Effect of Depth of Total Intravenous Anesthesia Using Propofol on Postoperative Cognitive Dysfunction

NCT01708837 | Unknown Phase 4 DMC

• 1 other identifier: ISSDIPR0003
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether the depth of anesthesia with propofol affects the incidence of early postoperative cognitive dysfunction

Conditions

Cognition Disorders

Keywords

Postoperative Cognitive Dysfunction; Bispectral index

Outcome Measures

Primary Outcomes (1)

• cognitive function score measured by Wechsler memory scale/ Wechsler intelligence scale manual

  cognitive function test using Wechsler memory scale/ Wechsler intelligence scale manual were administered the day before and 7 days and 3 months after surgery.

  Three month

Study Arms (2)

deep anesthesia group

OTHER

Propofol infusion rate is titrated to maintain the target BIS values in 30-45

Drug: Propofol

light anesthesia group

OTHER

Propofol infusion rate is titrated to maintain the target BIS values in 45-60

Drug: Propofol

Interventions

Propofol DRUG

Propofol infusion rate is titrated to maintain the target BIS values

deep anesthesia group; light anesthesia group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided by legal guardians or patients
• Male or female patients between 50 and 70 years of age.
• ASA physical status I or II patients.
• Education Years of patients are more than 6 years.
• The operation going to be received is the first operation in patient's life (a second operation was a risk factor for early post- operative cognitive dysfunction);
• The operation going to be received is presenting for a moderate surgery, such as pulmonary lobectomy, subtotal gastrectomy, prostatectomy and so on.

You may not qualify if:

• The patient has the history of neurologic or mental disease.
• The patient has renal dysfunction, serum creatinine \>177 mmol/L.
• The patient has an active liver disease.
• The patient has cardiac dysfunction.
• The patient has pulmonary dysfunction.
• The patient has an endocrine disease.
• The patient has a metabolic disease.
• The patient has a history of surgery.
• The patient is going to receive surgery of thyroid, intracranial procedure, joint replacement, major fracture.
• The patient's education history is shown less than 6 years of school.
• The patient is unable to complete neuropsychologic testing.
• The patient has vision dysfunction.
• The patient has auditory dysfunction.
• The operation going to be received is a laparoscopic surgery.
• The patient is hypersensitive to propofol or any other anesthetic agents.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

XiangYa Hospital, Central South University

Changsha, Hunan, 410078, China

Location

Related Publications (13)

• Newman S, Stygall.J: Neuropsychological outcome following cardiac surgery. The Brain and cardiac Surgery 2000: 21-49

  BACKGROUND

• Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.

  PMID: 9525362 BACKGROUND

• Rasmussen LS, Christiansen M, Rasmussen H, Kristensen PA, Moller JT. Do blood concentrations of neurone specific enolase and S-100 beta protein reflect cognitive dysfunction after abdominal surgery?ISPOCD Group. Br J Anaesth. 2000 Feb;84(2):242-4. doi: 10.1093/oxfordjournals.bja.a013410.

  PMID: 10743460 BACKGROUND

• Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.

  PMID: 14616316 BACKGROUND

• Johnson T, Monk T, Rasmussen LS, Abildstrom H, Houx P, Korttila K, Kuipers HM, Hanning CD, Siersma VD, Kristensen D, Canet J, Ibanaz MT, Moller JT; ISPOCD2 Investigators. Postoperative cognitive dysfunction in middle-aged patients. Anesthesiology. 2002 Jun;96(6):1351-7. doi: 10.1097/00000542-200206000-00014.

  PMID: 12170047 BACKGROUND

• Cai YR, Xue ZG, Zhu B: Risk factors contributing to post- operative cognitive dysfunction in elderly patients. The Journal of Clinical Anesthesiology 2006; 22: 608-610

  BACKGROUND

• Enlund M, Mentell O, Flenninger A, Horneman G, Ronquist G. Evidence of cerebral dysfunction associated with isoflurane- or propofol based anaesthesia for orthognathic surgery, as assessed by biochemical and neuropsychological methods. Ups J Med Sci. 1998;103(1):43-59. doi: 10.3109/03009739809178944.

  PMID: 9789971 BACKGROUND

• Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.

  PMID: 16115985 BACKGROUND

• Shim TS, Lee JH, Kim SY, Lim TH, Kim SJ, Kim DS, Kim WD. Cerebral metabolic abnormalities in COPD patients detected by localized proton magnetic resonance spectroscopy. Chest. 2001 Nov;120(5):1506-13. doi: 10.1378/chest.120.5.1506.

  PMID: 11713127 BACKGROUND

• Farag E, Chelune GJ, Schubert A, Mascha EJ. Is depth of anesthesia, as assessed by the Bispectral Index, related to postoperative cognitive dysfunction and recovery? Anesth Analg. 2006 Sep;103(3):633-40. doi: 10.1213/01.ane.0000228870.48028.b5.

  PMID: 16931673 BACKGROUND

• Newman S, Stygall J, Hirani S, Shaefi S, Maze M. Postoperative cognitive dysfunction after noncardiac surgery: a systematic review. Anesthesiology. 2007 Mar;106(3):572-90. doi: 10.1097/00000542-200703000-00023.

  PMID: 17325517 RESULT

• Abildstrom H, Rasmussen LS, Rentowl P, Hanning CD, Rasmussen H, Kristensen PA, Moller JT. Cognitive dysfunction 1-2 years after non-cardiac surgery in the elderly. ISPOCD group. International Study of Post-Operative Cognitive Dysfunction. Acta Anaesthesiol Scand. 2000 Nov;44(10):1246-51. doi: 10.1034/j.1399-6576.2000.441010.x.

  PMID: 11065205 RESULT

• Ni D, Shi X, Wu X：Incidence of Postoperative Cognitive Dys- function (POCD) in Aged-patients After General Anesthesia. China Anesthesia and Analgesia 2004; 6: 164-166

  RESULT

MeSH Terms

Conditions

Cognition Disorders; Postoperative Cognitive Complications

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Qulian Guo, PhD

  Xiangya Hospital, Central South University, Changsha, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: October 17, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 31, 2013

Record last verified: 2012-10

Locations

CN (1)