Anesthesia Depth MonitoringNCT07023263
Target-Controlled Infusion (TCI) Effectiveness in Hysteroscopy
An observational study of Anesthesia Depth Monitoring and Analgesia Assessment, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, observational study aims to evaluate the perioperative anesthetic efficacy of different Target-Controlled Infusion (TCI) models-specifically Minto, Schnider, and Eleveld pharmacokinetic models-in patients undergoing hysteroscopy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia Depth Monitoring, Analgesia Assessment, Perioperative Safety and Recovery
- What is being tested?
- Schnider+ Mİnto and Eleveld
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 30 Aug 2025
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include female patients aged 18 to 65 years who are scheduled to undergo elective hysteroscopic surgery under general anesthesia. Eligible participants must be classified as ASA Physical Status I-II, with no significant comorbidities. All patients will provide written informed consent prior to enrollment. Patients with a history of significant cardiac, pulmonary, or neurological disease, known allergies to propofol or remifentanil, pregnancy or breastfeeding status, body mass index (BMI) >35, or substance use disorder will be excluded. A total of 90 patients will be randomized into two groups (45 patients each) to receive anesthesia with different TCI models. The study population is limited to a single academic tertiary care center (Gazi University Faculty of Medicine, Department of Anesthesiology and Reanimation).
Who may be able to join
- Female, aged 18-65
- ASA I-II
- Scheduled for hysteroscopy under general anesthesia
- Signed informed consent
Who cannot join
- Allergy to study drugs
- Significant cardiac, pulmonary, neurological disease
- Pregnancy or breastfeeding
- BMI >35
- Substance use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perioperative Anesthesia Effectiveness in Hysteroscopy Cases Administered With Target-Controlled Infusion (TCI)
This prospective, randomized, observational study aims to evaluate the perioperative anesthetic efficacy of different Target-Controlled Infusion (TCI) models-specifically Minto, Schnider, and Eleveld pharmacokinetic models-in patients undergoing hysteroscopy under general anesthesia. 90 female patients will be randomized into two groups, each receiving different TCI model combinations for propofol and remifentanil. Primary outcomes include intraoperative consciousness (BIS/SEF), analgesia (ANI), tissue oxygenation (NIRS), and recovery parameters. The study seeks to identify model-specific benefits regarding patient and surgeon satisfaction, recovery time, and complication rates.
Read the detailed description
This study aims to evaluate the perioperative anesthetic efficacy of target-controlled infusion (TCI) in hysteroscopy cases. The study will be conducted in the Gynecology and Obstetrics Operating Room located on the 9th floor of Gazi University Hospital between April 2025 and July 2025.
The study will include women aged 18-65 years who will undergo hysteroscopy and meet the criteria of ASA I-II classification, with no significant comorbidities and a BMI < 35. The study is planned in two groups, with each group consisting of 45 patients, totaling 90 participants.
In the first group, TCI protocols based on the Schnider and Minto models will be applied. The initial target concentrations for propofol and remifentanil infusion will be set at 5 µg/mL and 4 ng/mL, respectively. In the second group, the Eleveld model will be used. The propofol dose will be adjusted according to the patient's age using the Eleveld algorithm, and the remifentanil effect-site concentration will be maintained at 3 ng/mL.
Participants will be informed about the study, and those eligible and willing to participate will provide signed informed consent. Upon being brought to the operating room, intravenous access will be checked and established if not already in place. Non-invasive blood pressure, heart rate, and oxygen saturation will be monitored in accordance with ASA standards.
Following this, Masimo Root device with SedLine, NIRS, and ANI sensors will be attached to the appropriate sites on the patients, ensuring data flow. These sensors will continuously monitor the patient's level of consciousness, tissue oxygenation, and pain response.
The Braun Space Plus Perfusor will be utilized as the TCI device. Patient-specific data, including age, height, weight, and gender, will be entered, and the effect-site concentrations for propofol and remifentanil will be set according to the respective TCI model being applied. Once all settings are confirmed and the device is operational, TCI infusion will be initiated.
