NCT02828176

Brief Summary

The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

June 21, 2016

Last Update Submit

July 9, 2016

Conditions

Cardiac Output

Keywords

cardiometryuterine displacement

Outcome Measures

Primary Outcomes (2)

  • change in cardiac output (L/min) before anesthesia

    measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).

    baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees

  • change in cardiac output (L/min) after spinal anesthesia

    measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).

    baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees

Secondary Outcomes (2)

  • change in systemic vascular resistance (dyn.s/cm5)

    baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block

  • change in mean arterial blood pressure (mmHg)

    baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block

Interventions

electric cardiometryPROCEDURE

The following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance. these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )

IV line insertionPROCEDURE

two Iv lines are inserted and 500cc crystalloid is administered to parturient .

spinal anesthesia ( subarachnoid block )PROCEDURE

Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs

You may not qualify if:

  • BMI \> 35 Kg/m2
  • polyhydramnios
  • history of impaired cardiac contractility
  • valvular heart disease
  • cardiac arrhythmias
  • hypertensive pregnancy disorders
  • fetal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. No abstract available.

    PMID: 13055188BACKGROUND

  • Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553.

    PMID: 25603203BACKGROUND

  • Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.

    PMID: 23543552BACKGROUND

  • Hasanin A, Soryal R, Kaddah T, Raouf SA, Abdelwahab Y, Elshafaei K, Elsayad M, Abdelhamid B, Fouad R, Mahmoud D, Hassabelnaby Y. Hemodynamic effects of lateral tilt before and after spinal anesthesia during cesarean delivery: an observational study. BMC Anesthesiol. 2018 Jan 15;18(1):8. doi: 10.1186/s12871-018-0473-0.

    PMID: 29334907DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 11, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07