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Not Yet Recruiting NCT07916051

Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section

Conditions: Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section, Enhanced Recovery After Surgery

Sex: Female
Ages: 18 Years – 99 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 384
Sponsor: Anhui Provincial Hospital

Summary

This study is a prospective randomized controlled trial aimed at evaluating whether the combination of esketamine and transcutaneous electrical acupoint stimulation (TEAS) can improve the quality of postoperative recovery in women undergoing elective cesarean section. First-time mothers scheduled for surgery will be randomly assigned to one of four groups: a control group (standard care), a TEAS group, an esketamine group, or a combined group (TEAS plus esketamine). TEAS will be applied to specific acupoints before delivery. Esketamine (0.15 mg/kg) will be administered intravenously immediately after the umbilical cord is clamped to minimize fetal exposure. The primary outcome is the overall quality of recovery, assessed using the ObsQoR-11 scale during the first three days after surgery. We will also evaluate pain levels, sleep quality, anxiety and depression, early recovery milestones, inflammatory responses, adverse reactions, and newborn safety. The results may provide an effective multi-modal strategy to enhance recovery for mothers after a cesarean delivery.

Eligibility Criteria

Inclusion Criteria: \- Age ≥ 18 years. (No upper age limit). Primiparous women. American Society of Anesthesiologists (ASA) physical status I or II. Gestational age between 37 and 42 weeks. Scheduled for elective cesarean section under epidural anesthesia. Exclusion Criteria: \- History of allergy or contraindication to esketamine. Contraindications to neuraxial anesthesia (e.g., coagulopathy). Severe pregnancy complications (e.g., severe fetal distress, umbilical cord prolapse, placenta previa with massive hemorrhage, placental abruption). Severe dysfunction of vital organs. Skin breakdown or infection at the selected acupoint sites.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07916051). StuddyBuddy aggregates publicly available trial information.