Postoperative DeliriumNCT02360982
The Comparison of Incidence and Risk Factors of Postoperative Delirium in Elderly Patients After Lower Extremity Surgery
An observational study of Postoperative Delirium, run by Cukurova University.
Trial summary
The aim of this study is to compare the risk factors and the incidence of delirium following orthopedic surgery under the general or regional anesthesia in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- propofol and esmeron(rokuronyum) and marcaine and fentanyl
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: American Society of Anesthesiologists physical status I-III, 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study.
Who may be able to join
- American Society of Anesthesiologists physical status I-III,
- 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery
Who cannot join
- Exclusion criteria were patient refusal, abuse of alcohol and/or drugs
- Hypersensitivity to local anesthetics
- Vertebral abnormality
- Previous lumbar vertebra surgery
- Coagulation disorder
- Infection (systemic or local)
Show all 11Show fewer
- Cerebrovascular disease
- Neurosurgery
- Vascular surgery
- Frequent use of analgesic drug
- ≥5 drugs per day and psychiatric medication
About this study
Official title: Cukurova University Faculty of Medicine
The aim of this study is to compare the risk factors and the incidence of delirium following orthopedic surgery under the general or regional anesthesia in elderly patients.
Read the detailed description
One hundred twenty elderly patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study. Patients were allocated into two groups to receive regional anesthesia (group R, n=50) or general anesthesia (group G, n=70). Hemodynamic and blood parameters, potential risk factors of delirium including age, sex, duration of surgery, the type of anesthesia, coexisting disease, smoking and amount of drug used delirium tests (CAM and DRS-R-98), hospital stay and costs were recorded for all patients.
- Conditions
- Postoperative Delirium
- Being tested
- propofol and esmeron(rokuronyum), marcaine and fentanyl
- Keywords
- Delirium, regional anesthesia, general anesthesia
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol and esmeron(rokuronyum)Behavioural
All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).
marcaine and fentanylBehavioural
All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).
| Study group | Role | What they receive |
|---|---|---|
| propofol and esmeron(rokuronyum) | In group G, anesthesia was induced with iv propofol (2 mg.kg-1) and maintained with 2% sevoflurane in a mixture of 65 % nitrous oxide and 35 % oxygen with a total gas flow rate of 6 L min-1. Neuromuscular relaxation was induced with iv rocuronium (esmeron) (0.5 mg.kg-1). Intravenous infusion of 0.9% saline was administered at a volume of 5 mL/kg/h. Patients received morphine (0.1mg/kg) for postoperative analgesia 30 minutes before the end of the operation. Anesthesia was terminated and neuromuscular blockade was antagonized with neostigmine (0.05 mg.kg-1)and atropine sulphate (0.01 mg.kg-1). Receives: Behavioral: propofol and esmeron(rokuronyum); Behavioral: marcaine and fentanyl | |
| marcaine and fentanyl | We inserted a 18-G Tuohy needle at the L3/L4 or L2/L3 intervertebral epidural space using an epidural loss of resistance technique and thus performed needle-through-needle technique for subarachnoid injection of 2 mL bupivacaine (marcaine)(0.5%) and fentanyl (25 mcg) by 27-G spinal needle. After subarachnoid injection, epidural catheter was advanced and fixed.
At the end of the surgery 5 mL of bupivacaine 0.5% plus morphine (1 mg), adding to 4 mL saline was injected via epidural catheter for postoperative analgesia.Epidural catheter was removed at 24th hours Receives: Behavioral: propofol and esmeron(rokuronyum); Behavioral: marcaine and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of postoperative delirium as defined by CAM criteria.
