Sedation and Neuromediators Concentration

NCT04695509 | Completed DMC

• 1 other identifier: 502
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol (Propofol Kabi, Registration number from the State Register of Medicines - 000875) is a widely used intravenous anesthetic. It is well known about different effects of propofol infusion, including euphoria, psycholalia, disinhibition, talkativeness, satisfaction etc. However, the basic mechanisms of such effects remain unknown. We suppose that propofol sedation with various levels of sedation (from light to deep) leads to neuromediators changes. We examine dopamine, noradrenaline, acetylcholine, GABA and serotonin in peripheral venous blood before, during and after propofol sedation. Therefore, we suppose drugs for sedation, in particular, propofol will affect neuromediators concentration.

Conditions

Moderate Sedation; Deep Sedation

Keywords

Sedation; Neuromediators

Outcome Measures

Primary Outcomes (5)

• Dopamine concentration changes during moderate and deep sedation

  Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on dopamine concentration

  2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) dopamine conducting

• Serotonin concentration changes during moderate and deep sedation

  Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on serotonin concentration

  2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) serotonin conducting

• GABA concentration changes during moderate and deep sedation

  Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on GABA concentration

  2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) GABA conducting

• Acetylcholine concentration changes during moderate and deep sedation

  Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on acetylcholine concentration

  2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) acetylcholine conducting

• Noradrenaline concentration changes during moderate and deep sedation

  Venous blood sampling and enzyme-linked immunosorbent assay (ELISA) are used to evaluate the influence of medical sedation on noradrenaline concentration

  2 months for each patient from venous blood sampling to enzyme-linked immunosorbent assay (ELISA) noradrenaline conducting

Secondary Outcomes (3)

• Target control infusion (TCI) values of propofol sedation

  intraoperative period

• Richmond agitation and sedation scale (RASS) scores

  intraoperative period

• Bispectral index monitoring (BIS) values during moderate and deep sedation

  intraoperative period

Study Arms (2)

moderate sedation

EXPERIMENTAL

patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with moderate propofol sedation

Drug: moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3"

deep sedation

EXPERIMENTAL

Arm Description: patients with American Society of Anesthesiologists (ASA I-II), Montreal cognitive assessment test ≥ 26, trauma surgery under regional anesthesia with deep propofol sedation

Drug: deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4")

Interventions

moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) "-2" - "-3" DRUG

Two peripheral venous blood catheters are placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, noninvasive blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol light-moderate sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C\*. After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).

moderate sedation

deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) "-4") DRUG

Two peripheral venous blood catheter is placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol deep sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C\*. After 26 patients are recruited, the blood plasma is analyzed by conducting enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).

deep sedation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age ≥ 18 years
• Elective trauma surgery (arthroscopy, reconstructive foot surgery, osteosynthesis of intra-and periarticular fractures of the proxymal humerus) under regional anesthesia (spinal anesthesia or brachial plexus block) with propofol sedation
• Montreal cognitive assessment test ≥ 26
• Patients with American Society of Anesthesiologists (ASA) I-II
• Not written informed consent
• Age˂18 years
• Allergy to sedation drugs
• Pregnancy
• Epilepsy anamnesis
• II-III degree atrioventricular block
• Montreal cognitive assessment test ˂ 26
• Patients with American Society of Anesthesiologists (ASA) ˃ II
• The presence of psychiatric disorders
• Сancer patients with a life expectancy of less than two years

You may not qualify if:

• Patient refuse from further participation
• Transition from sedation to general anesthesia
• Allergy on anesthesia drugs during perioperative period

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

City Clinical Hospital № 31 of the Department of Health of Moscow

Moscow, Russia

Location

Related Links

• Related Info
• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 5, 2021
• Study Start: October 5, 2020
• Primary Completion: January 15, 2021
• Study Completion: April 15, 2021
• Last Updated: June 10, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available 11/01/2021

Locations

RU (1)