Anesthesia for Laparoscopic HysterectomyEGA-LHNCT07847801
Epidural Versus General Anesthesia for Laparoscopic Hysterectomy
A study testing epidural anesthesia and General Anesthesia (GA) in people with Anesthesia for Laparoscopic Hysterectomy, run by Sabiha Başarı at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Anesthesia for Laparoscopic Hysterectomy
- What is being tested?
- epidural anesthesia and General Anesthesia (GA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2026to 22 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) ≤30 kg/m²
- Scheduled for elective laparoscopic total hysterectomy
- Willing and able to provide informed consent
Who cannot join
- Contraindication to neuraxial anesthesia
- Severe cardiopulmonary disease
- BMI >30 kg/m²
- Pre-existing neurological disorder
- Inability to cooperate with the study procedures
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya City Hospital
Kütahya, Kütahya, 43100
Sabiha Başarı, MD, +905446616686, sabihabasari0@gmail.com
sabihabasari0@gmail.com
About this study
Official title: Comparison of the Effects of Epidural Anesthesia and General Anesthesia on Postoperative Respiratory Function and Pain in Laparoscopic Hysterectomy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anesthesia for Laparoscopic Hysterectomy
- Being tested
- epidural anesthesia, General Anesthesia (GA)
- Keywords
- Epidural Anesthesia, General Anesthesia, Laparoscopic Hysterectomy, Postoperative Respiratory Function, Peak Expiratory Flow Rate, Postoperative Pain, Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaProcedure or surgery
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 (GA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Anesthesia | Experimental | 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. Receives: Procedure: epidural anesthesia |
| General Anesthesia | Active comparator | 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. Receives: Procedure: General Anesthesia (GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative baseline and 2, 6, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start22 Oct 2026 (estimated)
- Primary completion22 Oct 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the epidural anesthesia group or the general anesthesia group. Each participant will receive only the intervention assigned to their group.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sabiha Başarı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabiha Başarı, Kutahya City Hospital
- Investigators
- Sabiha Başarı, MD, Principal investigator, Kutahya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847801
- Sponsor's protocol ID
- KSH-ARKHD-001
- Acronym
- EGA-LH
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Epidural Anesthesia and General Anesthesia on Postoperative Respiratory Function and Pain in Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07847801
- Acronym / sponsor ID
- EGA-LH / KSH-ARKHD-001
- Conditions
- Anesthesia for Laparoscopic Hysterectomy
- Keywords
- Epidural Anesthesia, General Anesthesia, Laparoscopic Hysterectomy, Postoperative Respiratory Function, Peak Expiratory Flow Rate, Postoperative Pain, Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sabiha BaşarıUniversity, hospital or other
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the epidural anesthesia group or the general anesthesia group. Each participant will receive only the intervention assigned to their group.
| Arm | Type | Receives |
|---|---|---|
| Epidural Anesthesia | Experimental | Procedure: epidural anesthesiaParticipants 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. |
| General Anesthesia | Active comparator | Procedure: General Anesthesia (GA)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) ≤30 kg/m²
- Scheduled for elective laparoscopic total hysterectomy
- Willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Contraindication to neuraxial anesthesia
- Severe cardiopulmonary disease
- BMI >30 kg/m²
- Pre-existing neurological disorder
- Inability to cooperate with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural anesthesiapidural 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. | Procedure or surgery | Epidural Anesthesia |
| General Anesthesia (GA)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. | Procedure or surgery | General Anesthesia |
Primary outcome
Change in Peak Expiratory Flow Rate (PEFR)
Time frame: Preoperative baseline and 2, 6, and 24 hours after surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Anesthesia for Laparoscopic Hysterectomy
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Effect of Trendelenburg Position on Patient State Index
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Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy
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Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy
Sevoflurane, Lidocaine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabiha Başarı, MD principal investigator
Kutahya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural anesthesia and General Anesthesia (GA) in people with Anesthesia for Laparoscopic Hysterectomy, run by Sabiha Başarı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabiha Başarı, MD (+905446616686, sabihabasari0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Expiratory Flow Rate (PEFR) (time frame: Preoperative baseline and 2, 6, and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.