An interventional study of epidural anesthesia and General Anesthesia (GA) in Anesthesia for Laparoscopic Hysterectomy, sponsored by Sabiha Başarı. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Sabiha Başarı · Not applicable, Interventional, and Other
This randomized controlled study will compare epidural anesthesia with general anesthesia in women undergoing elective laparoscopic hysterectomy. A total of 70 participants will be randomly assigned to receive either epidural anesthesia or general anesthesia.
The main aim of the study is to determine whether the type of anesthesia affects respiratory function after surgery. Respiratory function will primarily be assessed using peak expiratory flow rate (PEFR) before surgery and at 2, 6, and 24 hours after surgery.
The study will also compare postoperative pain, opioid consumption, respiratory and hemodynamic parameters, recovery, mobilization, and other perioperative outcomes between the two groups.
The researchers aim to determine whether epidural anesthesia may provide an alternative anesthetic approach for selected patients undergoing laparoscopic hysterectomy while maintaining spontaneous breathing.
This is a prospective, single-center, randomized, controlled, parallel-group study involving 70 adult women scheduled for elective laparoscopic total hysterectomy.
Participants will be randomly allocated in a 1:1 ratio to an epidural anesthesia group or a general anesthesia group. In the epidural anesthesia group, anesthesia will be provided through a lumbar epidural catheter, with spontaneous ventilation maintained. Sedation will be provided as required. In the general anesthesia group, anesthesia will be induced intravenously, followed by endotracheal intubation and controlled mechanical ventilation.
Respiratory function will be evaluated using peak expiratory flow rate (PEFR) before surgery and at 2, 6, and 24 hours after surgery. Postoperative pain scores, opioid consumption, respiratory and hemodynamic parameters, recovery characteristics, mobilization, and perioperative adverse events will also be evaluated.
Participants in the epidural anesthesia group may be converted to general anesthesia if the epidural block is inadequate, the participant cannot tolerate the procedure, or conversion is considered clinically necessary.
Exclusion Criteria:
Participants assigned to this arm will receive epidural anesthesia via a lumbar epidural catheter. An initial dose of 10 mL of 0.5% bupivacaine with 50 mcg fentanyl will be administered, followed by incremental doses of 2-3 mL of 0.5% bupivacaine every 5 minutes as required to achieve a T4 sensory block, up to approximately 20 mL. Spontaneous ventilation will be maintained. Dexmedetomidine will be administered at 0.2 mcg/kg/h for sedation. Conversion to general anesthesia will be performed if the epidural block is inadequate, the participant cannot tolerate the procedure, or conversion is clinically required.
Procedure: epidural anesthesia
Participants assigned to this arm will receive standard general anesthesia. Anesthesia will be induced with propofol 2-2.5 mg/kg, fentanyl 1-2 mcg/kg, and rocuronium 0.6 mg/kg, followed by endotracheal intubation. Anesthesia will be maintained with sevoflurane and controlled mechanical ventilation, with end-tidal carbon dioxide maintained between 35 and 40 mmHg.
Procedure: General Anesthesia (GA)
pidural anesthesia will be administered via a lumbar epidural catheter using 0.5% bupivacaine and fentanyl. Incremental epidural doses will be administered to achieve an adequate sensory block. Spontaneous ventilation will be maintained, and dexmedetomidine will be used for sedation.
General anesthesia will be induced with intravenous propofol, fentanyl, and rocuronium, followed by endotracheal intubation. Anesthesia will be maintained with sevoflurane and controlled mechanical ventilation.
Change in Peak Expiratory Flow Rate (PEFR)
Peak expiratory flow rate (PEFR), measured in liters per minute (L/min), will be assessed before surgery and at 2, 6, and 24 hours after surgery. The change in PEFR from the preoperative baseline will be compared between the epidural anesthesia and general anesthesia groups
Time frame: Preoperative baseline and 2, 6, and 24 hours after surgery
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the published article may be shared upon reasonable request to the corresponding author.
Supporting information: Study protocol, Sap
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