Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002051224
Ethics application status
Approved
Date submitted
25/11/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The assessment of optimal anesthesia technique for cesarian section and its clinical effects on mother and newborns.
Scientific title
The assessment of optimal anesthesia technique for cesarian section and its clinical effects on mother and newborns.
Secondary ID [1] 296705 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal anesthesia 310555 0
epidural anesthesia 310556 0
general anesthesia 310557 0
Condition category
Condition code
Anaesthesiology 309266 309266 0 0
Other anaesthesiology
Reproductive Health and Childbirth 309267 309267 0 0
Breast feeding
Oral and Gastrointestinal 309268 309268 0 0
Normal oral and gastrointestinal development and function
Reproductive Health and Childbirth 309269 309269 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seventy-five ASA II parturients who did not have endocrine, cardiopulmonary, renal, hepatic or neuromuscular diseases, and undergo cesarean section for their first delivery, and in their 38th week of the pregnancy, without preeclampsia or fetal problems (fetal abnormalities, growth retardation, umbilical artery anomalies, malposition) were included. Patients were randomly divided into three groups (n=25): general anesthesia, epidural anesthesia and spinal anesthesia. The randomization was performed using sequentially numbered, opaque sealed envelopes.
In General anesthesia group, patients received 5 mg/kg thiopental sodium and 0.6 mg/kg rocuronium bromide intravenous for induction of anesthesia. After the patients were intubated, anesthesia was maintained with 30% O2, 70% N2O and 1-2% sevoflurane. Mechanical ventilation was performed by setting the tidal volume at 6-8 mL/kg and the respiratory rate at 8-10/minute. Patients were ventilated with 100% O2 during the period between placement of bladder retractor and cord clamping after delivery. Neuromuscular block was antagonized with 0.03-0.07 mg/kg neostigmine and 0.02 mg/kg atropine sulfate intravenous. Patients in Epidural anesthesia group were administered 16 mL of 0.5% bupivacaine + 3 mg morphine in lateral position through the L4-L5 intervertebral space using an 18 G Touhy needle by the loss of resistance technique. An epidural catheter was left 5 cm in the epidural space.
In Spinal anesthesia group, 3 mL of 0.5% bupivacaine with 200 µg morphine through the L4-L5 intervertebral space by a 25 G spinal needle (Quincke) in lateral decubitus position. In Group Epidural anesthesia and Spinal anesthesia, surgery was started by the time the sensory block reached the T4 dermatome. The level of sensory block was assessed by the ‘Pinprick’ test. Motor block was assessed using the Bromage Scale.
Mean arterial pressure, heart rate and SpO2 values were recorded before and after anesthesia induction, and at the 1st, 5th, 10th, 20th, and 40th minutes of surgical incision. Decrease of heart rate below 30% of the basal values was considered as bradycardia and 0.5 mg atropine was administered. When mean arterial pressure showed a decrease of more than 30%, it was regarded as hypotension and ephedrine 10 mg was injected intravenous as a bolus dose.
Skin-uterine incision time, uterine incision-delivery time, perioperative bleeding, crystalloid requirement, total amount of intravenous ephedrine requirement were recorded. The time of defecation and mobilization, discharge of mother and the time to first breastfeeding from delivery of the newborn were also recorded.
The time when the postoperative pain score (according to Numeric Rating Scale), 0= no pain, 10= extreme pain) increased by 3 or higher was recorded as the first analgesia requirement time. General anesthesia and spinal anesthesia groups were administered 1 mg/kg meperidine intravenous every 6 hours and 1 g paracetamol intravenous every 8 hours. The epidural anesthesia group received a mixture of 3 mg morphine and 15 mg bupivacaine in a volume of 9 cc through the epidural catheter.
A pediatrician examined the newborns. The newborns were monitored and their SpO2 and APGAR scores were recorded at the 1st, 5th and 10th minutes. Blood gas analysis obtained from umblical ven was examined. In the postoperative period, time to first breastfeeding of the newborn, phototherapy requirement, level of bilirubin, weight loss of the newborn at the 24th and 48th hours and the need at birth for free O2, positive-pressure ventilation, chest compressions, intubation and intensive care admission were also recorded.
Intervention code [1] 313017 0
Early detection / Screening
Comparator / control treatment
General anesthesia group is control group.
Control group
Active

