Pregnancy, Neonatal Hearing Function
Conditions
Keywords
Cesarean section, Combined spinal-epidural anesthesia, General anesthesia, Neonatal hearing, Transient evoked otoacoustic emission
Brief summary
This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.
Detailed description
This is a single-center, prospective, single-blind, parallel-group randomized controlled trial. A total of 144 eligible parturients undergoing cesarean section will be enrolled and randomly allocated in a 1:1 ratio to the combined spinal-epidural anesthesia (CSEA) group or general anesthesia (GA) group. An independent statistician will generate the randomization sequence using a computerized random number table. Allocation concealment will be maintained using sealed, opaque, sequentially numbered envelopes, which will be opened by an independent coordinator after enrollment. Participants will not be informed of their assigned anesthesia group. Anesthesia providers and surgical teams will be aware of group assignment. All outcome assessors, including personnel recording hemodynamic data, assessing Apgar scores, performing TEOAE hearing screening, and collecting postoperative VAS pain scores and adverse-event data, will remain blinded to group allocation to reduce assessment bias. The investigators will compare maternal intraoperative hemodynamic changes and record the interval from anesthesia administration to neonatal delivery. Neonatal Apgar scores will be recorded at 1 and 5 minutes. Maternal postoperative Visual Analogue Scale (VAS) pain scores will be collected at 1, 6, 12, 24, and 48 hours after surgery. Neonatal hearing outcomes will include initial and repeat transient evoked otoacoustic emission (TEOAE) screening results. Infants who fail repeat screening will undergo further hearing assessment at 3-6 months of age to identify hearing loss.
Interventions
PROCEDURECombined spinal-epidural anesthesia
Combined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol
PROCEDUREGeneral Anesthesia (GA)
General anesthesia performed for cesarean delivery
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are blinded to anesthesia allocation. Anesthesiologists and surgical team are unblinded. All outcome assessors including audiologists, staff collecting hemodynamic data, Apgar scores and VAS pain scores remain blinded to group assignment to reduce bias.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
(a) Singleton pregnancy with gestational age 37-42 weeks; (b) Maternal age 18-35 years; (c) American Society of Anesthesiologists (ASA) physical status II; (d) Scheduled for elective cesarean delivery based on clinical indications; (e) Written informed consent obtained from the parturient and her family.
Exclusion criteria
1. Refusal to participate; 2. Contraindications to neuraxial anesthesia; 3. Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities; 4. History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications; 5. Neonatal hyperbilirubinemia or birth weight \<2,500 g; 6. Anticipated intraoperative conditions that would prevent completion of the study per the prespecified protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE) | Within 72 hours after delivery | The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal intraoperative hemodynamic changes | during surgery | Changes in maternal blood pressure and heart rate during cesarean section. |
| Neonatal Apgar scores | 1 minute and 5 minutes after birth | Apgar scores will be assessed at 1 and 5 minutes after birth. The Apgar score evaluates five components: Appearance, Pulse, Grimace, Activity, and Respiration. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition and a better outcome. |
| Postoperative maternal VAS pain score | 1 hour, 6 hours, 12 hours, 24 hours and 48 hours after surgery | Postoperative maternal pain intensity will be assessed using the Visual Analog Scale (VAS) at 1, 6, 12, 24, and 48 hours after cesarean delivery. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome. |
Countries
China
Contacts
CONTACTBaiping Mao, PhD
Outcome results
None listed