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Completed

NCT Number: NCT04077827

TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Saint Savvas" Hospital

Athens, 11522, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Propofol

Drug

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

Primary outcomes

  1. Εvaluating stress levels

    Time frame: 1 day during hospitalization

    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.

Secondary outcomes

  1. Evaluating pain levels between the 2 protocols with scales perioperatively

    Time frame: 1 day during hospitalization

    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) )

  2. Evaluating stress levels between the 2 protocols with scales

    Time frame: 1 day during hospitalization

    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

  3. Evaluating Patients' Sedation

    Time frame: Perioperatively

    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) ).

  4. Evaluating Patients' Sedation

    Time frame: Perioperatively

    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.

  5. Evaluating pain levels between the 2 protocols with scales in PACU

    Time frame: 1 day during hospitalization

    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

  6. Evaluating stress levels between the 2 protocols with scales

    Time frame: 1 day during hospitalization

    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

  7. Evaluating stress levels between the 2 protocols with scales

    Time frame: 1 day during hospitalization

    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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Saint Savvas Anticancer Hospital

Registry information

Official study title

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

Acronym: TIVA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2019
Registry last updated
Sep 10, 2020

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.

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