Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium

Postoperative Delirium Clinical Trial

— AG-DPO  

Official title:

Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705728
• Other study ID #: AG-DPO
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Centre Clinical, France
• Contact: Xavier Paqueron, MD PhD
• Phone: +33545979562
• Email: xavier.paqueron[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.

Description:

Scientific background Postoperative delirium (POD) is a common complication occurring in 5 to 50 % of elderly patients following an operation. Delirium is a serious complication leading to many medical as well as social and economical consequences. Several studies suggest that, both, the choice of anesthetic agents and the conduction of anesthesia might decrease the incidence of POD.

Objectives Study goal and primary aim: the intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of POD, compared with an inhalational anesthesia.

The primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS).

Secondary aims:

Secondary aim 1: Assessment of a potential difference on the incidence of PONV between the 2 groups of patients (i.e. intravenous vs. inhaled) by comparison of the number of episodes of nausea and vomiting and the need to treat this complications, between both groups.

Secondary aim 2: study if the difference of in the impairment of cognitive function might be correlated either with the type of drugs used to conduct anesthesia or with the control the index of cerebral activity (i.e. the BIS). The respective influences of the control of the index of cerebral activity (i.e. the BIS) and of the anesthetic drugs on the occurrence of postoperative cognitive dysfunctions (POCD) will be assessed by comparing cognitive function tests on matched groups on the percentage of time spent in different ranges of values of the cortical index Population of patients Patients of 60 years old or more, having given their written informed consent and who should undergo a surgical procedure of at least one hour.

Inclusion criterion

Patients will be included in the study if:

• They are 60 years old or older,

• They have given their written informed consent,

• They have to undergo a surgical procedure of one hour or longer. Non-inclusion criterion

Following patients will non be eligible for the current study:

• Pregnant women,

• Patients presenting a contra-indication to the monitoring of cerebral activity (i.e. intracranial surgery, neuroleptic or anti epileptic medications, pace maker),

• Patients presenting any allergy to propofol and or remifentanil,

• Patients under guardianship. Experimental protocol Information and inclusion of patients during the preoperative anesthetic assessment consultation First assessment of the NDSS at patient arrival in the operating room Randomization prior to the induction on the anesthesia Second NDSS just before patient leaving of PACU Recording of all PONV event as well as any administration of anti emetic drug

Number of subjects: 1000 Number of center: 4 Duration of the research: 36 months

Statistical Analysis: Sequential group analysis. The preoperative and postoperative NDSS test will be analyzed with an ANOVA for repeated-measure and multiple-comparison.

The main criterion will be analyzed with a Kaplan-Meier survival analysis on the global data and with a Cox regression that will take into account the qualitative factors represented by the type of anesthesia

Description of the Nursing Delirium Screening Scale (NDSS) that is a validated scale to assess POD at the bedside.

Five areas are assessed: disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation Description A screening tool designed for nurses to use at the end of their shift to identify patients with delirium, derived from the Confusion Rating Scale (CRS). Raters reference behaviors that they have witnessed in the patient or that the patient'snurse has witnessed during their shift to score the NDSS.

The NDSS can be rated one or more times daily.

Scoring information Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.

Positive NDSS is score ≥ 2, maximum total score is 10.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 59 year

• Informed written consent before enrolment;

• Procedure duration > 60 min.

• Speaking French

• Possible contact one-month following surgery

Exclusion Criteria:

• Contraindication of brain monitoring (intracranial surgery), pace-maker.

• Propofol or remifentanil allergy.

• Patients under guardianship

Related Conditions & MeSH terms

• Delirium
• Drug-Related Side Effects and Adverse Reactions
• Elderly Patient
• General Anesthetic Drug Adverse Reaction
• Postoperative Delirium

Intervention

Drug:
• Propofol
Propofol will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval
• Sevoflurane
Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval
• Remifentanil automatic
Remifentanil will be automatically administered according to the "EasyTIVA" device algorythm to maintain the BIS value within the 40-60 interval
• Remifentanil manual
Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval

Locations

Country	Name	City	State
France	Centre Clinical	Soyaux	Charente

Sponsors (1)

Lead Sponsor	Collaborator
Centre Clinical, France

Country where clinical trial is conducted

France, 

References & Publications (12)

American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. — View Citation

Besch G, Liu N, Samain E, Pericard C, Boichut N, Mercier M, Chazot T, Pili-Floury S. Occurrence of and risk factors for electroencephalogram burst suppression during propofol-remifentanil anaesthesia. Br J Anaesth. 2011 Nov;107(5):749-56. doi: 10.1093/bja/aer235. Epub 2011 Aug 8. — View Citation

Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba. — View Citation

Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. — View Citation

Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989. — View Citation

Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13. — View Citation

Liu N, Chazot T, Trillat B, Michel-Cherqui M, Marandon JY, Law-Koune JD, Rives B, Fischler M; Foch Lung Transplant Group. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):611-5. doi: 10.1053/j.jvca.2008.04.022. Epub 2008 Jun 25. — View Citation

Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10. — View Citation

Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015 Apr;122(4):759-67. doi: 10.1097/ALN.0000000000000577. — View Citation

Radtke FM, Franck M, Lendner J, Krüger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28. — View Citation

Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776. — View Citation

Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia	occurrence of POD as measured by the Nursing Delirium Screening Scale; The Nursing Delirium Scale; Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points; Total score = 2 points > 2 points Delirium No Yes	Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively