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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03460184
Other study ID # N-2-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 18, 2018
Est. completion date June 10, 2018

Study information

Verified date June 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 10, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
G.A Group A:
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.

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (5)

Lead Sponsor Collaborator
Cairo University Heba Omar, Michael Wahib Wadeed, Mohamed, Ahmed A., M.D., Sahr Marzouk

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Monitoring changes in BNP 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 24 hours postoperative
Secondary Hemodynamic monitoring Monitor changes in hemodynamics in relation to type of anesthesiaM 24 hours postoperative
Secondary Efficiency of BNP Efficiency of BNP in detection of cardiac complications 24 hours postoperative