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Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Primary Purpose

Spinal Anesthesia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Epinephrine
Norepinephrine
Phenylephrine
Saline
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Anesthesia focused on measuring vasopressor, spinal anaesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-II physical status
  • Pregnant patients
  • Full term pregnant

Exclusion Criteria:

  • ASA III-IV physical status
  • Emergency status
  • Heart disease
  • Hypertension
  • Body mass index>25

Sites / Locations

  • Çukurova University Balcalı Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Epinephrine

Norepinephrine

Phenylephrine

Control

Arm Description

Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.

Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.

Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.

Saline infusion will apply at equivalent volume till the surgical operation

Outcomes

Primary Outcome Measures

Incidence of intraoperative maternal hypotension
The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP <90 mm Hg), the total number of hypotension episodes during surgery

Secondary Outcome Measures

Full Information

First Posted
May 11, 2017
Last Updated
October 22, 2019
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT03163914
Brief Title
Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension
Official Title
Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
Detailed Description
After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV. At the end of the study all collected data will use for statistically analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia
Keywords
vasopressor, spinal anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Partipicants and care providers will not known which medication will apply.
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epinephrine
Arm Type
Active Comparator
Arm Description
Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.
Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Description
Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.
Arm Title
Phenylephrine
Arm Type
Active Comparator
Arm Description
Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline infusion will apply at equivalent volume till the surgical operation
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
group I
Intervention Description
Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
group II
Intervention Description
Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
group III
Intervention Description
Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
group IV
Intervention Description
saline infusion will apply till the end of the surgery
Primary Outcome Measure Information:
Title
Incidence of intraoperative maternal hypotension
Description
The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP <90 mm Hg), the total number of hypotension episodes during surgery
Time Frame
At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I-II physical status Pregnant patients Full term pregnant Exclusion Criteria: ASA III-IV physical status Emergency status Heart disease Hypertension Body mass index>25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakkı Ünlügenç
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Çukurova University Balcalı Hospital
City
Adana
ZIP/Postal Code
01380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

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