Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07023263

Target-Controlled Infusion (TCI) Effectiveness in Hysteroscopy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Gazi University

Ankara, 06590, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, aged 18-65
  • ASA I-II
  • Scheduled for hysteroscopy under general anesthesia
  • Signed informed consent

Exclusion criteria

  • Allergy to study drugs
  • Significant cardiac, pulmonary, neurological disease
  • Pregnancy or breastfeeding
  • BMI >35
  • Substance use disorder

Treatment and study plan

Schnider+ Mİnto

Device

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.

Eleveld

Device

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.

Primary outcomes

  1. 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%)

  2. 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

Secondary outcomes

  1. Total Propofol Consumption

    Time frame: From induction to end of anesthesia

    Total amount of propofol (mg) administered via TCI during the entire anesthetic period

  2. Total Remifentanil Consumption

    Time frame: From induction to end of anesthesia

    Total amount of remifentanil (mcg) administered via TCI during the entire anesthetic period

  3. 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

    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?"

  4. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: Within 2 hours after anesthesia discontinuation

    Number of patients who experience at least one episode of nausea and/or vomiting during the early recovery period

  5. Incidence of Postoperative Pain

    Time frame: Within 30 minutes after arrival in the recovery room

    Number of patients reporting a pain score ≥4 on a 0-10 Numerical Rating Scale (NRS) during recovery

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Evaluation of Perioperative Anesthesia Effectiveness in Hysteroscopy Cases Administered With Target-Controlled Infusion (TCI)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.