After achieving loss of consciousness, a Laryngeal Mask Airway (LMA) of appropriate size will be inserted, and the patient will be connected to a ventilator. During the procedure, TCI infusion rates will be adjusted to maintain a SedLine value between 25-50 for propofol and an ANI range of 50-70 for remifentanil, ensuring hemodynamic stability.
Throughout the operation, hemodynamic data, SedLine, NIRS, and ANI values will be continuously monitored and recorded at specified intervals in the Case Report Form (CRF). The concentrations and total amounts of propofol and remifentanil administered will also be regularly monitored and documented.
Upon completion of the surgical procedure and initiation of hemostasis, TCI infusion will be terminated. Patients with increased SedLine values will have their LMAs removed when appropriate, and those who are alert and without respiratory distress will be transferred to the recovery room. In this phase, hemodynamic parameters, VAS pain scores, Aldrete scores, and nausea/vomiting status will be assessed and recorded. Patients achieving an Aldrete score of 10, who are hemodynamically stable and without complications, will be transferred to the service ward.
Additionally, patient and surgeon satisfaction will be evaluated and recorded in the CRF. All data will be analyzed using SPSS 27.0 software. Intraoperative drug consumption, time to loss of consciousness, recovery duration, and complication rates will be analyzed using ANOVA. Correlation analyses will assess the relationships between drug consumption and recovery times.
Confidentiality will be strictly maintained throughout the study. Data will be accessible only to the research team and will be coded to ensure participant anonymity.
- Conditions
- Anesthesia Depth Monitoring, Analgesia Assessment, Perioperative Safety and Recovery, Target Controlled İnfusion
- Being tested
- Schnider+ Mİnto, Eleveld
- Keywords
- Hysteroscopy, Target-Controlled Infusion (TCI), Eleveld, Schnider, Minto, Consciousness Monitoring, Anesthetic Depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schnider+ MİntoDevice
Patients assigned to the Standart TCI model Group would have Schnider + Minto models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters.
EleveldDevice
Patients assigned to the Eleveld TCI model Group would have Eleveld+Eleveld models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters.
| Study group | Role | What they receive |
|---|---|---|
| Standart TCI model group | Patients in this group will receive general anesthesia using Target-Controlled Infusion (TCI) with the Schnider model for propofol and the Minto model for remifentanil. Receives: Device: Schnider+ Mİnto | |
| Eleveld TCI Model Group | Patients in this group will receive general anesthesia using the Eleveld model for both propofol and remifentanil Receives: Device: Eleveld |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Intraoperative Complications
Number of patients experiencing at least one predefined complication during anesthesia, including hypotension (MAP <65 mmHg >1 min), bradycardia (HR <50 bpm), or oxygen desaturation (SpO₂ <92%)
Measured: perioperative period: from beginning of anesthesia induction to discharge from recovery room
Total Recovery Time Until Discharge Readiness
Time elapsed from cessation of anesthetic agents to achieving an Aldrete score ≥9
Measured: Up to 2 hours post-anesthesia
Secondary outcomes (5)
Total Propofol Consumption
Total amount of propofol (mg) administered via TCI during the entire anesthetic period
Measured: From induction to end of anesthesia
Total Remifentanil Consumption
Total amount of remifentanil (mcg) administered via TCI during the entire anesthetic period
Measured: From induction to end of anesthesia
Patient and Surgeon Satisfaction and Willingness to Repeat the Same Anesthesia Method
The percentage of cases in which both the patient and the operating surgeon answered "Yes" to the question:
Patient: "Would you prefer the same anesthesia technique again in the future?" Surgeon: "Would you prefer the same anesthetic method for future similar cases?"