Outcomes
Primary outcome [1] 308244 0
The study was to evaluate the effect of the anesthesia technique on the APGAR score, The APGAR score is calculated by the pediatrician who has attended in labor at the time points 1, 5 and 10 minutes after birth as described in the literature.
Timepoint [1] 308244 0
1st, 5th and 10th minute from birth
Primary outcome [2] 308245 0
Blood gas analysis obtained from umblical veIn was examined at birth for becoming fetal acidosis
Timepoint [2] 308245 0
Blood gas analysis obtained from umblical ven was examined at birth in the operating room
Primary outcome [3] 308263 0
The need for respiratory support in newborns. The need for respiratory support is assess as following; the need at birth for free O2, positive-pressure ventilation (PPV), chest compressions, intubation and intensive care admission were obtained from the hospital records.
Timepoint [3] 308263 0
24 hours after surgery
Secondary outcome [1] 354364 0
the time to return of the bowel function meaning the first defecation time of the mother was obtained from the hospital records.
Timepoint [1] 354364 0
48 hours after surgery.
Secondary outcome [2] 354475 0
Time to first breastfeeding: is the time from labor to first breastfeeding of the newborn. first breastfeeding was obtained from the hospital records.
Timepoint [2] 354475 0
the time from labor to first breastfeeding of the newborn. first breastfeeding was obtained from the hospital records.
Secondary outcome [3] 354953 0
Crystalloid requirement: Total amount of intravenous crystalloid given to the mother during the surgery. The requirement of crystalloid was recorded by anesthesiologist.
Timepoint [3] 354953 0
during the surgery
Secondary outcome [4] 354954 0
phototherapy requirement: decision was given by the pediatrician according to the bilirubin levels of the newborn, bilirubin levels were recorded from hospital records.
Timepoint [4] 354954 0
first 48 hours after birth
Secondary outcome [5] 354955 0
level of bilirubin: biochemical test results for levels of bilirubin from blood sample of patient's.
Timepoint [5] 354955 0
first 48 hours after birth
Secondary outcome [6] 354956 0
ephedrine requirement: when the mean arterial pressure showed a decrease of more than 30%, it was regarded as hypotension and ephedrine 10 mg was injected iv as a bolus dose., total dose of ephedrine requirement during the surgery.The need for ephedrine was recorded by anesthesiologist.
Timepoint [6] 354956 0
during the surgery
Secondary outcome [7] 355138 0
hospital discharge:time to discharge of mother obtained from hospital records
Timepoint [7] 355138 0
time to discharge of mother obtained from hospital records
Secondary outcome [8] 355139 0
weight loss of the newborns
Timepoint [8] 355139 0
weight loss of the newborn in the first 48 hours after delivery, the information is obtained from the hospital records

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) II parturients
first delivery
38th week of the pregnancy,
Minimum age
No limit
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
endocrine, cardiopulmonary, renal, hepatic or neuromuscular diseases
preeclampsia or fetal problems (fetal abnormalities, growth retardation, umbilical artery anomalies, malposition)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2012
Date of last participant enrolment
Anticipated
Actual
15/11/2012
Date of last data collection
Anticipated
Actual
19/11/2012
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 21068 0
Turkey
State/province [1] 21068 0
istanbul

Funding & Sponsors
Funding source category [1] 301286 0
Hospital
Name [1] 301286 0
Marmara Universty Pendik Training and Education Hospital
Country [1] 301286 0
Turkey
Primary sponsor type
Individual
Name
meliha Orhon Ergun
Address
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country
Turkey
Secondary sponsor category [1] 300934 0
Individual
Name [1] 300934 0
zeynep Eti
Address [1] 300934 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [1] 300934 0
Turkey
Secondary sponsor category [2] 300935 0
Individual
Name [2] 300935 0
Kemal Tolga Saracoglu
Address [2] 300935 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [2] 300935 0
Turkey
Secondary sponsor category [3] 300936 0
Individual
Name [3] 300936 0
Asli Memisoglu
Address [3] 300936 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [3] 300936 0
Turkey
Secondary sponsor category [4] 300937 0
Individual
Name [4] 300937 0
Elif Malcok
Address [4] 300937 0
Marmara Universty Pendik Training and Education Hospital
Fevzi cakmak neighborhood, Muhsin yazicioglu street , 34899 Pendik / istanbul
Country [4] 300937 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302028 0
Kartal Training and Education Hospital
Ethics committee address [1] 302028 0
Ethics committee country [1] 302028 0
Turkey
Date submitted for ethics approval [1] 302028 0
10/04/2012
Approval date [1] 302028 0
11/05/2012
Ethics approval number [1] 302028 0
B104ISM4340029-1009-90

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88890 0
Dr Meliha Orhon Ergun
Address 88890 0
Marmara University Pendik Training and Education Hospital
Fevzi Cakmak neighborhood, Mohsin Yazicioglu street, 34899 Pendik / istanbul
Country 88890 0
Turkey
Phone 88890 0
+905413402001
Fax 88890 0
Email 88890 0
[email protected]
Contact person for public queries
Name 88891 0
Meliha Orhon Ergun
Address 88891 0
Marmara University Pendik Training and Education Hospital
Fevzi Cakmak neighborhood, Mohsin Yazicioglu street, 34899 Pendik / istanbul
Country 88891 0
Turkey
Phone 88891 0
+905413402001
Fax 88891 0
Email 88891 0
[email protected]
Contact person for scientific queries
Name 88892 0
Kemal Tolga Saracoglu
Address 88892 0
Marmara University Pendik Training and Education Hospital
Fevzi Cakmak neighborhood, Mohsin Yazicioglu street, 34899 Pendik / istanbul
Country 88892 0
Turkey
Phone 88892 0
+905385478620
Fax 88892 0
Email 88892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.