Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery

• Status: Suspended
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Ketorolac; Ketorolac Tromethamine; Lidocaine

Criteria

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.