The main objective of this study is to compare changes in maternal temperature and oxygen saturation in patients receiving remifentanil, administered intravenous patient-controlled, with those of epidural analgesia.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Maternal temperature
* Maternal saturation
Secondary outcome
* To compare the incidences of other known side effects, in particular nausea,
pruritus, sedation and hypotension.
* Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and
requirement for naloxone.
Background summary
Epidural analgesia is considered to be the best form of pain relief during
labor. However its use has been associated with an increase of maternal
temperature. This can lead to unnecessary administration of antibiotics during
labor and observation and treatment for sepsis of neonates.
A relatively new option for obstetric analgesia is remifentanil PCA. Possible
adverse effects of remifentanil resemble those of other opioids and include
hypotension and respiratory depression.
Hypothesis:
1. Epidural analgesia leads to a higher frequency of maternal fever as compared
to patients receiving remifentanil PCA or no analgesia.
2. Maternal saturation scores are lower in parturients receiving remifentanil
PCA compared to patients receiving epidural analgesia or no analgesia.
Study objective
The main objective of this study is to compare changes in maternal temperature
and oxygen saturation in patients receiving remifentanil, administered
intravenous patient-controlled, with those of epidural analgesia.
Study design
This study will be a prospective randomized controlled trial and will evaluate
differences in maternal saturation and temperature in parturients receiving
either remifentanil PCA or epidural analgesia.
Intervention
Remifentanil group: 40microgram boluses, lockout time 2 min. Maximum dose
limit is 1200 microgram/hour.
Epidural group: ropivacaine plus sufentanil.
Loading dose 25 mg (12.5 ml ropivacaine 0.2%), followed by continuous infusion
of ropivacaine 0.1%/sufentanil 0.5 microgram/ml.
Infusion rate 10 ml/hour.
In case of inadequate analgesia, additional boluses of the epidural solution
will be given.
Study burden and risks
Pulse and saturation will be monitored continuously by means of a Nonin WristOx
pulsoximeter.
Maternal bloodpressure, temperature and respiratory rate will be recorded
hourly.
In patients receiving epidural analgesia or remifentanil PCA, measurements of
bloodpressure and respiratory rate will be recorded every 5 minutes for the
fist 30 minutes, and every hour afterwards.
Painscores will be assessed using a visual analogue scale every hour. After
delivery patients will be asked to give an overall satisfaction score
Fetal heart rate and uterine activity will be monitored continuously by
external monitoring and if necessary by invasive monitoring.
In patients receiving epidural analgesia, motor block of the lower limbs will
be assessed.
Adverse effects of analgesics used in this study include hypotension, nausea
and rarely respiratory depression. For savety reasons, there will be a observer
in the delivery suite all times providing continuous monitoring.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
* Age *18 years
* Between 37-42 weeks of gestation
* Singleton pregnancy
* ASA physical status I or II
Exclusion criteria
* Prior administration of regional of opioid analgesia (during this delivery).
* Morbid obesity (BMI * 40 kg/m2)
* Drug allergy: history of hypersensitivity to opioid or local anesthetic substances
* High risk pregnancy: including severe asthma (daily use of medication), insulin dependent diabetes, severe pre-eclampsia (proteinuria * 5 grams)
* Use of antibiotics during delivery
* Initial maternal SpO2 of less than 98%
* Initial maternal temperature of 38°C or higher.
* Cervical dilation of > 7 cm
* Ruptured membranes for more than 24 hours at time of inclusion
* Contraindication for epidural analgesia
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2008-002792-28-NL |
CCMO | NL23193.058.08 |