Plethysmographic Variability Index in Post Spinal Anesthesia Hypotension in Cesarean Section

The Sensitivity of Goal Plethysmography Variability Index (PVI) Directed Pre-anesthesia Intravenous Fluid Infusion in the Prevention of Spinal Anesthesia Induced Hypotension in Elective Caesarian Section: Prospective Observational Study

• 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,

Study Overview

• Status: Completed
• Conditions: Complication of Anaesthesia During Labour and Delivery
• Intervention / Treatment: Procedure: Spinal Anesthesia

Detailed Description

• This prospective observational study will be carried out on all pregnant women who will undergo elective cesarean section in obstetric department in Tanta university hospitals under spinal anesthesia over four month duration that starts immediately after obtaining ethical committee approval, an informed written consent will be included with the consent for spinal anesthesia for cesarean section, all patients data will be confidential and will be used for the current study only.
• Inclusion criteria:

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

• Exclusion criteria:

  • 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
  • Polyhydramnious patients
• On arrival of patients to pre-anaesthesia preparation room, we will allow patients to rest in supine position with 15 degree left tilt by pillow wedge under right hip, after allowing patient to rest for five minutes, measures are recorded: ECG , heart rate, non invasive blood pressure, pulse oximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and Plethysmography 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 are 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, supplemental oxygen at rate of 4 liter/minute is applied.

Measurements will be taken every minute till delivery of the baby, and if the blood pressure is decreased below 20% of the baseline level before anesthesia, patients will be given incremental doses of ephedrine sulfate 0.1 mg /kg till blood pressure normalized above 80% of pre-anesthesia level. All measurements will be recorded in tables and subjected to statistical analysis.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31511
    • Tanta University Hospitals
  • Algharbia Governate
    • Tanta, Algharbia Governate, Egypt, 31511
      • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Corrected group; The patients in which the PVI will corrected by fluid to level below 15	Procedure: Spinal Anesthesia; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The consumption of vasopressors	The total dose of ephedrine required to maintain the MAP above 80% of the baseline value	Through out the whole intraoperative period

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Tamer Mohamed Naguib; Amr Ahmed Magdy

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2019
• Primary Completion (ACTUAL): February 11, 2021
• Study Completion (ACTUAL): February 11, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 33109/05/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.

Drug and device information, study documents

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