Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000758303
Ethics application status
Approved
Date submitted
27/04/2017
Date registered
23/05/2017
Date last updated
4/08/2020
Date data sharing statement initially provided
4/08/2020
Date results information initially provided
4/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of the timing and quantity of administration of crystalloid fluid on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia
Scientific title
Influence of the timing and quantity of administration of crystalloid fluid on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia: a randomized controlled study
Secondary ID [1] 289744 0
none
Universal Trial Number (UTN)
U1111-1168-3483
Trial acronym
TQCOCSSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
otherwise healthy parturients planned for cesarean section 300385 0
Condition category
Condition code
Anaesthesiology 300249 300249 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parturients were randomized into one of three groups with closed envelope method. All random numbers will conceal in sealed envelopes and assigned to a patient when entering the operating room by one anesthesiologist. Sequentially-numbered sealed opaque envelopes containing group allocation will open by the anesthesiologist responsible for fluid transfusion. First group: preload (applying fluid loading before administering the intrathecal local anesthetic) 20 ml/kg intravenous infusion Ringer's Lactate solution group (n=20), second group: preload 15 ml/kg intravenous infusion Ringer's Lactate solution group (n=20) (CONTROL GROUP) third group: coload (applying fluid loading at the after of administering the intrathecal local anesthetic) 15 ml/kg intravenous infusion Ringer's Lactate solution group (n=20). Ringer's Lactate preload solution administered during 20–25 min, prior to commencing the induction of the spinal anaesthesia. Ringer's Lactate Coload solution over 20-25 min as soon as CSF was tapped.

Patients were fasted over-night for at least 6-8 h. The patients did not receive intravenous fluid prior to entering the study.

All patients will be monitored and the basal vital functions (HR, SpO2, NIBP and StO2) will be recorded with admission into the OR.

All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach, at a level of L3-L4, with a 25 G Quincke type spinal needle and 2.0 ml hyperbaric bupivacaine.

After succesful administration of anesthesia, all patients will be placed into supine position, monitored and administered oxygene via a venturi mask after administration of spinal anesthesia until the completion of surgery in inspirated fractions (21%,) and all vital functions will be recorded (HR, SpO2, NIBP and StO2) after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively

Beside this, hemoglobin levels will be evaluated preoperatively, during surgery and postoperatively in the 30th and 60th minute, by a noninvasive continuous monitoring device.

Spinal block levels, duration of surgery, APGAR scores, vasopressor consumption will be recorded.
Intervention code [1] 295978 0
Prevention
Intervention code [2] 298009 0
Treatment: Other
Comparator / control treatment
first group: preload 20 ml/kg Ringer Lactat solution group (n=20) second group: preload 15 ml/kg Ringer Lactat solution group (n=20) (CONTROL GROUP) third group: coload 15 ml/kg Ringer Lactat solution group (n=20).
Control group
Dose comparison

Outcomes
Primary outcome [1] 300520 0
Tissue oxygenation assessed by the InSpectra tissue spectrometer (Hutchinson technology, Hutchinson, MN, USA) is the primary goal of the study.
Timepoint [1] 300520 0
StO2 will be assessed at admission to OR, after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively.
Secondary outcome [1] 330212 0
Pediatric APGAR scores which will be evaluated in the OR after delivery by a pediatrist.
Timepoint [1] 330212 0
APGAR scores in 1 minute and 5 minutes after delivery

Eligibility
Key inclusion criteria
ASA physical status I–II term parturients
undergoing elective CS under spinal anesthesia
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
ASA status; > II
Coexisting disease; metabolic, endocrine, hepatic, cardiac or renal diseases, malignancies, preeclampsia; hypertension;
Concurrent medication used; or recent use (within 48h) of any drug with anti-oxidant properties such as nebivolol, carvedilol, vitamins E and C, or acetylcysteine

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/04/2017
Date of last participant enrolment
Anticipated
1/06/2017
Actual
1/06/2017
Date of last data collection
Anticipated
2/06/2017
Actual
2/08/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8570 0
Turkey
State/province [1] 8570 0
sanliurfa

Funding & Sponsors
Funding source category [1] 295328 0
University
Name [1] 295328 0
Harran University
Country [1] 295328 0
Turkey
Primary sponsor type
Hospital
Name
Harran University School of Medicine, Research and Training Hospital
Address
Harran University School of Medicine, Research and Training Hospital.HALILIYE, SANLIURFA, TURKEY
Country
Turkey
Secondary sponsor category [1] 294151 0
None
Name [1] 294151 0
Address [1] 294151 0
Country [1] 294151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296855 0
Harran university medical faculty ethics committe
Ethics committee address [1] 296855 0
Harran University medical school yenisehir campus 63300 sanliurfa/Turkey
Ethics committee country [1] 296855 0
Date submitted for ethics approval [1] 296855 0
02/02/2015
Approval date [1] 296855 0
13/02/2015
Ethics approval number [1] 296855 0

Summary
Brief summary
Pregnant women experience an increase in sympathetic versus parasympathetic activity, together with increased susceptibility to the effects of sympathetic block – a fact that can give rise to increased vasodilatation. Prolonged severe hypotension can have harmful effects including organ ischemia, loss of consciousness, cardiovascular failure and uteroplacental hypoperfusion.

Spinal anesthesia-induced hypotension, which is pronounced in term parturients undergoing elective caesarean section, may be deleterious to both the mother and the fetus. For these reason the mother and the fetus also causes decreased oxygen delivery to both uteroplacental hypoperfusion and fetal distress. It is necessary to prevent hypotension to prevent these negative effects. The amount of fluid givenand the time of administration to prevent hypotension are important.

We aimed to investigate the effect of preload 20 ml/kg Ringer Lactat , preload 15 ml/kg Ringer Lactat and coload 15 ml/kg Ringer Lactat supplementation on maternal tissue oxygenation in elective cesarean section (CS) under spinal anesthesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66334 0
A/Prof Mahmut Alp Karahan
Address 66334 0
Harran university medical faculty
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km 63000
Sanliurfa/Turkey
Country 66334 0
Turkey
Phone 66334 0
+905327808997
Fax 66334 0
Email 66334 0
[email protected]
Contact person for public queries
Name 66335 0
A/Prof Mahmut Alp Karahan
Address 66335 0
Harran university medical faculty
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km 63000
Sanliurfa/Turkey
Country 66335 0
Turkey
Phone 66335 0
+905327808997
Fax 66335 0
Email 66335 0
[email protected]
Contact person for scientific queries
Name 66336 0
A/Prof Mahmut Alp Karahan
Address 66336 0
Harran university medical faculty
Osmanbey Campus
Sanliurfa-Mardin Karayolu Uzeri 18.Km 63000
Sanliurfa/Turkey
Country 66336 0
Turkey
Phone 66336 0
+905327808997
Fax 66336 0
Email 66336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.