Measured: Patient: Within 1 hour postoperatively (before recovery room discharge) Surgeon: Immediately after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Number of patients who experience at least one episode of nausea and/or vomiting during the early recovery period
Measured: Within 2 hours after anesthesia discontinuation
Incidence of Postoperative Pain
Number of patients reporting a pain score ≥4 on a 0-10 Numerical Rating Scale (NRS) during recovery
Measured: Within 30 minutes after arrival in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start10 Apr 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Depth MonitoringStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Coşkun, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023263
- Sponsor's protocol ID
- 2024-KAEK-07
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Anesthesia Effectiveness in Hysteroscopy Cases Administered With Target-Controlled Infusion (TCI)
- ClinicalTrials.gov ID
- NCT07023263
- Acronym / sponsor ID
- 2024-KAEK-07
- Conditions
- Anesthesia Depth Monitoring, Analgesia Assessment, Perioperative Safety and Recovery, Target Controlled İnfusion
- Keywords
- Hysteroscopy, Target-Controlled Infusion (TCI), Eleveld, Schnider, Minto, Consciousness Monitoring, Anesthetic Depth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Jun 2025 (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 prospective, randomized, observational study aims to evaluate the perioperative anesthetic efficacy of different Target-Controlled Infusion (TCI) models-specifically Minto, Schnider, and Eleveld pharmacokinetic models-in patients undergoing hysteroscopy under general anesthesia. 90 female patients will be randomized into two groups, each receiving different TCI model combinations for propofol and remifentanil. Primary outcomes include intraoperative consciousness (BIS/SEF), analgesia (ANI), tissue oxygenation (NIRS), and recovery parameters. The study seeks to identify model-specific benefits regarding patient and surgeon satisfaction, recovery time, and complication rates.
Detailed description
This study aims to evaluate the perioperative anesthetic efficacy of target-controlled infusion (TCI) in hysteroscopy cases. The study will be conducted in the Gynecology and Obstetrics Operating Room located on the 9th floor of Gazi University Hospital between April 2025 and July 2025.
The study will include women aged 18-65 years who will undergo hysteroscopy and meet the criteria of ASA I-II classification, with no significant comorbidities and a BMI < 35. The study is planned in two groups, with each group consisting of 45 patients, totaling 90 participants.
In the first group, TCI protocols based on the Schnider and Minto models will be applied. The initial target concentrations for propofol and remifentanil infusion will be set at 5 µg/mL and 4 ng/mL, respectively. In the second group, the Eleveld model will be used. The propofol dose will be adjusted according to the patient's age using the Eleveld algorithm, and the remifentanil effect-site concentration will be maintained at 3 ng/mL.
Participants will be informed about the study, and those eligible and willing to participate will provide signed informed consent. Upon being brought to the operating room, intravenous access will be checked and established if not already in place. Non-invasive blood pressure, heart rate, and oxygen saturation will be monitored in accordance with ASA standards.
Following this, Masimo Root device with SedLine, NIRS, and ANI sensors will be attached to the appropriate sites on the patients, ensuring data flow. These sensors will continuously monitor the patient's level of consciousness, tissue oxygenation, and pain response.
The Braun Space Plus Perfusor will be utilized as the TCI device. Patient-specific data, including age, height, weight, and gender, will be entered, and the effect-site concentrations for propofol and remifentanil will be set according to the respective TCI model being applied. Once all settings are confirmed and the device is operational, TCI infusion will be initiated.
After achieving loss of consciousness, a Laryngeal Mask Airway (LMA) of appropriate size will be inserted, and the patient will be connected to a ventilator. During the procedure, TCI infusion rates will be adjusted to maintain a SedLine value between 25-50 for propofol and an ANI range of 50-70 for remifentanil, ensuring hemodynamic stability.
Throughout the operation, hemodynamic data, SedLine, NIRS, and ANI values will be continuously monitored and recorded at specified intervals in the Case Report Form (CRF). The concentrations and total amounts of propofol and remifentanil administered will also be regularly monitored and documented.