Measured: one year
Secondary outcomes (2)
severity of delirium rated with the DRS-R-9
Measured: one year
length of hospital stay and costs.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Cukurova University
- Investigators
- ILKE KUPELI, Principal investigator, MENGUCEK GAZI TRAINING AND RESEARCH HOSPITAL DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CAREERSEL GULEC, Study chair, CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CAREEBRU BIRICIK, Study chair, CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CAREAKIF MIRIOĞLU, Study chair, CUKUROVA UNIVERSITY DEPARTMENT OF ORTHOPEDICS AND TRAUMATOLOGYYASEMIN GUNES, Study chair, CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360982
- Sponsor's protocol ID
- cukurova university
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Litaker D, Locala J, Franco K, Bronson DL, Tannous Z. Preoperative risk factors for postoperative delirium. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):84-9. doi: 10.1016/s0163-8343(01)00117-7.
PubMed 11313076Schrader SL, Wellik KE, Demaerschalk BM, Caselli RJ, Woodruff BK, Wingerchuk DM. Adjunctive haloperidol prophylaxis reduces postoperative delirium severity and duration in at-risk elderly patients. Neurologist. 2008 Mar;14(2):134-7. doi: 10.1097/NRL.0b013e318166b88c.
PubMed 18332845Steiner LA. Postoperative delirium. Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011 Sep;28(9):628-36. doi: 10.1097/EJA.0b013e328349b7f5.
PubMed 21785356Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
PubMed 16540616Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.
PubMed 16803914Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.
PubMed 19690943Papaioannou A, Fraidakis O, Michaloudis D, Balalis C, Askitopoulou H. The impact of the type of anaesthesia on cognitive status and delirium during the first postoperative days in elderly patients. Eur J Anaesthesiol. 2005 Jul;22(7):492-9. doi: 10.1017/s0265021505000840.
PubMed 16045136Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.
PubMed 20042557Marcantonio E, Ta T, Duthie E, Resnick NM. Delirium severity and psychomotor types: their relationship with outcomes after hip fracture repair. J Am Geriatr Soc. 2002 May;50(5):850-7. doi: 10.1046/j.1532-5415.2002.50210.x.
PubMed 12028171Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.
PubMed 20069607Robinson 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.
PubMed 19106695McAlpine JN, Hodgson EJ, Abramowitz S, Richman SM, Su Y, Kelly MG, Luther M, Baker L, Zelterman D, Rutherford TJ, Schwartz PE. The incidence and risk factors associated with postoperative delirium in geriatric patients undergoing surgery for suspected gynecologic malignancies. Gynecol Oncol. 2008 May;109(2):296-302. doi: 10.1016/j.ygyno.2008.02.016. Epub 2008 Mar 28.
PubMed 18374970Schuurmans MJ, Duursma SA, Shortridge-Baggett LM, Clevers GJ, Pel-Littel R. Elderly patients with a hip fracture: the risk for delirium. Appl Nurs Res. 2003 May;16(2):75-84. doi: 10.1016/s0897-1897(03)00012-0.
PubMed 12764718Martin NJ, Stones MJ, Young JE, Bedard M. Development of delirium: a prospective cohort study in a community hospital. Int Psychogeriatr. 2000 Mar;12(1):117-27. doi: 10.1017/s1041610200006244.
PubMed 10798458
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cukurova University Faculty of Medicine
- ClinicalTrials.gov ID
- NCT02360982
- Acronym / sponsor ID
- cukurova university
- Conditions
- Postoperative Delirium
- Keywords
- Delirium, regional anesthesia, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the risk factors and the incidence of delirium following orthopedic surgery under the general or regional anesthesia in elderly patients.
