Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

NCT ID: NCT01278238

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.

The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.

Detailed Description

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Conditions

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Caesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phenylephrine

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

Lower limb compression

Group Type ACTIVE_COMPARATOR

Lower limb compression

Intervention Type DEVICE

Tight bandaging of lower extremity up to hips with compression bandages

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Neither phenylephrine nor lower limb bandaging

Interventions

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Phenylephrine

Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

Intervention Type DRUG

Lower limb compression

Tight bandaging of lower extremity up to hips with compression bandages

Intervention Type DEVICE

Placebo

Neither phenylephrine nor lower limb bandaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

Exclusion Criteria

Any form of disease or anomalities:

Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anestesiavdelingen Baerum Sykehus

OTHER

Sponsor Role lead

Responsible Party

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Jana Christine Kuhn

Dr.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jana Christine Kuhn, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Bærum sykehus

Locations

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Bærum Sykehus

Rud, Akershus, Norway

Site Status

Countries

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Norway

Other Identifiers

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2009-013025-42

Identifier Type: -

Identifier Source: org_study_id

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