NCT04010318

Brief Summary

  • Full term pregnant female patients presented for elective C.S for single viable fetus will be included in this study.
  • Before anesthesia, the patient will be attached to a monitor of: ECG , heart rate, non invasive blood pressure, pulse taximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and plethysmographic variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative.
  • Patients with PVI \<15 will be excluded from the study.
  • Patients with PVI \> 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI \<15 or a total 1 liter of ringer lactate.
  • The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group. After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

July 3, 2019

Last Update Submit

March 24, 2021

Conditions

Complication of Anaesthesia During Labour and Delivery

Outcome Measures

Primary Outcomes (1)

  • The incidence of post-spinal anesthesia hypotension

    The decrease in the mean arterial pressure below 65 mmHg or below 80% of the baseline value.

    Through out the whole intraoperative period

Secondary Outcomes (1)

  • The consumption of vasopressors

    Through out the whole intraoperative period

Study Arms (2)

Corrected group

The patients in which the PVI will corrected by fluid to level below 15

Procedure: Spinal Anesthesia

Uncorrected group

Patients in which intravenous fluid administration didn't result any change in PVI or changed but still higher than 15

Procedure: Spinal Anesthesia

Interventions

Spinal AnesthesiaPROCEDURE

The patients will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied.

Corrected groupUncorrected group

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Full term pregnant female patients presented for elective cesarean section delivery of a single viable fetus under spinal anesthesia/

You may qualify if:

  • Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.

You may not qualify if:

  • Patients with pregnancy less than 36 weeks or more than 40 weeks, Patients with hypertension , pre-eclampsia , eclampsia, Patients with diabetes, Patients with cardiovascular disease and /or arrhythmia, Patients with placenta previa , accreta, percreta, Obese patients with BMI \>36, or Polyhydramnious patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tanta University Hospitals

Tanta, Algharbia Governate, 31511, Egypt

Location

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Sameh Ismaiel, M.D

    Lecturer of Anesthesia and Intensive Care, Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

August 15, 2019

Primary Completion

February 11, 2021

Study Completion

February 11, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

EG(2)