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

Primary Purpose

Hypotension, Spinal Anaesthesia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

sitting position

supine position

About this trial

This is an interventional prevention trial for Hypotension focused on measuring spinal anaesthesia, ephedrine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

12.5 mg 0.5% hyperbaric bupivacaine

10 mg 0.5% hyperbaric bupivacaine

12.5 mg 0.5% hyperbaric bupivacaine

Outcomes

Primary Outcome Measures

systolic arterial hypotension

reduction of >25% in the basal systolic arterial pressure

Secondary Outcome Measures

sensory block

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

ephedrine requirement time

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

amount of ephedrine

administrated total ephedrine dosage as mg during surgery

surgeon and patient satisfaction

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

motor block

time to Bromage Score 0 after applying spinal block

Full Information

NCT ID

NCT03834259

First Posted

February 5, 2019

Last Updated

February 6, 2019

Sponsor

Umraniye Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03834259

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

November 1, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umraniye Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension, Spinal Anaesthesia

Keywords

spinal anaesthesia, ephedrine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

12.5 mg 0.5% hyperbaric bupivacaine

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

10 mg 0.5% hyperbaric bupivacaine

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

12.5 mg 0.5% hyperbaric bupivacaine

Intervention Type

Procedure

Intervention Name(s)

sitting position

Intervention Description

keeping the patient in a sitting position after spinal anaesthesia

Intervention Type

Procedure

Intervention Name(s)

supine position

Intervention Description

keeping the patient in supine position after spinal anaesthesia

Primary Outcome Measure Information:

Title

systolic arterial hypotension

Description

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 Outcome Measure Information:

Title

sensory block

Description

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

Time Frame

10 minutes after spinal block

Title

ephedrine requirement time

Description

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

Time Frame

1 hour after spinal block

Title

amount of ephedrine

Description

administrated total ephedrine dosage as mg during surgery

Time Frame

1 hour after spinal block

Title

surgeon and patient satisfaction

Description

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

Time Frame

24 hours after spinal block

Title

motor block

Description

time to Bromage Score 0 after applying spinal block

Time Frame

24 hours after spinal block

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

the study was designed in caesarean section operations

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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