Valve Heart Disease Clinical Trial
Official title:
A Randomized Study of the Effects of Perioperative i.v. Ketorolac-lidocaine on the Hemodynamic Response in the Patients With Valvular Heart Diseases During Cesarean Delivery
NCT number | NCT01571791 |
Other study ID # | R/41 |
Secondary ID | |
Status | Suspended |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | March 2022 |
Verified date | September 2020 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rheumatic heart valve diseases are prevalent among the young people in Egypt secondary to the
socioeconomic conditions. The goal of anesthetic management of these patients is maintenance
of sinus rhythm, systemic blood pressure, preload, coronary perfusion, and cardiac output.
Many women still prefer general anesthesia rather than regional techniques at the author's
country.
The pharmacological modifications of the sympathetic response to tracheal intubation and
surgical stimulation using opioids have adverse effects on the neonatal outcome after
cesarean delivery. The authors have demonstrated in their previous studies the safety of both
perioperative infusion of both of ketorolac and lidocaine in the attenuation of the
hemodynamic and hormonal responses of tracheal intubation and surgery during cesarean
delivery with favorable neonatal outcome and without added risk of perioperative bleeding.
Therefore, the authors reported successful anesthetic management of a parturient with
infective endocarditis on top of rheumatic mitral valve disease with use of
paracetamol-lidocaine-ketorolac-propofol anesthesia.
The investigators hypothesize that the perioperative use of ketorolac-lidocaine would reduce
the maternal hemodynamic responses to intubation and surgery without any harmful effects on
mother or baby during uncomplicated cesarean delivery in the parturients with valvular hear
diseases.
The investigators are aiming to compare the effects of ketorolac-lidocaine and fentanyl on
surgical stress responses, intraoperative fentanyl and vasoactive drugs consumption and
neonatal outcome during cesarean delivery in the parturients with valvular hear diseases.
Status | Suspended |
Enrollment | 90 |
Est. completion date | March 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 90 ASA II & IV women - with documented valvular heart disease - uncomplicated - singleton pregnancies of at least 36 weeks' gestation - scheduled for elective cesarean delivery - under general anesthesia Exclusion Criteria: - history of un-controlled hypertension - ischemic heart disease - left-ventricular ejection fraction less than 45% - severe pulmonary hypertension - critical aortic stenosis - peripheral vascular disease - thyrotoxicosis - neurological diseases - hepatic diseases w - renal diseases - allergy - those requiring preoperative inotropic, vasopressor, - mechanical circulatory or ventilatory support - pregnancy-induced hypertension - evidence of intrauterine growth restriction - fetal compromise. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Hospitals | Mansoura | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hemodynamics | changes in blood pressures and heart rate | Baseline, intraoperative, an expected average of 1 hour | |
Secondary | changes in fentanyl consumption | Intraoperative fentanyl consumption | intraoperative, an expected average of 1 hour | |
Secondary | perioperative bleeding | Intra-operative blood loss will be assessed by measuring blood in the suction bottle minus the sonographically estimated amniotic fluid volume, visual estimate of blood on drapes and floor and weighing swabs after use. Postoperative transfusion requirements and blood loss will be estimated as previously reported by Huang et al. from inspection of the perineal pad (0: small; 1: moderate; 2: large). Haematocrit values will be recorded before and 48 h after surgery. | intraoperative, an expected average of 1 hour, up to 24 hours after surgery | |
Secondary | neonatal outcome | Neonatal umbilical artery and umbilical vein blood pH, gas tensions, and base excess values. Apgar scores at 1 and 5 min, and newborns' blood pressure, heart rate, temperature, arterial oxygen saturation, and the Neurologic and Adaptive Capacity Score (NACS) will be recorded at 15 min, 2 and 24 h after delivery. |
up to 24 hours after delivery | |
Secondary | uterine tone | The obstetrician will assess uterine tone by palpation every 5 minutes after delivery of the placenta using a 10-cm VAS (0: well contracted; 10: completely relaxed). If uterine tone remains unsatisfactory after 3 min, an additional 5 U bolus of oxytocin will be administered. | intraoperative, an expected average of 1 hour | |
Secondary | postoperative pain | a 10-cm VAS at rest and on movement (0: no pain; 10: worst pain imaginable) 0, 1, 2, 4, 6, 8, 10 and 12 h after surgery. For postoperative pain relief intravenous 100 mg will be given when VAS scores are 5 or more at rest, or 7 or more on movement, or if the patient requests additional analgesia. The time to first request for analgesia and the number of subjects receiving tramadol during the first 12 h will be recorded. | up to 24 after surgery | |
Secondary | perioperative side effects | perioperative side effects includes arrhythmia, sedation, nausea and vomiting, light-headedness, headache, perioral numbness, tunnel vision, or seizures | up to 24 after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06066970 -
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
|
||
Recruiting |
NCT05079672 -
Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery
|
Phase 4 | |
Completed |
NCT03347851 -
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
|
||
Active, not recruiting |
NCT03539458 -
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
|
N/A | |
Completed |
NCT04328090 -
Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship
|
N/A | |
Recruiting |
NCT04359030 -
Freestyle-Perimount Calcification Comparison
|
||
Completed |
NCT04958668 -
Prospective Evaluation of Volatile Sedation After Heart Valve Surgery
|
N/A | |
Completed |
NCT04598360 -
Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)
|
N/A | |
Not yet recruiting |
NCT04118621 -
Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
|
||
Recruiting |
NCT06387446 -
Allogeneic Valve Transplantation
|
N/A | |
Recruiting |
NCT04843072 -
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
|
N/A | |
Completed |
NCT05804500 -
RecoveryPlus Telerehab Platform Pilot Study
|
N/A | |
Recruiting |
NCT03885180 -
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
|
N/A | |
Completed |
NCT06154018 -
Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.
|
N/A | |
Recruiting |
NCT06041308 -
Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
|
||
Completed |
NCT06261788 -
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
|
N/A | |
Completed |
NCT06079008 -
The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
|
||
Completed |
NCT04372654 -
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
|
N/A | |
Active, not recruiting |
NCT03661398 -
Caisson Transcatheter Mitral Valve Replacement (TMVR)
|
N/A | |
Recruiting |
NCT03595423 -
SPAnish Aortic VALVE Multicentric Study
|