Sponsor study identifier
observational
60
1 country
1
Study Start
February 18, 2018
Actual (reported)Primary Completion
June 5, 2018
Actual (reported)Study Completion
June 10, 2018
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 10, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2018
Actual (reported)March 4, 2018
Actual (reported)March 9, 2018
Actual (reported)June 5, 2018
Actual (reported)June 10, 2018
Actual (reported)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
Hemodynamic monitoring
24 hours postoperative
Efficiency of BNP
24 hours postoperative
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Cairo University
Cairo, 1, Egypt
60 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2018
First Posted
March 9, 2018
Study Start
February 18, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 5, 2018
Actual (reported)Study Completion
June 10, 2018
Actual (reported)Last Updated
June 16, 2020
Record last verified: 2020-06
Population of study \& disease condition Following ethical committee approval, the study will be carried out on 30 parturient patients with cardiac disease undergoing cesarian section at Kasr El Ainy hospitals after obtaining the informed consent.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: