Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT03163914

Collaborator

(none)

160

Enrollment

Location

Arms

9.2

Actual Duration (Months)

17.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia	Drug: Epinephrine Drug: Norepinephrine Drug: Phenylephrine Drug: Saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Partipicants and care providers will not known which medication will apply.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 19, 2017

Actual Primary Completion Date :

Apr 24, 2018

Actual Study Completion Date :

Apr 24, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incidence of intraoperative maternal hypotension [At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Çukurova University Balcalı Hospital	Adana		Turkey	01380

Sponsors and Collaborators

Cukurova University

Investigators

Study Director: Hakkı Ünlügenç, Cukurova University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ebru biricik, Dr, Cukurova University

ClinicalTrials.gov Identifier:

NCT03163914

Other Study ID Numbers:

Vasopressor

First Posted:

May 23, 2017

Last Update Posted:

Oct 24, 2019

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ebru biricik, Dr, Cukurova University

vasopressor

spinal anaesthesia

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2019