Skip to content

Influence of the timing and quantity of administration of crystalloid fluid on tissue oxygenation in parturients undergoing cesarean section under spinal anesthesia

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000758303
Acronym
TQCOCSSA
Enrollment
60
Registered
2017-05-23
Start date
2017-04-17
Completion date
2017-06-01
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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'

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.

Sponsors

Harran University School of Medicine, Research and Training Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

ASA physical status I–II term parturients undergoing elective CS under spinal anesthesia

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026