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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03460184

Collaborator

Mohamed, Ahmed A., M.D. (Other), Sahr Marzouk (Other), Heba Omar (Other), Michael Wahib Wadeed (Other)

Enrollment

Location

3.7

Actual Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia Versus Spinal Anesthesia on BNP Hormone Levels Preoperatively and Postoperatively in Parturient Cardiac Patient Undergoing C.S	Diagnostic Test: G.A Group A:

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 18, 2018

Actual Primary Completion Date :

Jun 5, 2018

Actual Study Completion Date :

Jun 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
G.A Group A Group A: n= 30 Parturiant patients will receive general anesthesia. General anesthesia will be conducted After pre-oxygenation for 3-5 minutes. 5% thiopental (5 mg/kg) will be administered intravenously over 30s, 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 as needed. After delivery of the fetus, fentanyl IV will be given 1ug/kg as analgesia and 20 IU oxytocin will be given by intravenous infusion .Reverse neuromuscular blockade as necessary at completion of surgery. Extubate when the patient is awake, the anesthesia is adequately reversed, and the patient is following commands	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. Other Names: Spinal A Group B:
Spinal A Group B Group B: n= 30 Parturiant patients will receive spinal anesthesia. In the sitting position and after complete aseptic precaution are taken, 2-3 ml of Lidocaine will be injected subcutaneously, spinal anesthesia will be performed at interspace L3-4 or L4-5, either via midline or paramedian approaches using 22 guage Quinke needle with the bevel directed laterally. 2.5 ml of hyperbaric bupivacaine 0.5% in addition to 25 μg fentanyl (0.5 ml) will be injected into the subarachnoid space after successful dural puncture and confirmation by barbotage. The patient will be put flat in the supine position with left uterine displacement using wedge under the right loin and the surgeon will be allowed to sterilize and wrap the field after confirmation of the solidity of the block its level. All patiens will be observed for cardiac complications in the form of non-fatal MI, arrhythmias and sudden cardiac death until discharged after at least 72h.	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. Other Names: Spinal A Group B:

Arm

Intervention/Treatment

G.A Group A

Group A: n= 30 Parturiant patients will receive general anesthesia. General anesthesia will be conducted After pre-oxygenation for 3-5 minutes. 5% thiopental (5 mg/kg) will be administered intravenously over 30s, 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 as needed. After delivery of the fetus, fentanyl IV will be given 1ug/kg as analgesia and 20 IU oxytocin will be given by intravenous infusion .Reverse neuromuscular blockade as necessary at completion of surgery. Extubate when the patient is awake, the anesthesia is adequately reversed, and the patient is following commands

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.

Other Names:

Spinal A Group B:

Spinal A Group B

Group B: n= 30 Parturiant patients will receive spinal anesthesia. In the sitting position and after complete aseptic precaution are taken, 2-3 ml of Lidocaine will be injected subcutaneously, spinal anesthesia will be performed at interspace L3-4 or L4-5, either via midline or paramedian approaches using 22 guage Quinke needle with the bevel directed laterally. 2.5 ml of hyperbaric bupivacaine 0.5% in addition to 25 μg fentanyl (0.5 ml) will be injected into the subarachnoid space after successful dural puncture and confirmation by barbotage. The patient will be put flat in the supine position with left uterine displacement using wedge under the right loin and the surgeon will be allowed to sterilize and wrap the field after confirmation of the solidity of the block its level. All patiens will be observed for cardiac complications in the form of non-fatal MI, arrhythmias and sudden cardiac death until discharged after at least 72h.

Diagnostic Test: G.A Group A:

Other Names:

Spinal A Group B:

Outcome Measures

Primary Outcome Measures

Monitoring changes in BNP [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 Outcome Measures

Hemodynamic monitoring [24 hours postoperative]
Monitor changes in hemodynamics in relation to type of anesthesiaM
Efficiency of BNP [24 hours postoperative]
Efficiency of BNP in detection of cardiac complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	1

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abdalla, Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT03460184

Other Study ID Numbers:

N-2-2018

First Posted:

Mar 9, 2018

Last Update Posted:

Jun 16, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 16, 2020