Predictive Value of ONSD and NIRS for PDPH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorOrdu University
About this trial
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn.
In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-40 years,
American Society of Anesthesiologists (ASA) physical status classification of II or III,
Beyond 37 weeks of gestation,
Elective cesarean delivery,
Disqualifiers
Patients undergoing emergency cesarean delivery
Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)
Presence of preoperative anemia (Hemoglobin < 11 g/dL),
History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,
Trial population
Pregnant women aged 18-40 years who are scheduled to undergo elective cesarean section under spinal anesthesia at the tertiary care hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
44 Participants
are grouped into 2 trial groupsGroup A: PDPH Group
Group B: Non-PDPH Group
Trial outcomes
Primary outcomes
1
Perioperative Optic Nerve Sheath Diameter (ONSD) Changes
Optic nerve sheath diameter (ONSD) measurements will be performed in patients in the supine position using a 7.5 megahertz linear ultrasound probe by an anesthesiologist with at least three years of experience and over one hundred procedure experiences. Imaging will be obtained in a plane perpendicular to the optic nerve axis through a thin layer of gel applied over closed eyelids. Measurements will be performed 3 mm behind the optic papilla, based on the outer hypoechoic margins. At the determined time points during the perioperative period, the arithmetic mean of a total of four measurements obtained in both transverse and sagittal planes for each eye will be recorded in the data tracking form as the final ONSD value. Optic nerve sheath diameter (ONSD) measurements (in mm) assessed via transorbital ultrasonography to evaluate its predictive value for the development of post-dural puncture headache (PDPH).
Time frame
Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperativelySecondary outcomes
1
Cerebral Oxygenation (rSO2) Changes
The incidence of cerebral desaturation following spinal anesthesia will be monitored. Cerebral oxygen saturation (R-NIRS and L-NIRS) will be continuously monitored using NIRS. A decrease in any of the NIRS values of 20% or more relative to baseline within the first 20 minutes will be defined as "cerebral desaturation." In the event of cerebral desaturation, oxygen support will first be optimized; after ruling out potential mechanical factors and bleeding, a norepinephrine infusion will be initiated to optimize cerebral perfusion pressure. The total amount of norepinephrine consumption will be recorded in the data tracking form. Cerebral Oxygenation values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.
Time frame
intraoperative period2
The Incidence of Post-spinal Hypotension
The incidence of post-spinal hypotension will be recorded. Post-spinal hypotension will be defined as a decrease in MAP of 20% or more relative to baseline, or an absolute mean arterial pressure (MAP) value falling below 65 mmHg within the first 20 minutes following spinal anesthesia. In patients who develop hypotension, normotension will be targeted using hydration and administration of ephedrine/norepinephrine, and the total amounts of vasopressors (ephedrine and norepinephrine) administered will be recorded in the data tracking form. MAP values will be recorded in the data form every 3 minutes for the first 15 minutes following spinal anesthesia, and every 5 minutes during the remainder of the intraoperative period.
Time frame
intraoperative periodSponsors and contacts
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Source ClinicalTrials.gov