NCT04077827

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

August 23, 2019

Last Update Submit

September 8, 2020

Conditions

Breast Cancer

Keywords

Admnistration Fat TransferAutologous Fat TransferBreast ReconstructionTIVAvolatile anesthesiastress levelspain levels

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Evaluating pain levels between the 2 protocols with scales perioperatively

    1 day during hospitalization

  • Evaluating stress levels between the 2 protocols with scales

    1 day during hospitalization

  • Evaluating Patients' Sedation

    Perioperatively

  • Evaluating Patients' Sedation

    Perioperatively

  • Evaluating pain levels between the 2 protocols with scales in PACU

    1 day during hospitalization

  • +2 more secondary outcomes

Study Arms (2)

Total intravenous anesthesia

EXPERIMENTAL

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

volatile anesthesia

EXPERIMENTAL

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

Interventions

PropofolDRUG

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)

Also known as: remifentanyl, desflurane
Total intravenous anesthesiavolatile anesthesia

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years
  • Patients with cardiac problems
  • Patients with respiratory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Saint Savvas" Hospital

Athens, 11522, Greece

Location

Related Publications (1)

  • Kapritsou M, Bozas E, Stavrianos S, Salatas K, Plastiras A, Pistolas K, Fyrfiris N, Kotrotsiou M, Konstantinou EA. The Total Intra Venous Anesthesia Effect Versus Volatile Anesthesia, on Stress and Pain Levels, in Patients Undergoing Breast Reconstruction in Ambulatory Surgery Center Total Intra Venous Anesthesia Protocol and Stress Response. Biol Res Nurs. 2024 Jan;26(1):91-100. doi: 10.1177/10998004231194571. Epub 2023 Aug 9.

    PMID: 37559349DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PropofolRemifentanilDesflurane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Evangelos Konstantinou, RN, PhD

    National and Kapodistrian University of Athens

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2019

First Posted

September 4, 2019

Study Start

September 1, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)