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Plethysmographic Variability Index in Post Spinal Anesthesia Hypotension in Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010318
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Tamer Mohamed Naguib
Amr Ahmed Magdy
Information provided by (Responsible Party):
Sameh Abdelkhalik Ahmed Ismaiel, Tanta University

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,


Condition or disease Intervention/treatment
Complication of Anaesthesia During Labour and Delivery 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: 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
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 14, 2020
Estimated Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The incidence of post-spinal anesthesia hypotension [ Time Frame: Through out the whole intraoperative period ]
    The decrease in the mean arterial pressure below 65 mmHg or below 80% of the baseline value.


Secondary Outcome Measures :
  1. The consumption of vasopressors [ Time Frame: Through out the whole intraoperative period ]
    The total dose of ephedrine required to maintain the MAP above 80% of the baseline value



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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/
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010318


Contacts
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Contact: Sohair Soliman, Professor 00201283929049 sohairsoliman@hotmail.com
Contact: Mohamed Aly, M.D 00201099957971 moh_aly_2005@hotmail.com

Locations
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Egypt
Tanta University Hospitals Recruiting
Tanta, Algharbia Governate, Egypt, 31511
Contact: Sameh Abdelkhalik, M.D    00201002977048    samehabdelkhalik1982@gmail.com   
Contact: Eman Taher       emantaher6669@gmail.com   
Tanta University hospitals Recruiting
Tanta, Egypt, 31511
Contact: Sohair Soliman, Professor    00201283929049    sohairsoliman@hotmail.com   
Contact: Mohamed Abduallah, M.D    00201099957971    moh_aly_2005@hotmail.com   
Tanta University Hospitals Recruiting
Tanta, Egypt, 31511
Contact: Eman Taher       emantaher6669@gmail.com   
Sponsors and Collaborators
Tanta University
Tamer Mohamed Naguib
Amr Ahmed Magdy
Investigators
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Principal Investigator: Sameh Ismaiel, M.D Lecturer of Anesthesia and Intensive Care, Tanta University
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Responsible Party: Sameh Abdelkhalik Ahmed Ismaiel, Dr, Tanta University
ClinicalTrials.gov Identifier: NCT04010318    
Other Study ID Numbers: 33109/05/19
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once the study had been successfully completed, the data will be shared for other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs