PregnancyNCT02883075
Measurement of Hemodynamic Variables Under Spinal Anesthesia With Varied Positioning
A study testing Supine position, Right lateral position and Left lateral position in people with Pregnancy and Anesthesia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Anesthesia
- What is being tested?
- Supine position, Right lateral position and Left lateral position
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 26 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parturients undergoing elective cesarean section under spinal anesthesia
- Singleton intrauterine pregnancy with appropriate gestational age fetus (AGA) at gestational age 37 to 42 weeks
Who cannot join
- Large for gestational age, small for gestational age, and multiple gestations
- Patients with cardiovascular disease like hypertension, etc.
- Non-English or non-Spanish speakers
- BMI >40
- Inadequate or failed blocks and inadvertently high levels of spinal blockade will be dropped from the study
- Incarcerated parturients
- Expected heavy bleeding (placenta accreta, vascular anomaly, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Hemodynamic Variables Under Spinal Anesthesia in a Patient Undergoing Cesarean Section With Varied Positioning - a Comparative Study
Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability.
Investigators propose that following spinal placement in the sitting position if the patient is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic changes caused by sympathectomy related to the subarachnoid block can be avoided.
This is the first study to examining the influence of position changes after spinal anesthetic placement in the sitting position, which includes hemodynamic variables not previously studied including cardiac output, TPR (total peripheral resistance) and pulse pressure variation (PPV).
Read the detailed description
Cesarean section is chosen when natural spontaneous vaginal delivery is either not possible or when the health of the baby or mother is compromised. Cesarean section may be planned, urgent, or performed emergently when the life of the baby or mother is threatened.
Cesarean section is performed using different anesthetic techniques including: spinal, epidural, combined spinal and epidural, and general anesthesia. Spinal anesthesia is the most common technique chosen due to its relative safety, rapid onset and avoidance of potential complications from general anesthesia. It is the technique of choice for elective cesarean section unless contraindicated. Spinal anesthesia causes sympathetic blockade followed by sensory and motor blockade. Nerve fiber size explains the speed of onset and differential block. The critical moments during spinal anesthesia come as soon as local anesthetic is injected into the subarachnoid space.
- Conditions
- Pregnancy, Anesthesia
- Being tested
- Supine position, Right lateral position, Left lateral position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionOther
Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration
Right lateral positionOther
Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration
Left lateral positionOther
Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Sham comparator | Supine position Supine position after placement of spinal anesthetic Receives: Other: Supine position |
| Right lateral position | Active comparator | Right lateral position Right lateral after placement of spinal anesthetic Receives: Other: Right lateral position |
| Left lateral position | Active comparator | Left lateral position Left lateral after placement of spinal anesthetic Receives: Other: Left lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Continuous Heart rate (beats per minute) measurements.
Measured: Immediately before spinal anesthestic placement through placental delivery
Blood pressure
Continuous Blood pressure (mmHg) measurements
Measured: Immediately before spinal anesthetic placement through placental delivery
Secondary outcomes (7)
Incidence of nausea and vomiting
Nausea and vomiting incidence and anti-emetic administration with time stamps will be documented.
Measured: Number of events spinal anesthetic placement through placental delivery
Anti-emetic medication
Anti-emetic administration with time stamps will be documented.
Measured: Number of events spinal anesthetic placement through placental delivery
Incidence of vasopressor usage
Number of vasopressor use events will be monitored and recorded.
Measured: Spinal anesthetic placement through placental delivery
Total vasopressor usage
All vasopressor administrations with time stamps will be documented.
Measured: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: cardiac output
Continuous Cardiac output (L/min) measurements
Measured: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: stroke volume
Continuous Stroke volume (mL) measurements
Measured: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)
Continuous TPR (total peripheral resistance, dynes*sec/cm3)measurements
Measured: Spinal anesthetic placement through placental delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start1 Aug 2017
- Primary completion26 Sep 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranganathan Govindaraj, MD, FRCA, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883075
- Sponsor's protocol ID
- IRB #16-0119
- Status last verified
- Nov 2018
- First submitted
- 21 Jul 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Hemodynamic Variables Under Spinal Anesthesia in a Patient Undergoing Cesarean Section With Varied Positioning - a Comparative Study
- ClinicalTrials.gov ID
- NCT02883075
- Acronym / sponsor ID
- IRB #16-0119
- Conditions
- Pregnancy, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability.
Investigators propose that following spinal placement in the sitting position if the patient is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic changes caused by sympathectomy related to the subarachnoid block can be avoided.
This is the first study to examining the influence of position changes after spinal anesthetic placement in the sitting position, which includes hemodynamic variables not previously studied including cardiac output, TPR (total peripheral resistance) and pulse pressure variation (PPV).
Detailed description
Cesarean section is chosen when natural spontaneous vaginal delivery is either not possible or when the health of the baby or mother is compromised. Cesarean section may be planned, urgent, or performed emergently when the life of the baby or mother is threatened.
Cesarean section is performed using different anesthetic techniques including: spinal, epidural, combined spinal and epidural, and general anesthesia. Spinal anesthesia is the most common technique chosen due to its relative safety, rapid onset and avoidance of potential complications from general anesthesia. It is the technique of choice for elective cesarean section unless contraindicated. Spinal anesthesia causes sympathetic blockade followed by sensory and motor blockade. Nerve fiber size explains the speed of onset and differential block. The critical moments during spinal anesthesia come as soon as local anesthetic is injected into the subarachnoid space.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine position | Sham comparator | Other: Supine positionSupine position Supine position after placement of spinal anesthetic |
| Right lateral position | Active comparator | Other: Right lateral positionRight lateral position Right lateral after placement of spinal anesthetic |
| Left lateral position | Active comparator | Other: Left lateral positionLeft lateral position Left lateral after placement of spinal anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parturients undergoing elective cesarean section under spinal anesthesia
- Singleton intrauterine pregnancy with appropriate gestational age fetus (AGA) at gestational age 37 to 42 weeks
Key exclusion criteria (7 listed)
- Large for gestational age, small for gestational age, and multiple gestations
- Patients with cardiovascular disease like hypertension, etc.
- Non-English or non-Spanish speakers
- BMI >40
- Inadequate or failed blocks and inadvertently high levels of spinal blockade will be dropped from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine positionSpinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration | Other | Supine position |
| Right lateral positionSpinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration | Other | Right lateral position |
| Left lateral positionSpinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration | Other | Left lateral position |
Primary outcome
Heart rate
Time frame: Immediately before spinal anesthestic placement through placental delivery
Continuous Heart rate (beats per minute) measurements.
Blood pressure
Time frame: Immediately before spinal anesthetic placement through placental delivery
Continuous Blood pressure (mmHg) measurements
7 secondary outcomes
Incidence of nausea and vomiting
Time frame: Number of events spinal anesthetic placement through placental delivery
Anti-emetic medication
Time frame: Number of events spinal anesthetic placement through placental delivery
Incidence of vasopressor usage
Time frame: Spinal anesthetic placement through placental delivery
Total vasopressor usage
Time frame: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: cardiac output
Time frame: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: stroke volume
Time frame: Spinal anesthetic placement through placental delivery
Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)
Time frame: Spinal anesthetic placement through placental delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranganathan Govindaraj, MD, FRCA principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position, Right lateral position and Left lateral position in people with Pregnancy and Anesthesia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Immediately before spinal anesthestic placement through placental delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.