Target-Controlled Infusion (TCI) Effectiveness in Hysteroscopy

NCT07023263 | Active Not Recruiting FDA Device

• 1 other identifier: 2024-KAEK-07
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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%)

  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

  Up to 2 hours post-anesthesia

Secondary Outcomes (5)

• Total Propofol Consumption

  From induction to end of anesthesia

• Total Remifentanil Consumption

  From induction to end of anesthesia

• Patient and Surgeon Satisfaction and Willingness to Repeat the Same Anesthesia Method

  Patient: Within 1 hour postoperatively (before recovery room discharge) Surgeon: Immediately after surgery

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Within 2 hours after anesthesia discontinuation

• Incidence of Postoperative Pain

  Within 30 minutes after arrival in the recovery room

Study Arms (2)

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.

Device: Schnider+ Mİnto

Eleveld TCI Model Group

Patients in this group will receive general anesthesia using the Eleveld model for both propofol and remifentanil

Device: Eleveld

Interventions

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.

Standart TCI model group

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.

Eleveld TCI Model Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Ankara, 06590, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 15, 2025
• Study Start: April 10, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)