NCT03834259

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 5, 2019

Last Update Submit

February 6, 2019

Conditions

HypotensionSpinal Anaesthesia

Keywords

spinal anaesthesiaephedrine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • sensory block

    10 minutes after spinal block

  • ephedrine requirement time

    1 hour after spinal block

  • amount of ephedrine

    1 hour after spinal block

  • surgeon and patient satisfaction

    24 hours after spinal block

  • motor block

    24 hours after spinal block

Study Arms (3)

Group 1

ACTIVE COMPARATOR

12.5 mg 0.5% hyperbaric bupivacaine

Procedure: sitting position

Group 2

ACTIVE COMPARATOR

10 mg 0.5% hyperbaric bupivacaine

Procedure: supine position

Group 3

ACTIVE COMPARATOR

12.5 mg 0.5% hyperbaric bupivacaine

Procedure: supine position

Interventions

sitting positionPROCEDURE

keeping the patient in a sitting position after spinal anaesthesia

Group 1
supine positionPROCEDURE

keeping the patient in supine position after spinal anaesthesia

Group 2Group 3

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe study was designed in caesarean section operations
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypotension

Interventions

Sitting PositionSupine Position

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 7, 2019

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

February 7, 2019

Record last verified: 2019-02