Ideal Dose of Phenylephrine to Treat Low Blood Pressure D... | NCT00379691

Studies
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

NCT00379691

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Last Update Posted

Mar 21, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Hypotension
Nausea

Interventions

phenylephrine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
06-0186-E

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Sep 21, 2006

First Submission Date that Met QC Criteria

Sep 21, 2006

First Posted Date

Sep 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2007

Last Update Posted Date

Mar 21, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

Detailed Description

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be conducted in a randomized double-blinded fashion. This dose-response study will be conducted as per the up-down sequential allocation method, modified by the Narayana rule, designed to cluster the results around the ED95.

Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. Phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.Hypotension will be defined as a SBP less than 80 % of the baseline value, in which case the treatment will be a failure. Hypertension will be defined as a SBP more than 120 % of baseline value. If a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
phenylephrine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome will be the minimum dose of phenylephrine which effectively prevents both hypotension and nausea/vomiting between intrathecal injection of the local anesthetic and delivery of the fetus.

Secondary Outcomes

Measure	Description	Time Frame
Maternal Demographics: Maternal age-weight-height
Nausea and Vomiting
Time of intrathecal injection, skin incision, uterine incision, and delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective CS under spinal anesthesia
Normal singleton pregnancy beyond 36 weeks gestation
ASA physical status I/II
Weight 50-100 kg, height 150-180 cm
Age over 18 years

Exclusion Criteria:

Patient refusal
Allergy or hypersensitivity to phenylephrine
Preexisting or pregnancy-induced hypertension
Cardiovascular or cerebrovascular disease
Fetal abnormalities
History of diabetes, excluding gestational diabetes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose CA Carvalho, MD PhD	Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G 1X5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010656	Phenylephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided