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

NCT01571791 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-09-04

No results posted yet for this study

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

Interventions

DRUG

Placebo

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

DRUG

Ketorolac-Lidocaine

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571791 on ClinicalTrials.gov