Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients

NCT06535230 | Recruiting

• 1 other identifier: ATADEK-2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients (American Society of Anesthesiologists risk scores III and IV) using target-controlled infusion (TCI) of propofol versus standard manual induction of anesthesia. Our previously published study compared TCI and manual induction of anesthesia in a general patient population and found that hypotension developed less with TCI induction. This study is a continuation of the other study and will be conducted in high-risk patients.

Conditions

Anesthesia; Hemodynamic Instability

Keywords

Anesthesia induction; Post-induction hypotension; Target controlled infusions; High-risk patients

Outcome Measures

Primary Outcomes (3)

• Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual

  Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Diastolic arterial pressure (DAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual

  Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Mean arterial pressure (MAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual

  Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion

  The duration of the study was defined from one minute before induction to 10 minutes after induction

Secondary Outcomes (7)

• Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia with TCI or manual

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI and manual

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual

  The duration of the study was defined from one minute before induction to 10 minutes after induction

• Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual

  The duration of the study was defined from one minute before induction to 10 minutes after induction

Study Arms (2)

Patients who were assigned to have manual anesthesia induction group with propofol

ACTIVE COMPARATOR

Patients who were assigned to have a manual anesthesia induction group, propofol was administered 1-2 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60

Drug: Manual anesthesia induction; Device: Hemodynamic monitoring with pressure recording analytical method (PRAM)

Patients who were assigned to have target controlled infusions ( TCI) induction with propofol

ACTIVE COMPARATOR

Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 1 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55

Drug: Anesthesia induction with Target controlled infusions (TCI); Device: Hemodynamic monitoring with pressure recording analytical method (PRAM)

Interventions

Manual anesthesia induction DRUG

In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight

Also known as: Manuel induction

Patients who were assigned to have manual anesthesia induction group with propofol

Anesthesia induction with Target controlled infusions (TCI) DRUG

Target controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms.

Also known as: TCI induction

Patients who were assigned to have target controlled infusions ( TCI) induction with propofol

Hemodynamic monitoring with pressure recording analytical method (PRAM) DEVICE

The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method.

Patients who were assigned to have manual anesthesia induction group with propofol; Patients who were assigned to have target controlled infusions ( TCI) induction with propofol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the American Society of Anesthesiology physical status 3-4
• Underwent major elective surgery
• Required intra-arterial blood pressure monitoring before induction.

You may not qualify if:

• Under 18 years of age
• Patients with the American Society of Anesthesiology physical status 1-2
• Arrhythmia (atrial fibrillation, frequent premature beat)
• Severe valvular heart disease
• Morbid obesity
• Intubation difficulty
• Drug addiction
• Treatment with opiates
• Pregnancy
• Emergency surgery

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.

  PMID: 33206118 BACKGROUND

• Sessler DI, Khan MZ, Maheshwari K, Liu L, Adegboye J, Saugel B, Mascha EJ. Blood Pressure Management by Anesthesia Professionals: Evaluating Clinician Skill From Electronic Medical Records. Anesth Analg. 2021 Apr 1;132(4):946-956. doi: 10.1213/ANE.0000000000005198.

  PMID: 33031346 BACKGROUND

• Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. doi: 10.1097/00000542-199412000-00013.

  PMID: 7992907 BACKGROUND

• Gao Q, Sun L. Hypotension during induction: prediction or prevention? J Anesth. 2020 Apr;34(2):308. doi: 10.1007/s00540-019-02710-9. Epub 2019 Nov 9. No abstract available.

  PMID: 31707517 BACKGROUND

• Kazama T, Ikeda K, Morita K, Kikura M, Doi M, Ikeda T, Kurita T, Nakajima Y. Comparison of the effect-site k(eO)s of propofol for blood pressure and EEG bispectral index in elderly and younger patients. Anesthesiology. 1999 Jun;90(6):1517-27. doi: 10.1097/00000542-199906000-00004.

  PMID: 10360846 BACKGROUND

• Yildirim SA, Dogan L, Sarikaya ZT, Ulugol H, Gucyetmez B, Toraman F. Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol. J Clin Med. 2023 Aug 14;12(16):5280. doi: 10.3390/jcm12165280.

  PMID: 37629322 BACKGROUND

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Fevzi Toraman, M.D.

  Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

  STUDY DIRECTOR

Central Study Contacts

Serap A Aktas Yildirim, MD

CONTACT

+905325605077; serapaktas79@yahoo.com.tr

Zeynep Tugce Sarikaya, M.D.

CONTACT

lredzheb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, non-blinded, randomized controlled trial. Patients were allocated to 2 groups: Group 1: Patients who underwent manual anesthesia induction Group 2 : Patients who underwent anesthesia induction with target-controlled infusion,

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 2, 2024
• Study Start: August 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)