HypotensionNCT03834259
The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia
A study testing sitting position and supine position in people with Hypotension and Spinal Anaesthesia, run by Umraniye Education and Research Hospital.
Trial summary
The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Spinal Anaesthesia
- What is being tested?
- sitting position and supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2017
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18 - 45 years,
- ASA physical status
- I - II,
- BMI of 25-30
- who were undergoing elective CS
Who cannot join
- vertebral anomaly,
- peripheral vascular disease,
- cardiovascular or psychiatric disorder,
- severe anemia,
- coagulopathy
- infection in the intervention region
About this study
Official title: The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption
The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.
- Conditions
- Hypotension, Spinal Anaesthesia
- Being tested
- sitting position, supine position
- Keywords
- spinal anaesthesia, ephedrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitting positionProcedure or surgery
keeping the patient in a sitting position after spinal anaesthesia
supine positionProcedure or surgery
keeping the patient in supine position after spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 12.5 mg 0.5% hyperbaric bupivacaine Receives: Procedure: sitting position |
| Group 2 | Active comparator | 10 mg 0.5% hyperbaric bupivacaine Receives: Procedure: supine position |
| Group 3 | Active comparator | 12.5 mg 0.5% hyperbaric bupivacaine Receives: Procedure: supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic arterial hypotension
reduction of >25% in the basal systolic arterial pressure
Measured: every 3 minutes until the delivery and every 5 minutes until the end of surgery
Secondary outcomes (5)
sensory block
assesment of the time to reach T12 level with pin prick test
Measured: 10 minutes after spinal block
ephedrine requirement time
the time to first administration of ephedrine as minutes after spinal block
Measured: 1 hour after spinal block
amount of ephedrine
administrated total ephedrine dosage as mg during surgery
Measured: 1 hour after spinal block
surgeon and patient satisfaction
1= poor, 2=fair, 3= good, 4= very good
Measured: 24 hours after spinal block
motor block
time to Bromage Score 0 after applying spinal block
Measured: 24 hours after spinal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jan 2017
- Primary completion1 Nov 2017
- Study completion1 Dec 2017
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
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834259
- Sponsor's protocol ID
- GK12
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption
- ClinicalTrials.gov ID
- NCT03834259
- Acronym / sponsor ID
- GK12
- Conditions
- Hypotension, Spinal Anaesthesia
- Keywords
- spinal anaesthesia, ephedrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 7 Feb 2019 (actual)
- 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.
The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: sitting position12.5 mg 0.5% hyperbaric bupivacaine |
| Group 2 | Active comparator | Procedure: supine position10 mg 0.5% hyperbaric bupivacaine |
| Group 3 | Active comparator | Procedure: supine position12.5 mg 0.5% hyperbaric bupivacaine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18 - 45 years,
- ASA physical status
- I - II,
- BMI of 25-30
- who were undergoing elective CS
Key exclusion criteria (6 listed)
- vertebral anomaly,
- peripheral vascular disease,
- cardiovascular or psychiatric disorder,
- severe anemia,
- coagulopathy
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 |
|---|---|---|
| sitting positionkeeping the patient in a sitting position after spinal anaesthesia | Procedure or surgery | Group 1 |
| supine positionkeeping the patient in supine position after spinal anaesthesia | Procedure or surgery | Group 2, Group 3 |
Primary outcome
systolic arterial hypotension
Time frame: every 3 minutes until the delivery and every 5 minutes until the end of surgery
reduction of >25% in the basal systolic arterial pressure
5 secondary outcomes
sensory block
Time frame: 10 minutes after spinal block
ephedrine requirement time
Time frame: 1 hour after spinal block
amount of ephedrine
Time frame: 1 hour after spinal block
surgeon and patient satisfaction
Time frame: 24 hours after spinal block
motor block
Time frame: 24 hours after spinal block
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 7 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sitting position and supine position in people with Hypotension and Spinal Anaesthesia, run by Umraniye Education and Research Hospital.
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 5 inclusion and 6 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
systolic arterial hypotension (time frame: every 3 minutes until the delivery and every 5 minutes until the end of surgery). 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 7 Feb 2019.