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Completed

NCT Number: NCT03460184

Effect of Different Types of Anesthesia on Perioperative Brain Natriuretic Peptide Levels in Parturient Cardiac Patient Undergoing Elective Cesarean Section

comparing the effect of general anesthesia versus spinal anesthesia on brain natruretic peptide hormone levels preoperatively and postoperatively in parturient cardiac patient undergoing cesarean section

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Key information

Conditions

General Anesthesia Versus Spinal Anesthesia on BNP Hormone Levels Preoperatively and Postoperatively in Parturient Cardiac Patient Undergoing C.S

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Cairo, 1, Egypt

About this study

In our study, investigators will detect changes in brain natruretic peptide (BNP) levels in parturient patients at risk undergoing cesarean section, in relation to type of anesthesia used, general anesthesia versus spinal anesthesia, in order to evaluate the safety of type of anesthesia used for this kind of patient.

It is very important to assess and predict risk in the cardiovascular system in such cases. A number of cardiac indexes for predicting risk have been developed like Goldman Multifactorial risk index, Eagle's risk index and Detsky's cardiac index. It is recommended to evaluate patients using these indexes and to institute preoperative medical treatment based on the results. These clinical scoring systems, although simple to use, are somewhat inconvenient and have limitations in their predictive value, whereas other cardiac investigations such as exercise or pharmacologic stress imaging are sensitive, but limited in practice by time and resources. Recently brain natriuretic peptide (BNP) was spotlighted as a predictor for diagnosing and predicting the prognosis of various heart diseases. BNP is a cardiac hormone that is synthesized by ventricular myocytes in response to ventricular dysfunction. Recent studies have demonstrated that elevated serum BNP levels predict first cardiovascular event and death in the general population. In addition, it has been reported that BNP measured before major surgery can be used as a predictor of postoperative cardiac complications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild to moderate valvular heart lesions.
  • Cardiomyopathic lesions with ejection fraction > 40%
  • Ischemic heart disease
  • Hypertension
  • Non-fatal arrhythmias eg. Controlled AF

Exclusion criteria

Cardiomyopathic lesions with EF less than 40% Tight stenotic lesions Severe regurgitant lesions Pregnancy induced hypertension Fatal arrhythmia eg. Ventricular tachycardia renal impairment Cr > 1.2 surgery related problems: operation longer than 3 hours patient resuscitation with > 3 litres blood loss more than 1 liter

Treatment and study plan

G.A Group A:

Diagnostic Test

G.A will be conducted After pre-oxygenation for 3-5 minutes. thiopental (5 mg/kg) will be administered I.V, followed by succinylcholine 1.5 mg/kg. After tracheal intubation, the patients will be ventilated with 100% oxygen. isoflurane 0.8% will be added, to maintain the anesthesia. Further neuromuscular block will be maintained by using atracurium . After delivery of the fetus, fentanyl IV will be given 1ug/kg as analgesia and 20 IU oxytocin will be given by I.V infusion .Reverse neuromuscular blockade as necessary at completion of surgery. Extubate when the patient is awake

In the sitting position and after complete asepsis , 2-3 ml of Lidocaine will be injected subcutaneously, spinal anesthesia will be performed at interspace L3-4 or L4-5, midline approaches using 22 guage Quinke needle . 2.5 ml of hyperbaric bupivacaine 0.5% in addition to 25 μg fentanyl will be injected into the subarachnoid space after successful dural puncture and confirmation by barbotage.

Other names: Spinal A Group B:

Primary outcomes

  1. Monitoring changes in BNP

    Time frame: 24 hours postoperative

    Monitoring changes in BNP level pre and postoperatively in relation to type of anesthesia to evaluate the safety of type of anesthesia used in cesarean section for parturient with cardiac diseas

Secondary outcomes

  1. Hemodynamic monitoring

    Time frame: 24 hours postoperative

    Monitor changes in hemodynamics in relation to type of anesthesiaM

  2. Efficiency of BNP

    Time frame: 24 hours postoperative

    Efficiency of BNP in detection of cardiac complications

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Heba Omar
  • Michael Wahib Wadeed
  • Mohamed, Ahmed A., M.D.
  • Sahr Marzouk

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.