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CompletedNCT03834259Updated Feb 7, 2019

The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia

An interventional study of sitting position and supine position in Hypotension and Spinal Anaesthesia, sponsored by Umraniye Education and Research Hospital. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Umraniye Education and Research Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2017, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Hypotension
  • Spinal Anaesthesia

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Keywords

  • spinal anaesthesia
  • ephedrine
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In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 214 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged 18 - 45 years,
  • ASA physical status
  • I - II,
  • BMI of 25-30
  • who were undergoing elective CS

Exclusion criteria

Exclusion Criteria:

  • vertebral anomaly,
  • peripheral vascular disease,
  • cardiovascular or psychiatric disorder,
  • severe anemia,
  • coagulopathy
  • infection in the intervention region
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
214 participants (actual)

Study arms

  • Active comparator
    Group 1

    12.5 mg 0.5% hyperbaric bupivacaine

    Procedure: sitting position

  • Active comparator
    Group 2

    10 mg 0.5% hyperbaric bupivacaine

    Procedure: supine position

  • Active comparator
    Group 3

    12.5 mg 0.5% hyperbaric bupivacaine

    Procedure: supine position

Interventions

  • Proceduresitting position

    keeping the patient in a sitting position after spinal anaesthesia

  • Proceduresupine position

    keeping the patient in supine position after spinal anaesthesia

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What researchers measure

Primary outcomes

  1. systolic arterial hypotension

    reduction of \>25% in the basal systolic arterial pressure

    Time frame: every 3 minutes until the delivery and every 5 minutes until the end of surgery

Secondary outcomes

  1. sensory block

    assesment of the time to reach T12 level with pin prick test

    Time frame: 10 minutes after spinal block

  2. ephedrine requirement time

    the time to first administration of ephedrine as minutes after spinal block

    Time frame: 1 hour after spinal block

  3. amount of ephedrine

    administrated total ephedrine dosage as mg during surgery

    Time frame: 1 hour after spinal block

  4. surgeon and patient satisfaction

    1= poor, 2=fair, 3= good, 4= very good

    Time frame: 24 hours after spinal block

  5. motor block

    time to Bromage Score 0 after applying spinal block

    Time frame: 24 hours after spinal block

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03834259
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Gulsah Karaoren (associate professor, Umraniye Education and Research Hospital) — Principal investigator
First posted
Feb 7, 2019
Start date
Jan 1, 2017
Primary completion
Nov 1, 2017
Completion
Dec 1, 2017
Last update
Feb 7, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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