Back to resultsEffect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
Primary Purpose
Patients Undergoing Major Abdominal Surgery, Postoperative Confusion
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Remifentanil
Fentanyl
Sponsored by
About this trial
This is an interventional screening trial for Patients Undergoing Major Abdominal Surgery focused on measuring Major abdominal surgery, analgesic method, Fentanyl, Remifentanyl, Postoperative cognitive disorder, Pro and anti inflammatory cytokines
Eligibility Criteria
Inclusion Criteria:
- Age over 60 years
- Patients undergoing major abdominal surgery, in General Anesthesia
- ASA class status I-III
Exclusion Criteria:
- History of allergy to drugs used in the study
- Mini-Mental State Examination (MMSE) value < 26
- Expected duration of anesthesia less than 1 hour and more than 4 hours
- Presence of a cognitive disorder severity of overt such as to prevent collaboration of the patient
- Presence of severe electrolyte disturbances or not controlled bool glucose levels
- History of pain or cerebral vascular disease on the basis of significant carotid or cerebral artery stenosis, to be verified by scanning eco-color doppler
- Habitual use of tranquillizers or other drugs affecting the central nervous system
- Difficulties in the management of the airways, such as to make the necessary changes in anesthesia technique
- Severe hypotension or hypertension or other vascular disorders, particularly thrombotic events or bleeding during surgery or in the perioperative period
- Bleeding that requires blood transfusion
- Medication needs higher or lower than that indicated in the protocol to ensure the depth of hypnosis, indicated by values of BIS targets
- Refusal by the patient
Sites / Locations
- Policlinico Universitario "A.Gemelli"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remifentanyl
Fentanyl
Arm Description
In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.
In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.
Outcomes
Primary Outcome Measures
Rey verbal memory test of words before and after major abdominal surgery
In test of Rey to the subject is presented for 5 times the same list of 15 bisyllabic words or trisillabic common use of which he must recall as many as possible within 1 minute; after about 15 minutes the patient, meanwhile distracted by the test , must again try to remember the greatest number possible without a further reading. The maximum possible score of the first phase of the test is an expression of the ability of short term memory of the subject, the result of the test is repeated at a distance of 15 minutes is indicative of its storage capacity, to intermediate term.
Stroop Test before and after surgery
In the Stroop Test patient is instructed to read a random sequence of adjectives "green", "red", "blue" written in black font, then he refers the colour of a succession of circumferences filled of the three colors above in random order; finally, another random succession of three words "green", "red", "blue" written in three characters of the same colors, but not associated with corresponding adjective. Number of errors that the subject does in reading is an indication of its ability to attention
Secondary Outcome Measures
Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery
Blood samples will be made for the quantitative determination of serum cytokines IL-1β, IL-6, IL-8, TNF-α, IL-10 and IL-12. Determinations will be given by Multiplex Elisa method.
Full Information
NCT ID
NCT01627873
First Posted
June 21, 2012
Last Updated
June 22, 2012
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01627873
Brief Title
Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
Official Title
Effect of Remifentanil on Postoperative Cognitive Function in Patients Undergoing Major Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients.
Detailed Description
The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients. In particular, whether there is a correlation between type of anesthesia and the appearance of postoperative cognitive disorder (POCD), including type of anesthesia and levels of pro and anti inflammatory cytokines and investigate whether there is an association between presence or absence of POCD and cytokines levels
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Major Abdominal Surgery, Postoperative Confusion
Keywords
Major abdominal surgery, analgesic method, Fentanyl, Remifentanyl, Postoperative cognitive disorder, Pro and anti inflammatory cytokines
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
622 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanyl
Arm Type
Experimental
Arm Description
In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.
Primary Outcome Measure Information:
Title
Rey verbal memory test of words before and after major abdominal surgery
Description
In test of Rey to the subject is presented for 5 times the same list of 15 bisyllabic words or trisillabic common use of which he must recall as many as possible within 1 minute; after about 15 minutes the patient, meanwhile distracted by the test , must again try to remember the greatest number possible without a further reading. The maximum possible score of the first phase of the test is an expression of the ability of short term memory of the subject, the result of the test is repeated at a distance of 15 minutes is indicative of its storage capacity, to intermediate term.
Time Frame
participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
Title
Stroop Test before and after surgery
Description
In the Stroop Test patient is instructed to read a random sequence of adjectives "green", "red", "blue" written in black font, then he refers the colour of a succession of circumferences filled of the three colors above in random order; finally, another random succession of three words "green", "red", "blue" written in three characters of the same colors, but not associated with corresponding adjective. Number of errors that the subject does in reading is an indication of its ability to attention
Time Frame
participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery
Description
Blood samples will be made for the quantitative determination of serum cytokines IL-1β, IL-6, IL-8, TNF-α, IL-10 and IL-12. Determinations will be given by Multiplex Elisa method.
Time Frame
participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 60 years
Patients undergoing major abdominal surgery, in General Anesthesia
ASA class status I-III
Exclusion Criteria:
History of allergy to drugs used in the study
Mini-Mental State Examination (MMSE) value < 26
Expected duration of anesthesia less than 1 hour and more than 4 hours
Presence of a cognitive disorder severity of overt such as to prevent collaboration of the patient
Presence of severe electrolyte disturbances or not controlled bool glucose levels
History of pain or cerebral vascular disease on the basis of significant carotid or cerebral artery stenosis, to be verified by scanning eco-color doppler
Habitual use of tranquillizers or other drugs affecting the central nervous system
Difficulties in the management of the airways, such as to make the necessary changes in anesthesia technique
Severe hypotension or hypertension or other vascular disorders, particularly thrombotic events or bleeding during surgery or in the perioperative period
Bleeding that requires blood transfusion
Medication needs higher or lower than that indicated in the protocol to ensure the depth of hypnosis, indicated by values of BIS targets
Refusal by the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Germano De Cosmo, Associated Professor
Organizational Affiliation
Catholic University of the Sacred Heart - Rome
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico Universitario "A.Gemelli"
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
10935000
Citation
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Results Reference
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Citation
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PubMed Identifier
10603995
Citation
Rasmussen LS. Perioperative cognitive decline: the extent of the problem. Acta Anaesthesiol Belg. 1999;50(4):199-204. No abstract available.
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PubMed Identifier
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Citation
Parikh SS, Chung F. Postoperative delirium in the elderly. Anesth Analg. 1995 Jun;80(6):1223-32. doi: 10.1097/00000539-199506000-00027.
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PubMed Identifier
9248516
Citation
Moller JT. Cerebral dysfunction after anaesthesia. Acta Anaesthesiol Scand Suppl. 1997;110:13-6. doi: 10.1111/j.1399-6576.1997.tb05484.x. No abstract available.
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Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
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