- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07569783
tDCS for Reducing the Incidence of OEI After Cesarean Section
Study on the Preventive and Therapeutic Effects and Mechanism of Transcranial Direct Current Stimulation on Morphine-Induced Itching After Cesarean Section: A Randomized Clinical Controlled Trial
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: chao chao zhong, Doctor of Medicine
- Telefonnummer: 15152460489
- E-mail: zhong249767626@163.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
① Age 18-40 years, gestational age 37-41 weeks, singleton full-term pregnancy;
Planned elective or emergency cesarean section, using epidural anesthesia (0.1~0.2 mg/kg of morphine administered intrathecally during surgery);
American Society of Anesthesiologists (ASA) classification I-III;
Conscious and able to cooperate to complete scale assessments, serum sample collection, and postoperative follow-up;
- Voluntarily participate in the study and sign the informed consent form.
Exclusion Criteria:
① Presence of contraindications for tDCS (such as skull defects, intracranial metal implants, history of epilepsy, coagulation disorders);
Allergy to opioids or a history of severe OEI;
Presence of skin diseases (such as eczema, urticaria), liver diseases (cholestasis), mental disorders, or cognitive impairments;
Coexisting pregnancy complications (preeclampsia, gestational diabetes, autoimmune diseases);
⑤ Use of medications within the past week that may affect itch assessment, such as antihistamines, 5-HT3 receptor antagonists, or anti-inflammatory drugs.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Sham-komparator: control group (sham stimulation group)
|
Patients in the transcranial direct current stimulation (tDCS) group had the anode of the tDCS device placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid.
tDCS was administered on the day of surgery (starting within 5 minutes after fetal delivery and terminating after the surgery upon transfer to the PACU).
The current intensity was 1.5 mA.
Patients in the sham stimulation group had the anode placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid, with a current of 1.5 mA applied only during the initial 30 seconds after stimulation begins, after which the current was reduced to 0 mA.
All other procedures (electrode placement, stimulation duration, intervention frequency) were identical to the experimental group.
|
|
Eksperimentel: Case group (tDCS group)
|
Patients in the transcranial direct current stimulation (tDCS) group had the anode of the tDCS device placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid.
tDCS was administered on the day of surgery (starting within 5 minutes after fetal delivery and terminating after the surgery upon transfer to the PACU).
The current intensity was 1.5 mA.
Patients in the sham stimulation group had the anode placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid, with a current of 1.5 mA applied only during the initial 30 seconds after stimulation begins, after which the current was reduced to 0 mA.
All other procedures (electrode placement, stimulation duration, intervention frequency) were identical to the experimental group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
Tidsramme: 24 hours after surgery
|
24 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of itching at 12 and 48 hours postoperatively; VAS scores for itching at each time point; duration of itching and time of peak appearance
Tidsramme: 12 hours post-operation and 48 hours post-operation
|
12 hours post-operation and 48 hours post-operation
|
|
Number of times the analgesic pump was pressed and the doses of additional morphine within 48 hours postoperatively; VAS pain scores at 12, 24, and 48 hours postoperatively
Tidsramme: 12 hours, 24 hours, and 48 hours after surgery
|
12 hours, 24 hours, and 48 hours after surgery
|
|
Maternal adverse reactions (nausea and vomiting, drowsiness, dizziness, ear pain, skin erythema) incidence; neonatal 1-minute and 5-minute Apgar scores, birth weight, complications within 72 hours (jaundice, shortness of breath, feeding difficulties)
Tidsramme: Within 72 hours after surgery
|
Within 72 hours after surgery
|
|
Preoperative and postoperative 24h serum histamine, trypsin-like enzyme, TNF-α, IL-6, β-endorphin, and gastrin-releasing peptide precursor (ProGRP) levels
Tidsramme: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-K102-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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