Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia
• Intervention / Treatment: Drug: Epinephrine; Drug: Norepinephrine; Drug: Phenylephrine; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01380
    • Çukurova University Balcalı Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Epinephrine; Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.	Drug: Epinephrine; Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml ); Other Names: group I
ACTIVE_COMPARATOR: Norepinephrine; Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.	Drug: Norepinephrine; Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml ); Other Names: group II
ACTIVE_COMPARATOR: Phenylephrine; Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.	Drug: Phenylephrine; Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml ); Other Names: group III
PLACEBO_COMPARATOR: Control; Saline infusion will apply at equivalent volume till the surgical operation	Drug: Saline; saline infusion will apply till the end of the surgery; Other Names: group IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Study Director: Hakkı Ünlügenç, Cukurova University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2017
• Primary Completion (ACTUAL): April 24, 2018
• Study Completion (ACTUAL): April 24, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: spinal anaesthesia; vasopressor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Epinephrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: Vasopressor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No