NCT05045170

Brief Summary

The study of plasticity processes, in particular, memory, is one of the fundamental directions in anesthesiology. To date, there are different views on the impact of sedation and anesthesia on memory. Memory consolidation is one of the most crucial processes that the anesthesiologist is interested in. Memory consolidation is the mechanism of transferring short-term memory to long-term memory. The investigators suppose that propofol or dexmedetomidine sedation disrupts memory consolidation. In addition, the investigators inquired about the impact of sedation on 'working memory'. Therefore, a better understanding of the influence of anesthesia and sedation on basic memory processes will allow the anesthesiologist to balance the choice of the drug and ensure the patient's safety in the intraoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
Last Updated

February 9, 2022

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

September 6, 2021

Last Update Submit

February 7, 2022

Conditions

Memory ImpairmentAmnesiaRecallRecognition

Keywords

sedationMemory consolidationPropofolDexmedetomidine

Outcome Measures

Primary Outcomes (3)

  • memory consolidation impairment with propofol sedation

    Memorizing emotionally neutral words before, during and after propofol sedation. Evaluation of recall and recognition of words 24 hours after anesthesia.

    24 hours after the end of anesthesia

  • memory consolidation impairment with dexmedetomidine sedation

    : Memorizing emotionally neutral words before, during and after dexmedetomidine sedation. Evaluation of recall and recognition of words 24 hours after anesthesia.

    24 hours after the end of anesthesia

  • memory consolidation impairment without sedation

    Memorizing emotionally neutral words before, during and after operation. Evaluation of recall and recognition of words 24 hours after anesthesia.

    24 hours after the end of anesthesia

Secondary Outcomes (3)

  • 'working memory' impairment with propofol sedation

    5 minutes after memorizing emotionally neutral words during propofol sedation

  • 'working memory' impairment with dexmedetomidine sedation

    5 minutes after memorizing emotionally neutral words during dexmedetomidine sedation

  • 'working memory' impairment without sedation

    5 minutes after memorizing emotionally neutral words during operation

Study Arms (3)

propofol group

EXPERIMENTAL

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

Drug: Influence of propofol sedation on memory consolidation and 'working memory'

dexmedetomidine group

EXPERIMENTAL

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

Drug: Influence of dexmedetomidine sedation on memory consolidation and 'working memory'

control group

PLACEBO COMPARATOR

patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test≥26, trauma surgery under spinal anesthesia without sedation

Drug: Influence of spinal anesthesia on memory consolidation and 'working memory'

Interventions

Influence of propofol sedation on memory consolidation and 'working memory'DRUG

Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to propofol sedation (stage 1), 5-10 minutes after the start of propofol sedation (stage 2), 10 minutes after propofol sedation is finished and consciousness is restored (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.

propofol group
Influence of dexmedetomidine sedation on memory consolidation and 'working memory'DRUG

Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to dexmedetomidine sedation (stage 1), 5-10 minutes after the start of dexmedetomidine sedation (stage 2), 10 minutes after dexmedetomidine sedation is finished and consciousness is restored (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.

dexmedetomidine group
Influence of spinal anesthesia on memory consolidation and 'working memory'DRUG

Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to operation (stage 1), 5-10 minutes after the start of operation (stage 2), 10 minutes before the end of operation (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age ≥ 18 and ≤70 years
  • Elective trauma surgery (arthroscopy, reconstructive foot surgery) under regional anesthesia (spinal anesthesia) with propofol, dexmedetomidine or without sedation
  • Montreal cognitive assessment test ≥ 26
  • Patients with American Society of Anesthesiologists (ASA) I-II
  • Not written informed consent to participate in the research and/or perform regional blockade
  • Age˂18 and ˃70 years
  • Allergy to propofol, dexmedetomidine, lidocaine, bupivacaine
  • Pregnancy
  • Epilepsy anamnesis
  • II-III degree atrioventricular block
  • Montreal cognitive assessment test ˂ 26
  • Patients with American Society of Anesthesiologists (ASA) ˃ II
  • Emergency operation
  • The presence of psychiatric disorders
  • +2 more criteria

You may not qualify if:

  • Patient refuse from further participation
  • Ineffective spinal anesthesia
  • Allergy on anesthesia drugs during perioperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

Memory DisordersAmnesia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Vyacheslav Churakov, PgS

    I.M. Sechenov First Moscow State Medical University (Sechenov University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not aware of the drug used for sedation
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

May 11, 2021

Primary Completion

January 13, 2022

Study Completion

January 13, 2022

Last Updated

February 9, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will become available 31.10.2021

Locations

RU(1)