Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176696
Status:
TERMINATED
Last Update Posted:
2016-10-06
First Post:
2005-09-13
Brief Title:
Biobehavioral Recovery From Surgery and Anesthesia
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Detection of Nociception Pain During General Anesthesia
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator has left the UMDNJ
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reducing postoperative pain leads to increased patient comfort and facilitates speedy recovery and discharge from the hospital following surgery The focus of controlling postoperative pain has gradually shifted from postoperative management to intraoperative management The investigators believe that this study is a unique opportunity to assess the adequacy of intraoperative analgesia allowing for immediate administration of the appropriate opioid analgesics The purpose of this research is to bring to light the applicability of facial electromyography as an intraoperative solution to postoperative pain management
Detailed Description:
After consenting to enter the study the subject will be asked a series of questions regarding hisher medical history Heshe will be shown the test for determining consciousness by squeezing the experimenters hand when asked It will be explained to himher that once unconscious heshe will not be able to respond to the command of squeezing the hand The facial monitor will be shown to the patient as well as its location of placement
Intraoperative Period The leads will be placed for the FACE monitor as well as for the BIS monitoring device The objective of the BIS monitor which is already in use in the University Hospital Operating room suites is to determine consciousness An identical and typical anesthetic protocol will be utilized for all the patients in order to eliminate anesthetic factors The protocol is as follows
After administration of propofol for induction a forearm tourniquet device will be inflated to a pressure greater than 200 mm Hg A muscle relaxant will then be given once the tourniquet is inflated while the arm with the tourniquet will not be paralyzed This allows for a check on the unconsciousness of the patient that is the patient will be told squeeze my hand It is expected that no patient will respond by squeezing his or her hand because they are unconscious and anesthetized The maximum length of time the cuff will be inflated is 20 minutes Tourniquets applied to the entire leg or arm are normally inflated for up to 120 minutes and are standard practice in orthopedic surgery
One group of patients determined randomly will be administered 250 ug of fentanyl during induction of anesthesia while the second group also determined randomly will be administered 50 ug of fentanyl Both groups of patients will be administered an inhalational anesthetic isoflurane desflurane or sevoflurane at the level 30 above that which insures unconsciousness called 11 MAC but will not be given nitrous oxide during the 10 minutes of our study period due to this gas effect on Hagihiras loss of bicoherence phenomenon
The study period will begin 5 minutes before surgical incision and will end 5 minutes after surgical incision Our hypothesis is that central registration of pain exists despite the presence of adequate unconsciousness in the patient and FACE technology will complement the use of the BIS EEG monitor to ensure effective administration of anesthesia for patients in the future
Intraoperative Period The leads will be placed for the FACE monitor as well as for the BIS monitoring device The objective of the BIS monitor which is already in use in the University Hospital Operating room suites is to determine consciousness An identical and typical anesthetic protocol will be utilized for all the patients in order to eliminate anesthetic factors The protocol is as follows
After administration of propofol for induction a forearm tourniquet device will be inflated to a pressure greater than 200 mm Hg A muscle relaxant will then be given once the tourniquet is inflated while the arm with the tourniquet will not be paralyzed This allows for a check on the unconsciousness of the patient that is the patient will be told squeeze my hand It is expected that no patient will respond by squeezing his or her hand because they are unconscious and anesthetized The maximum length of time the cuff will be inflated is 20 minutes Tourniquets applied to the entire leg or arm are normally inflated for up to 120 minutes and are standard practice in orthopedic surgery
One group of patients determined randomly will be administered 250 ug of fentanyl during induction of anesthesia while the second group also determined randomly will be administered 50 ug of fentanyl Both groups of patients will be administered an inhalational anesthetic isoflurane desflurane or sevoflurane at the level 30 above that which insures unconsciousness called 11 MAC but will not be given nitrous oxide during the 10 minutes of our study period due to this gas effect on Hagihiras loss of bicoherence phenomenon
The study period will begin 5 minutes before surgical incision and will end 5 minutes after surgical incision Our hypothesis is that central registration of pain exists despite the presence of adequate unconsciousness in the patient and FACE technology will complement the use of the BIS EEG monitor to ensure effective administration of anesthesia for patients in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None