Neuroplasticity Induced by General Anaesthesia

NCT04125121 | Completed DMC

• 1 other identifier: H-18028925
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. In addition, to explore possible associations between neuroplastic changes and clinical and/or biochemical outcomes. It is a randomised, cross-over, single blinded clinical study. N = 30. Female:male ratio 1:1.

Conditions

Healthy Volunteers; General Anaesthesia; Neuroplasticity

Keywords

Neuroplasticity; Neuroplastic changes; General anaesthesia; Magnetic resonance imaging; Sevoflurane; Propofol; Healthy volunteers; Consciousness; Cognitive; Fatigue

Outcome Measures

Primary Outcomes (2)

• Changes in T1w3D

  Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI.

  8 days

• Changes in DTI

  White matter microstructure as measured using Diffusion Tensor Imaging (DTI)

  8 days

Secondary Outcomes (3)

• Changes in rsfMRI

  8 days

• Changes in fatigue

  8 days

• Cognitive performance

  8 days

Study Arms (2)

Sevoflurane-Propofol

ACTIVE COMPARATOR

Session one: Sevoflurane as maintenance anaesthetic during general anaesthesia. Session two: Propofol as maintenance anaesthetic during general anaesthesia.

Drug: Sevoflurane-propofol

Propofol-Sevoflurane

ACTIVE COMPARATOR

Session one: Propofol as maintenance anaesthetic during general anaesthesia. Session two: Sevoflurane as maintenance anaesthetic during general anaesthesia.

Drug: Sevoflurane-propofol

Interventions

Sevoflurane-propofol DRUG

General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.

Also known as: Propofol-sevoflurane

Propofol-Sevoflurane; Sevoflurane-Propofol

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 and ≤35.
• Healthy individual.
• BMI ≥18 kg/m2 and ≤30kg/m2.
• Normal electrocardiogram (ECG).
• Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
• American Society of Anaesthesiologists (ASA) class 1.
• Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details.
• Right-handed.
• Female participants must use safe contraceptives (hormonal or mechanical, including intrauterine devices).
• Speaks and understand Danish.
• Provides oral and written informed consent.

You may not qualify if:

• Contraindications to MRI.
• Left-handedness or ambidexterity.
• History of complications to general anaesthesia, including malignant hyperthermia.
• Family history of malignant hyperthermia.
• Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives.
• Allergy to any kind of medication or material to which the volunteer could be exposed during this study.
• History of serious illness.
• History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness.
• Surgery less than six weeks prior to the study period.
• Infection (with fever) less than two weeks prior to or during the study sessions.
• Daily use of any medication (not counting contraceptives).
• Consumed anti-depressants during the last 30 days before study days.
• Weakly intake of \>21 (for females \>14) units of alcohol.
• Heavy intake of caffeine (\> 5 cups/day).
• Smoking during the last 30 days before study days.

Sponsors & Collaborators

• Signe Sloth Madsen: lead

Study Sites (2)

Department of Neuroanaesthesiology

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Related Publications (65)

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Related Links

• Bigelow, Henry Jacob: Insensibility during Surgical Operations Produced by Inhalation. The Boston Medical and Surgical Journal. 1846, Volume 35, Issue 16, pp. 309-317.
• American Society of Anesthesiologists Physical Status Classification System
• Danish Society for Anaesthesiology and Intensive Care recommendation for post-anaesthesia observation
• Danish Society for Anaesthesiology and Intensive Care recommendation for discharge after anaesthesia
• Danish Medicines Information webpage

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Signe Madsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will not be present during randomisation. The participants will be anaesthetised when the investigational drug (maintenance anaesthetic) is administered, and will thus not be aware what type of anaesthesia is administered in which (otherwise identical) session.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomisation to one of two options in session 1: sevoflurane or propofol. In session 2, the remaining option is administered.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: September 26, 2019
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)