Detailed description
One hundred twenty elderly patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study. Patients were allocated into two groups to receive regional anesthesia (group R, n=50) or general anesthesia (group G, n=70). Hemodynamic and blood parameters, potential risk factors of delirium including age, sex, duration of surgery, the type of anesthesia, coexisting disease, smoking and amount of drug used delirium tests (CAM and DRS-R-98), hospital stay and costs were recorded for all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol and esmeron(rokuronyum) | – | Behavioral: propofol and esmeron(rokuronyum), Behavioral: marcaine and fentanylIn group G, anesthesia was induced with iv propofol (2 mg.kg-1) and maintained with 2% sevoflurane in a mixture of 65 % nitrous oxide and 35 % oxygen with a total gas flow rate of 6 L min-1. Neuromuscular relaxation was induced with iv rocuronium (esmeron) (0.5 mg.kg-1). Intravenous infusion of 0.9% saline was administered at a volume of 5 mL/kg/h. Patients received morphine (0.1mg/kg) for postoperative analgesia 30 minutes before the end of the operation. Anesthesia was terminated and neuromuscular blockade was antagonized with neostigmine (0.05 mg.kg-1)and atropine sulphate (0.01 mg.kg-1). |
| marcaine and fentanyl | – | Behavioral: propofol and esmeron(rokuronyum), Behavioral: marcaine and fentanylWe inserted a 18-G Tuohy needle at the L3/L4 or L2/L3 intervertebral epidural space using an epidural loss of resistance technique and thus performed needle-through-needle technique for subarachnoid injection of 2 mL bupivacaine (marcaine)(0.5%) and fentanyl (25 mcg) by 27-G spinal needle. After subarachnoid injection, epidural catheter was advanced and fixed. At the end of the surgery 5 mL of bupivacaine 0.5% plus morphine (1 mg), adding to 4 mL saline was injected via epidural catheter for postoperative analgesia.Epidural catheter was removed at 24th hours |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- American Society of Anesthesiologists physical status I-III, 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I-III,
- 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery
Key exclusion criteria (11 listed)
- Exclusion criteria were patient refusal, abuse of alcohol and/or drugs
- Hypersensitivity to local anesthetics
- Vertebral abnormality
- Previous lumbar vertebra surgery
- Coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol and esmeron(rokuronyum)All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98). | Behavioural | marcaine and fentanyl, propofol and esmeron(rokuronyum) |
| marcaine and fentanylAll patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98). | Behavioural | marcaine and fentanyl, propofol and esmeron(rokuronyum) |
Primary outcome
the presence of postoperative delirium as defined by CAM criteria.
Time frame: one year
2 secondary outcomes
severity of delirium rated with the DRS-R-9
Time frame: one year
length of hospital stay and costs.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Background: PubMed 11313076Litaker D, Locala J, Franco K, Bronson DL, Tannous Z. Preoperative risk factors for postoperative delirium. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):84-9. doi: 10.1016/s0163-8343(01)00117-7.
- Background: PubMed 18332845Schrader SL, Wellik KE, Demaerschalk BM, Caselli RJ, Woodruff BK, Wingerchuk DM. Adjunctive haloperidol prophylaxis reduces postoperative delirium severity and duration in at-risk elderly patients. Neurologist. 2008 Mar;14(2):134-7. doi: 10.1097/NRL.0b013e318166b88c.
- Background: PubMed 21785356Steiner LA. Postoperative delirium. Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011 Sep;28(9):628-36. doi: 10.1097/EJA.0b013e328349b7f5.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 16540616Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
- Background: PubMed 16803914Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.
- Background: PubMed 19690943Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.
- Background: PubMed 16045136Papaioannou A, Fraidakis O, Michaloudis D, Balalis C, Askitopoulou H. The impact of the type of anaesthesia on cognitive status and delirium during the first postoperative days in elderly patients. Eur J Anaesthesiol. 2005 Jul;22(7):492-9. doi: 10.1017/s0265021505000840.
- Background: PubMed 20042557Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.
- Background: PubMed 12028171Marcantonio E, Ta T, Duthie E, Resnick NM. Delirium severity and psychomotor types: their relationship with outcomes after hip fracture repair. J Am Geriatr Soc. 2002 May;50(5):850-7. doi: 10.1046/j.1532-5415.2002.50210.x.
- Background: PubMed 20069607Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.
- Background: PubMed 19106695Robinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ILKE KUPELI principal investigator
MENGUCEK GAZI TRAINING AND RESEARCH HOSPITAL DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
ERSEL GULEC study chair
CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
EBRU BIRICIK study chair
CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Cukurova University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of postoperative delirium as defined by CAM criteria. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360982, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.