocation. The nurse injects the contents of the 10 mL syringe intravenously over 60 s and starts the 50 mL syringe IV continuous infusion at 15 mL/h five minutes before the lumbar puncture is performed. The anaesthetist caring for the woman is blinded to group allocation.
Arm 1: ondansetron 8 mg with 0.9% saline solution (total volume 10 mL) intravenously over 60 s AND phenylephrine 10 mg with 0.9% saline solution to a total volume of 49 mL (50 mcg/min continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia
Arm 2: placebo of 0.9% saline solution 10 mL (administered intravenously over 60 s) AND phenylephrine 10 mg with 0.9% saline solution to a total volume of 49 mL (50 mcg/min continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia.
Arm 3: ondansetron 8 mg with 0.9% saline solution (total volume 10 mL, administered intravenously over 60 s), AND 0.9% saline solution 50 mL (continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia.
Arm 4: placebo of 0.9% saline solution 10 mL (administered intravenously over 60 s) AND 0.9% saline solution 50 mL (continuous infusion) at 15 mL/h, both administered 5 min prior to spinal anesthesia.
The duration of the continuous infusion for all arms is until end of procedure.
Intervention code [1] 294955 0
Treatment: Drugs
Intervention code [2] 294956 0
Prevention
Comparator / control treatment
It is very important to state that the control group (placebo) will receive all standardized cares internationally accepted for an elective cesarean delivery under spinal anesthesia. The other 3 groups, ondansetron, phenylephrine or ondansetron + phenylephrine are not an usual practice for all obstetric anesthesiologists, but the doses proposed in this study are accepted as the usual doses of these drugs for cesarean delivery under spinal anesthesia
Control group
Placebo

Outcomes
Primary outcome [1] 298535 0
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.
Systolic blood pressure will be assessed using electronic noninvasive blood pressure monitor with readings displayed on the monitoring screen
Timepoint [1] 298535 0
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.
Secondary outcome [1] 324508 0
diastolic blood pressure, measured with non invasive blood pressure monitor with readings displayed on the monitoring screen
Timepoint [1] 324508 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [2] 324924 0
mean arterial pressure, measured with non invasive blood pressure monitor with readings displayed on the monitoring screen
Timepoint [2] 324924 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [3] 324925 0
Heart rate, measured with automatic ECG monitor with readings displayed on the monitoring screen
Timepoint [3] 324925 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [4] 324926 0
oxygen saturation, measured with automatic pulseoximetry monitor with readings displayed on the monitoring screen
Timepoint [4] 324926 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [5] 324927 0
nausea is evaluated by means of a 4-point verbal descriptive scale (VDS) (0=no nausea, 1=mild, 2=moderate, 3=severe) and vomiting is valued visually by the anesthesiologist (existence or not of vomiting) in every time points checked)
Timepoint [5] 324927 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [6] 324928 0
Intraoperative valuation of all types of arrhythmias by the anesthesiologist, watching the monitor anesthesia and helped by the alarm system of electrocardiographic monitor of the anesthesia machine: tachyarrhythmias, bradyarrhythmias, abnormal QRS complex and P wave and ST and QT .segment alterations.
Timepoint [6] 324928 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [7] 324929 0
skin flushing, valued visually by means of the Global Flushing Severity Score (GFSS), reported on a 0–10 scale (none = 0, mild = 1–3, moderate = 4–6, severe = 7–9 and extreme = 10)
Timepoint [7] 324929 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [8] 324930 0
pruritus, valued asking the patient
Timepoint [8] 324930 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [9] 324931 0
discomfort, valued asking the patient
Timepoint [9] 324931 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [10] 324932 0
need for atropine, 0.01 mg/kg IV i the maternal heart rate is lower than 45 beats/min, valued intraoperatively by the anesthesiologist watching the anesthesia ECG monitor and helped by the alarm system of bradyarrhythmias of the electrocardiographic monitor of the anesthesia machine
Timepoint [10] 324932 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [11] 324933 0
need for ephedrine 10 mg IV if hypotension with heart rate lower than 95 beats/min, valued intraoperatively by the anesthesiologist watching the anesthesia ECG and not invasive blood pressure monitors and helped by the alarm systems of the anesthesia machine.
Hypotension, is defined in this study as a systolic blood pressure <75% of baseline, so the systolic blood pressure monitor alarm of hypotension is established according to this data
Timepoint [11] 324933 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [12] 324934 0
need for phenylephrine 50 microg if the maternal heart rate is higher than 95 beats/min, given over 30 s to avoid bradycardia.
