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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013556
• Date of registration: 11/12/2017
• Prospective Registration: Yes
• Primary sponsor: Clinic of Gynaecology and Obstetrics Clinic of Anaesthesiology University Clinical Center Nis
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 15/12/2017
• Target sample size: 60
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00013556
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active//No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
• Phase: 4

Countries of recruitment

Serbia

Contacts

• Name: Marija Kutlesic
• Affiliation: Clinic of Gynaecology and Obstetrics University Clinical Centre Nis

• Name: Marija Kutlesic
• Affiliation: Clinic of Gynaecology and Obstetrics University Clinical Centre Nis

Key inclusion & exclusion 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 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.

Age minimum: 19 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Stress response to anesthesia and surgery during elective caesarean section

Intervention(s)

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 given remifentanil until the delivery of the baby

Primary Outcome(s)

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 Outcome(s)

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

Source(s) of Monetary Support

Faculty of medicine Nis University of Nis

Ethics review

Status: Approved
Approval date: 09/03/2015
Contact:

Ethics Committee of Medical faculty University of Nis [Ethics Commitee of Faculty of medicine University of Nis]

Results

• Date Completed: 28/01/2018
• URL: http://drks.de/search/en/trial/DRKS00013556#studyResults