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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03834259
Other study ID # GK12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 1, 2017

Study information

Verified date February 2019
Source Umraniye Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date December 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- aged 18 - 45 years,

- ASA physical status

- I - II,

- BMI of 25-30

- who were undergoing elective CS

Exclusion Criteria:

- vertebral anomaly,

- peripheral vascular disease,

- cardiovascular or psychiatric disorder,

- severe anemia,

- coagulopathy

- infection in the intervention region

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
sitting position
keeping the patient in a sitting position after spinal anaesthesia
supine position
keeping the patient in supine position after spinal anaesthesia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Umraniye Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary systolic arterial hypotension reduction of >25% in the basal systolic arterial pressure every 3 minutes until the delivery and every 5 minutes until the end of surgery
Secondary sensory block assesment of the time to reach T12 level with pin prick test 10 minutes after spinal block
Secondary ephedrine requirement time the time to first administration of ephedrine as minutes after spinal block 1 hour after spinal block
Secondary amount of ephedrine administrated total ephedrine dosage as mg during surgery 1 hour after spinal block
Secondary surgeon and patient satisfaction 1= poor, 2=fair, 3= good, 4= very good 24 hours after spinal block
Secondary motor block time to Bromage Score 0 after applying spinal block 24 hours after spinal block
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