HypotensionNCT02253381
Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section
A study testing Right and Left in people with Hypotension, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Right and Left
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to Mar 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent
- Term pregnancy
- Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
Who cannot join
- Contraindication for spinal anesthesia
- Height < 150 cm.
- Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus, twin, abrupt placenta, placenta pre via, and fetal distress
- Failed spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial
Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena cava that may decrease venous return and cardiac output. This leads to hypotension.The hypothesis is the right lateral position during spinal anesthesia in pregnant women will be had hemodynamic changing more than the left lateral position. This objective is to compare hemodynamic change between left and right lateral position during spinal anesthesia in pregnant women undergoing cesarean section.
Read the detailed description
Study design: A randomized controlled trial
Study setting:
The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
Study period:
The total duration of participation in the randomized study is up to the operative day.
Study population:
Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml.
Study sample:
Inclusion criteria
- Signed informed consent
- Pregnancy
- Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
- Elective and emergency surgery
Exclusion criteria
- Contraindication for spinal anesthesia
- Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress, abruption placenta, twin pregnancy, and placenta previa totalis
- Maternal height < 150 cm.
- Conditions
- Hypotension
- Being tested
- Right, Left
- Keywords
- lateral decubitus position, hypotension, cesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RightProcedure or surgery
Right lateral decubitus position during spinal anesthesia
LeftProcedure or surgery
Left lateral decubitus position during spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Right lateral decubitus position | Active comparator | Right lateral decubitus position during spinal anesthesia Receives: Procedure: Right |
| Left lateral decubitus position | Active comparator | Left lateral decubitus position during spinal anesthesia Receives: Procedure: Left |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline
Measured: after bupivacaine injection until 15 minutes after spinal anesthesia
Secondary outcomes (2)
Ephedrine consumption
Total amount of ephedrine receiving
Measured: intraoperative
Apgar score at first minute and fifth minute
Measured: Child delivery at first minute and fifth minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panthila Rujirojindakul, Prince of Songkla University
- Investigators
- Boonsin Tangtrakulwanish, MD, Study chair, Ethical Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253381
- Sponsor's protocol ID
- REC: 57-195-08-1
- Status last verified
- Apr 2015
- First submitted
- 27 Sep 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial
- ClinicalTrials.gov ID
- NCT02253381
- Acronym / sponsor ID
- REC: 57-195-08-1
- Conditions
- Hypotension
- Keywords
- lateral decubitus position, hypotension, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Oct 2014 (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.
Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena cava that may decrease venous return and cardiac output. This leads to hypotension.The hypothesis is the right lateral position during spinal anesthesia in pregnant women will be had hemodynamic changing more than the left lateral position. This objective is to compare hemodynamic change between left and right lateral position during spinal anesthesia in pregnant women undergoing cesarean section.
Detailed description
Study design: A randomized controlled trial
Study setting:
The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
Study period:
The total duration of participation in the randomized study is up to the operative day.
Study population:
Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml.
Study sample:
Inclusion criteria
- Signed informed consent
- Pregnancy
- Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
- Elective and emergency surgery
Exclusion criteria
- Contraindication for spinal anesthesia
- Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress, abruption placenta, twin pregnancy, and placenta previa totalis
- Maternal height < 150 cm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right lateral decubitus position | Active comparator | Procedure: RightRight lateral decubitus position during spinal anesthesia |
| Left lateral decubitus position | Active comparator | Procedure: LeftLeft lateral decubitus position during spinal anesthesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Term pregnancy
- Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
Key exclusion criteria (4 listed)
- Contraindication for spinal anesthesia
- Height < 150 cm.
- Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus, twin, abrupt placenta, placenta pre via, and fetal distress
- Failed spinal anesthesia
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 |
|---|---|---|
| RightRight lateral decubitus position during spinal anesthesia | Procedure or surgery | Right lateral decubitus position |
| LeftLeft lateral decubitus position during spinal anesthesia | Procedure or surgery | Left lateral decubitus position |
Primary outcome
Hypotension
Time frame: after bupivacaine injection until 15 minutes after spinal anesthesia
Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline
2 secondary outcomes
Ephedrine consumption
Time frame: intraoperative
Apgar score at first minute and fifth minute
Time frame: Child delivery at first minute and fifth minute
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 29 Apr 2015.
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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.
Boonsin Tangtrakulwanish, MD study chair
Ethical Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right and Left in people with Hypotension, run by Prince of Songkla University at 1 site in Thailand.
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 3 inclusion and 4 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 29 Apr 2015. 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 Thailand. 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. 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?
Hypotension (time frame: after bupivacaine injection until 15 minutes after spinal anesthesia). 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 29 Apr 2015.