Upon completion of the surgical procedure and initiation of hemostasis, TCI infusion will be terminated. Patients with increased SedLine values will have their LMAs removed when appropriate, and those who are alert and without respiratory distress will be transferred to the recovery room. In this phase, hemodynamic parameters, VAS pain scores, Aldrete scores, and nausea/vomiting status will be assessed and recorded. Patients achieving an Aldrete score of 10, who are hemodynamically stable and without complications, will be transferred to the service ward.
Additionally, patient and surgeon satisfaction will be evaluated and recorded in the CRF. All data will be analyzed using SPSS 27.0 software. Intraoperative drug consumption, time to loss of consciousness, recovery duration, and complication rates will be analyzed using ANOVA. Correlation analyses will assess the relationships between drug consumption and recovery times.
Confidentiality will be strictly maintained throughout the study. Data will be accessible only to the research team and will be coded to ensure participant anonymity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standart TCI model group | – | Device: Schnider+ MİntoPatients in this group will receive general anesthesia using Target-Controlled Infusion (TCI) with the Schnider model for propofol and the Minto model for remifentanil. |
| Eleveld TCI Model Group | – | Device: EleveldPatients in this group will receive general anesthesia using the Eleveld model for both propofol and remifentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include female patients aged 18 to 65 years who are scheduled to undergo elective hysteroscopic surgery under general anesthesia. Eligible participants must be classified as ASA Physical Status I-II, with no significant comorbidities. All patients will provide written informed consent prior to enrollment. Patients with a history of significant cardiac, pulmonary, or neurological disease, known allergies to propofol or remifentanil, pregnancy or breastfeeding status, body mass index (BMI) >35, or substance use disorder will be excluded. A total of 90 patients will be randomized into two groups (45 patients each) to receive anesthesia with different TCI models. The study population is limited to a single academic tertiary care center (Gazi University Faculty of Medicine, Department of Anesthesiology and Reanimation).
Key inclusion criteria (4 listed)
- Female, aged 18-65
- ASA I-II
- Scheduled for hysteroscopy under general anesthesia
- Signed informed consent
Key exclusion criteria (5 listed)
- Allergy to study drugs
- Significant cardiac, pulmonary, neurological disease
- Pregnancy or breastfeeding
- BMI >35
- Substance use disorder
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 |
|---|---|---|
| Schnider+ MİntoPatients assigned to the Standart TCI model Group would have Schnider + Minto models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters. | Device | Standart TCI model group |
| EleveldPatients assigned to the Eleveld TCI model Group would have Eleveld+Eleveld models throughout the surgery. The patients would be monitorized with anesthesia depth, analgesia monitoring, NIRS, and recovery parameters. | Device | Eleveld TCI Model Group |
Primary outcome
Incidence of Intraoperative Complications
Time frame: perioperative period: from beginning of anesthesia induction to discharge from recovery room
Number of patients experiencing at least one predefined complication during anesthesia, including hypotension (MAP <65 mmHg >1 min), bradycardia (HR <50 bpm), or oxygen desaturation (SpO₂ <92%)
Total Recovery Time Until Discharge Readiness
Time frame: Up to 2 hours post-anesthesia
Time elapsed from cessation of anesthetic agents to achieving an Aldrete score ≥9
5 secondary outcomes
Total Propofol Consumption
Time frame: From induction to end of anesthesia
Total Remifentanil Consumption
Time frame: From induction to end of anesthesia
Patient and Surgeon Satisfaction and Willingness to Repeat the Same Anesthesia Method
Time frame: Patient: Within 1 hour postoperatively (before recovery room discharge) Surgeon: Immediately after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Within 2 hours after anesthesia discontinuation
Incidence of Postoperative Pain
Time frame: Within 30 minutes after arrival in the recovery room
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 15 Jun 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Depth Monitoring and Analgesia Assessment, run by Gazi University 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Complications (time frame: perioperative period: from beginning of anesthesia induction to discharge from recovery room). The study lists 2 primary outcomes in all. 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 15 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.