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Anesthesia Depth's Influence on Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT02972762
Recruitment Status : Unknown
Verified November 2016 by Xiangya Hospital of Central South University.
Recruitment status was:  Enrolling by invitation
First Posted : November 23, 2016
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
The investigators,according to the eligibility criteria,plane to choose 80 elderly anticipates who will undergo selective hip replacement surgery.This participants will be randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia depth group (D Group).Before anesthesia induction,each participant will be given lumbar plexus and sciatic nerve block in order to control pain of interoperative and postoperative.During operation period,the L Group will be kept in light anesthesia depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS values in the range of 30-60 have been recommended in general anesthesia.After operation,a PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each participant to control postoperative pain. The investigator will evaluate the mental state of participant with MMSE(mini-mental state examination) before surgery and review each participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation delirium.intraoperative awareness,postoperative pain will also be investigated in postoperative days 1, 2, 3.

Condition or disease Intervention/treatment Phase
Femur Head Necrosis Drug: Diprivan Early Phase 1

Detailed Description:
The investigators,according to the eligibility criteria,plane to choose 80 elderly participants who will undergo selective hip replacement surgery.This participants will be randomly divided into 2 groups:light anesthesia depth group(BIS:50-60) and deep anesthesia depth group (BIS:35-45)--The BIS values in the range of 30-60 have been recommended in general anesthesia.Before anesthesia induction,each participant will be given lumbar plexus and sciatic nerve block in order to control pain of intraoperative and postoperative.The investigator use propofol 4ug\kg、and sufentanil 0.2ug\kg during anesthesia induction period,after that,a Laryngeal mask will be placed into patient's mouth.Anesthesia is maintained with remifentanil TCI(target-controlled infusion) target-controlled infusion(concentration:2ng/ml) and propofol BIS closed-loop target-controlled infusion.During the operation period ,the investigator keep the L Group`s BIS range from 50 to 60.While the D Group`s BIS range from 35 to 45.All participants receive postoperative analgesia.After operation,all participants will be send to PACU(post-anaesthesia care unit ) to wake up and send back to ward,And a PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each participants to control postoperative pain.The investigators will use MMSE(mini-mental state examination) to evaluate the participant's mental state before surgery.For 3 days after operation,The investigator will review each participant with a CAM-CR to assess the situation of postoperation delirium.The investigator will see if there is intraoperative awareness by asking questions.Postoperative pain(with VAS) will also be investigated in postoperative days 1, 2, 3.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Clinical Investigation of Anesthesia Depth's Influence in Total Intravenous Anesthesia on Postoperative Delirium of Elderly Patients
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: L Group
The participants in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 50 to 60.The values of BP,P,PetCO2 will be controled in proper site. each participant will be given postoperative analgesia pump to release postoperative pain.
Drug: Diprivan
anesthesia will be maintained with remifentanil and Diprivan.we use Diprivan close-loop to control the anesthesia depth,and the anesthesia depth will be detected with BIS machine.the usage of remifentanil、ropivacaine、sufentanil and cisatracurium in both arms is no difference.

Active Comparator: D Group
The participant in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 35 to 45.The values of BP,P,PetCO2 will be controled in proper site. The investigator use postoperative analgesia pump to control postoperative pain for each participant.
Drug: Diprivan
anesthesia will be maintained with remifentanil and Diprivan.we use Diprivan close-loop to control the anesthesia depth,and the anesthesia depth will be detected with BIS machine.the usage of remifentanil、ropivacaine、sufentanil and cisatracurium in both arms is no difference.




Primary Outcome Measures :
  1. postoperative delirium score(with The Confusion Assessment Method) [ Time Frame: 3 days ]
    the The Confusion Assessment Method is widely used to access the postoperative delirium all around the world.the total score more than 22 means that the The participant has got delirium.

  2. final data analysis [ Time Frame: 10 days ]
    the investigators use SPSS software to analysis data.


Secondary Outcome Measures :
  1. postoperative pain score(with visual analogue scale) [ Time Frame: 3 days ]
  2. intraoperative awareness [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. participant who is selected to undergo hip replacement surgery.
  2. participant who is older than 60 years old.
  3. participant whose ASA(The American Society of Anesthesiologists) is II-III.
  4. participant whose BMI is 18-25.
  5. participant who is able to understand and complete The Confusion Assessment Method(CAM-CR).
  6. participant who is able to finish Visual Analogue Scale(VAS).
  7. participant who is conscious and willing to take part in this research.
  8. participant and his/her relatives are willing to take part in this research.

Exclusion Criteria:

  1. participant who has serious liver or kidney disease.
  2. participant who suffer from mental or neurologic disease,such as Alzheimer disease.
  3. participant who has undergone cardiovascular surgery or neurosurgery.
  4. participant who has have sedation or antidepression medicine for a long time.
  5. participant who has something wrong with his/her vision or hearing.
  6. participant who has blood coagulation dysfunction.
  7. participant who is an illiteracy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972762


Locations
China, Hunan
Xiangya hospital of CSU
Changsha, Hunan, China, 410000
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
Study Director: tao Zhong, doctor Xiangya hospital of CSU

Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02972762     History of Changes
Other Study ID Numbers: XiangyaH
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: November 2016

Keywords provided by Xiangya Hospital of Central South University:
depth of anesthesia\postoperation delirium

Additional relevant MeSH terms:
Osteonecrosis
Delirium
Necrosis
Femur Head Necrosis
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Ropivacaine
Remifentanil
Sufentanil
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General