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The effects of remifentanil on maternal hemodynamic, oxidative stress and neonatal outcome: comparison of two dosing regimens used during the induction-delivery period of caesarean section performed under general anesthesia

The effects of remifentanil on maternal hemodynamic, oxidative stress and neonatal outcome: comparison of two dosing regimens used during the induction-delivery period of caesarean section performed under general anesthesia - Maternal and fetal effects of remifentanil used during caesarean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015114
Enrollment
51
Registered
2018-07-30
Start date
2015-05-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic and oxidative stress response to anesthesia and surgery during elective caesarean section

Interventions

Group 1: Utiva (remifentanil), 1 µg/kg iv bolus followed by infusion 0.15 µg/kg/min Group 2: Utiva (remifentanil), 1 µg/kg iv bolus before the induction to anesthesia Group 3: patients who are not giv

Sponsors

Clinic of Gynaecology and Obstetrics University Clinical Center Nis
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 35 Years

Inclusion criteria

Inclusion criteria: Patients ASA I and II status, scheduled for elective caesarean section in general anesthesia who have given written informed consent. All patients refuse or have absolute/relative medical contraindications to regional anesthesia.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: known cardiac, respiratory, neurologic, renal, endocrine, psychiatric disorders, history of drug or alcohol abuse, morbid obesity, preeclampsia, predicted difficult airway management, active labor, known fetal congenital abnormalities or signs of fetal compromise.

Design outcomes

Primary

MeasureTime frame
Our main goal is to compare the changes of maternal blood pressure, heart rate values measured after endotracheal intubation, skin incision, peritoneal incision and delivery during caesarean cestion between groups that were under different remifentanil dosing regimens and to investigate the effect of those regimens on oxidative stress.

Secondary

MeasureTime frame
We also compare neonatal outcome between groups (Apgar scores at 1st and 5th minute, HR, oxygen saturation, the need for resuscitative measures and umbilical venous and arterial blood gas values).

Countries

Serbia

Contacts

Public ContactMarija Kutlesic

Clinic of Gynaecology and Obstetrics University Clinical Centre Nis

mkutlesic5@gmail.com**381 64 2302324

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026