TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

NCT ID: NCT04077827

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-03-30

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

remifentanyl; desflurane

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint Savvas Anticancer Hospital

OTHER

Sponsor Role: collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Maria Kapritsou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evangelos Konstantinou, RN, PhD

Role: STUDY_DIRECTOR

National and Kapodistrian University of Athens

Locations

"Saint Savvas" Hospital

Athens, , Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 37559349 (View on PubMed)

Other Identifiers

2834

Identifier Type: -

Identifier Source: org_study_id