TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction (TIVA)

TIVA Versus Volatile Anesthetics Admnistration on Stress and Pain Levels During Autologous Fat Transfer in Breast Reconstruction, in a Day Care Center

The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day Care Center.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Propofol

Detailed Description

The sample of the study will be patients who will have Autologous Fat Transfer for Breast Reconstruction.

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile anesthetics (desflurane-remifentanil).

Specifically, the TIVA group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. Patients with cardiac and respiratory problems will be included in the DES group.

The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age), Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and perioperative pain levels will be assessed with CPOT scale (values 0-8).

Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b. How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS questions will also be given preoperatively and postoperatively to the ward. The sedation levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The level of patient's awareness will be assessed by GCS Scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)).

The presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. Finally, post-operative stress will be examined with stress biomarkers, salivary ACTH hormone and salivary cortisol hormone.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11522
    • "Saint Savvas" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

TIVA group

• patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III
• age >50 years
• high risk of nausea / vomiting
• high risk of postoperative delirium
• suspicion of malignant hyperthermia.

Volatile anesthesia

• patients with American Society of Anesthesiologists (ASA) PHYSICALSTATUS CLASSIFICATION SYSTEM I-III
• 20-70 years
• Patients with cardiac problems
• Patients with respiratory problems

Exclusion Criteria

•In both groups, the exclusion criteria are the opposite of the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total intravenous anesthesia; The patients will recieve intravenous anesthesia (propofol-remifentanyl) Recommended dosage: Propofol: Induction dosage 1,5-2,5 mg/kg Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI	Drug: Propofol; Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil); Other Names: remifentanyl; desflurane
Experimental: volatile anesthesia; The patients will recieve volatile anesthesia (desflurane-remifentanyl) Recommended dosage: Desflurane dosage 6-7 MAC Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI	Drug: Propofol; Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil); Other Names: remifentanyl; desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Εvaluating stress levels	Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples. Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples in patients after breast recostruction in a day care center. These measures will occured in three phases a. preoperatively, b. perioperatively c. in the PACU phase.	1 day during hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating pain levels between the 2 protocols with scales perioperatively	Evaluating perioperative pain levels between the two protocols with scale such as Critical Care Pain Observational Tool (CPOT scale, range 0-8(with a score of 0 = None and 8 = severe pain) )	1 day during hospitalization
Evaluating stress levels between the 2 protocols with scales	Evaluating perioperative stress levels between the two protocols with scale, such as the self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how sad are you feeling?in two phases: a. preoperatively, b) in PACU	1 day during hospitalization
Evaluating Patients' Sedation	Evaluation with Richmond Agitation-Sedation Scale (RASS scale, range +4 to -5, (with a score of -5 = unarousable and +4 = violent, immediate danger for the staff) ).	Perioperatively
Evaluating Patients' Sedation	Evaluation with Bispectral index (BIS, range 0-100). A BIS score quantifies changes in the electrophysiologic state of the brain during anesthesia. In patients who are awake, a typical BIS score is 90 to 100. Complete suppression of cortical activity results in a BIS score of 0, known as a flat line. Lower numbers indicate a higher hypnotic effect. Overall, a BIS value below 60 is associated with a low probability of response to commands.	Perioperatively
Evaluating pain levels between the 2 protocols with scales in PACU	Evaluating perioperative pain levels between the two protocols with scale such as Visual analogu pain scale (VAS, range 0-10, (with a score of 0 = None and 10 = severe pain) ) in PACU	1 day during hospitalization
Evaluating stress levels between the 2 protocols with scales	Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how stressed are you feeling, in two phases: a. preoperatively, b) in PACU	1 day during hospitalization
Evaluating stress levels between the 2 protocols with scales	Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how optimistic are you feeling, in two phases: a. preoperatively, b) in PACU	1 day during hospitalization

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: Saint Savvas Anticancer Hospital
• Investigators: Study Director: Evangelos Konstantinou, RN, PhD, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: TIVA; Breast Reconstruction; Admnistration Fat Transfer; Autologous Fat Transfer; volatile anesthesia; stress levels; pain levels
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane
• Other Study ID Numbers: 2834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No