Valued intraoperatively by the anesthesiologist watching the anesthesia ECG and not invasive blood pressure monitors and helped by the alarm systems of the anesthesia machine.
Hypotension, is defined in this study as a systolic blood pressure <75% of baseline, so the systolic blood pressure monitor alarm of hypotension is established according to this data
Timepoint [12] 324934 0
Basal (before administration of the study drug) and 1, 3, 5, 7, 9, 11, 13, 15, 20, 25, 30, 35, 40 and 45 min after intrathecal injection, as well as at the end of surgery.
Secondary outcome [13] 324935 0
Sensory block height level after spinal anesthesia will be checked by assessing the perception of coldness using an alcohol swab, and motor block using the Bromage scale
Timepoint [13] 324935 0
7 and 15 min after intrathecal injection.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be previously randomly allocated by our Statistical Department.
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our statistical Department has estimated the sample size of the study to guarantee with a significant level (alpha) of 0.05 in a two-sided test, a potency (1-beta) superior to 95% on detection of differences between means of at least 1 standardized clinical difference and has established a randomization protocol. Statistical method will study with I.B.M. SPSS software the normality of the quantitative parameters using Kolmogorov-Smirnov test. Comparison of means of independent samples will be performed using ANOVA, followed by Dunnett's test for post hoc testing, and repeated measures ANOVA will be used for paired data. Association between qualitative variables will be performed using the chi-square test with Fisher's exact test where appropriate. Trends will be studied with the chi-square for linear trend test. A P value <0.05 will be considered significant. Hemodynamic data (SBP, DBP, MAP, heart rate and oxygen saturation), will be re-plotted using a format where all values were expressed as the correspondent percentage related to the baseline value (considered as 100%) to reveal a more discrete pattern of change so that each patient served as her own control.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 7937 0
Spain
State/province [1] 7937 0
Madrid

Funding & Sponsors
Funding source category [1] 293748 0
Hospital
Name [1] 293748 0
University Hospital Gregorio Maranon
Country [1] 293748 0
Spain
Funding source category [2] 293857 0
Hospital
Name [2] 293857 0
University Hospital Puerta de Hierro Majadahonda
Country [2] 293857 0
Spain
Primary sponsor type
Hospital
Name
University Hospital Gregorio Maranon
Address
Dr. Esquerdo St. 46,
28007 Madrid
Country
Spain
Secondary sponsor category [1] 292577 0
Hospital
Name [1] 292577 0
University Hospital Puerta de Hierro Majadahonda
Address [1] 292577 0
Manuel de Falla St., 1,
28222 Majadahonda,
Madrid
Country [1] 292577 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295185 0
University Hospital Gregorio Maranon Clinical Research Ethics Committee (Comite Etico de Investigacion Clinica del Hospital General Universitario Gregorio Maranon)
Ethics committee address [1] 295185 0
Ethics committee country [1] 295185 0
Spain
Date submitted for ethics approval [1] 295185 0
28/03/2014
Approval date [1] 295185 0
30/04/2014
Ethics approval number [1] 295185 0
Codigo FP2014-01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66434 0
Dr Jose Ramon Ortiz Gomez
Address 66434 0
Department of Anesthesiology. Hospital Complex of Navarra.
Calle Irunlarrea, 3,
31008 Pamplona
Navarra.
Country 66434 0
Spain
Phone 66434 0
+34 848422222
Fax 66434 0
Email 66434 0
jortizgo@cfnavarra.es
Contact person for public queries
Name 66435 0
Jose Ramon Ortiz Gomez
Address 66435 0
Department of Anesthesiology. Hospital Complex of Navarra.
Calle Irunlarrea, 3,
31008 Pamplona
Navarra.
Country 66435 0
Spain
Phone 66435 0
+34 848422222
Fax 66435 0
Email 66435 0
jortizgo@cfnavarra.es
Contact person for scientific queries
Name 66436 0
Jose Ramon Ortiz Gomez
Address 66436 0
Department of Anesthesiology. Hospital Complex of Navarra.
Calle Irunlarrea, 3,
31008 Pamplona
Navarra.
Country 66436 0
Spain
Phone 66436 0
+34 848422222
Fax 66436 0
Email 66436 0
jortizgo@cfnavarra.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReducing by 50% the incidence of maternal hypotension during elective caesarean delivery under spinal anesthesia: Effect of prophylactic ondansetron and/or continuous infusion of phenylephrine - A double-blind, randomized, placebo controlled trial.2017https://dx.doi.org/10.4103/sja.SJA_237_17
N.B. These documents automatically identified may not have been verified by the study sponsor.