Monitoring of Adequate Course of General Anesthesia

NCT03331692 | Completed

• 1 other identifier: 06101968-05
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical monitoring is the most common method of adjustment of the appropriate level of general anesthesia. However, the episodes of intraoperative awareness are still reported, suggesting that clinical observations may not be sufficient in some cases. The objective of the study was to compare the efficacy of clinical and instrumental neuromonitoring with auditory evoked potentials in intraoperative analysis of the proper level of general anesthesia. The patients scheduled for elective surgery were included into the study, and randomly divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was analyzed with standard clinical parameters. All the participants were instrumentally monitored with AAI index. After the anesthesia patients received a questionnaire with the questions regarding possible intraoperative awareness.

Conditions

Monitoring of Depth of Anesthesia; AAI Index

Outcome Measures

Primary Outcomes (1)

• Changes in AAI values in selected (16) time points.

  T1: after premedication, just before the onset of anesthesia; T2: 30 seconds after intravenous administration of propofol; T3: just before the endotracheal intubation; T4: 60 seconds after the endotracheal intubation; T5: 5 minutes after the endotracheal

Study Arms (2)

TIVA group

OTHER

The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under totally intravenous anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.

Other: monitoring of the proper level of general anesthesia

VA group

OTHER

The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under volatile anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.

Other: monitoring of the proper level of general anesthesia

Interventions

monitoring of the proper level of general anesthesia OTHER

The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.

Also known as: clinical monitoring, instrumental monitoring

TIVA group; VA group

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for ENT procedures or discectomy,
• preoperative health status I or II according to ASA score.

You may not qualify if:

• patients below 18 or above 61 year old,
• ASA status III or higher,
• patients suffering from: (i) hearing problems or tinnitus, (ii) chronic inflammation of the ear, (iii) epilepsy, and (iv) mental disorders,
• pregnancy.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy

Warsaw, 04-141, Poland

Location

Related Publications (7)

• Saper CB, Chou TC, Scammell TE. The sleep switch: hypothalamic control of sleep and wakefulness. Trends Neurosci. 2001 Dec;24(12):726-31. doi: 10.1016/s0166-2236(00)02002-6.

  PMID: 11718878 BACKGROUND

• Nelson LE, Guo TZ, Lu J, Saper CB, Franks NP, Maze M. The sedative component of anesthesia is mediated by GABA(A) receptors in an endogenous sleep pathway. Nat Neurosci. 2002 Oct;5(10):979-84. doi: 10.1038/nn913.

  PMID: 12195434 BACKGROUND

• Lu J, Nelson LE, Franks N, Maze M, Chamberlin NL, Saper CB. Role of endogenous sleep-wake and analgesic systems in anesthesia. J Comp Neurol. 2008 Jun 1;508(4):648-62. doi: 10.1002/cne.21685.

  PMID: 18383504 BACKGROUND

• Ghoneim MM, Block RI, Haffarnan M, Mathews MJ. Awareness during anesthesia: risk factors, causes and sequelae: a review of reported cases in the literature. Anesth Analg. 2009 Feb;108(2):527-35. doi: 10.1213/ane.0b013e318193c634.

  PMID: 19151283 BACKGROUND

• Wang DS, Orser BA. Inhibition of learning and memory by general anesthetics. Can J Anaesth. 2011 Feb;58(2):167-77. doi: 10.1007/s12630-010-9428-8. Epub 2010 Dec 23.

  PMID: 21181566 BACKGROUND

• Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.

  PMID: 15333419 BACKGROUND

• Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. doi: 10.1016/s0163-8343(01)00142-6.

  PMID: 11543846 BACKGROUND

MeSH Terms

Interventions

Clinical Trials Data Monitoring Committees

Intervention Hierarchy (Ancestors)

Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: During the anesthesia, in all the participants an AAI-A line ARX index was continuously monitored. The electrodes were placed after the induction of anesthesia. Intraoperatively, both auditory evoked potentials with AAI index and electroencephalogram with burst suppression analysis was recorded. Recorded data were blinded for anesthesiologists, so were not used for analysis of level of anesthesia during surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Model Details: Participants are assigned to intravenous or volatile anesthesia. In both groups both the clinical and instrumental monitoring of the proper level of anesthesia was analyzed.

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 6, 2017
• Study Start: April 20, 2012
• Primary Completion: August 30, 2013
• Study Completion: July 14, 2014
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)