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

NCT01571791 | Suspended Phase 2 DMC

• 1 other identifier: R/41
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Valve Heart Disease; Elective Cesarean Delivery

Keywords

Ketorolac; lidocaine; valvular hear diseases; cesarean section

Outcome Measures

Primary Outcomes (1)

• hemodynamics

  changes in blood pressures and heart rate

  Baseline, intraoperative, an expected average of 1 hour

Secondary Outcomes (6)

• changes in fentanyl consumption

  intraoperative, an expected average of 1 hour

• perioperative bleeding

  intraoperative, an expected average of 1 hour, up to 24 hours after surgery

• neonatal outcome

  up to 24 hours after delivery

• uterine tone

  intraoperative, an expected average of 1 hour

• postoperative pain

  up to 24 after surgery

Study Arms (2)

group SF

PLACEBO COMPARATOR

either saline infusion and intravenous fentanyl boluses

Drug: Placebo

group KL

ACTIVE COMPARATOR

ketorolac-lidocaine infusion and intravenous saline boluses

Drug: Ketorolac-Lidocaine

Interventions

Placebo DRUG

to receive saline infusion and intravenous fentanyl boluses, at 30 min before induction of anesthesia

group SF

Ketorolac-Lidocaine DRUG

receive ketorolac-lidocaine infusion and intravenous saline boluses , at 30 min before induction of anesthesia

group KL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2012
• First Posted: April 5, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

EG (1)