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The use of remifentanil for attenuation of maternal pressor response to endotracheal intubation and surgical incision during the induction-delivery period of caesarean section performed under general anesthesia: comparison of two dosing regimens

The use of remifentanil for attenuation of maternal pressor response to endotracheal intubation and surgical incision during the induction-delivery period of caesarean section performed under general anesthesia: comparison of two dosing regimens - Maternal and fetal effects of remifentanil used during caesarean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013556
Enrollment
60
Registered
2017-12-11
Start date
2017-12-15
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

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 gi

Sponsors

Clinic of Gynaecology and Obstetrics Clinic of Anaesthesiology 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. 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).

Secondary

MeasureTime frame
Our second goal is to measure and compare between groups: - the amount of thiopentone needed to achieve adequate dept of anesthesia (BIS = Bispectral Index between 40 and 60) at the induction, - the end-tidal sevoflurane concentration needed to keep adequate dept of anesthesia during induction to delivery (I-D) period and during the period from the delivery until the end of the operation, - the amount of remifentanil needed to provide adequate analgesia and hemodynamic stability during the period from the delivery until the end of operation, - the intubating conditions, classified as excellent, good or poor, based on following variables: the degree of jaw relaxation and of resistance to laryngoscope, vocal cords position and movement, limb movement or cough during tube insertion and cuff inflation - the duration of whole operation, I-D period, uterine incision to delivery (U-D) period, period from the end of remifentanil administration until delivery, intraoperative blood loss, total oxytocine consumption

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