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

NCT03460184 | Completed DMC

• 1 other identifier: N-2-2018
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemodynamic monitoring

  24 hours postoperative

• Efficiency of BNP

  24 hours postoperative

Study Arms (2)

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:

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:

Interventions

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.

Also known as: Spinal A Group B:

G.A Group A; Spinal A Group B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Parturient cardiac patient undergoing cesarean section.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Parturient cardiac patient 20-50 years old undergoing cesarean section with * Mild to moderate valvular heart lesions. * Cardiomyopathic lesions with ejection fraction \> 40% * Ischemic heart disease * Hypertension * Non-fatal arrhythmias eg. Controlled AF

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cairo University

Cairo, 1, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 9, 2018
• Study Start: February 18, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 10, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)