search
Back to results

Anesthesia Depth's Influence on Postoperative Delirium

Primary Purpose

Femur Head Necrosis

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Diprivan
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Femur Head Necrosis focused on measuring depth of anesthesia\postoperation delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya hospital of CSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

L Group

D Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

postoperative delirium score(with The Confusion Assessment Method)
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.
final data analysis
the investigators use SPSS software to analysis data.

Secondary Outcome Measures

postoperative pain score(with visual analogue scale)
intraoperative awareness

Full Information

First Posted
November 16, 2016
Last Updated
December 13, 2017
Sponsor
Xiangya Hospital of Central South University
search

1. Study Identification

Unique Protocol Identification Number
NCT02972762
Brief Title
Anesthesia Depth's Influence on Postoperative Delirium
Official Title
The Clinical Investigation of Anesthesia Depth's Influence in Total Intravenous Anesthesia on Postoperative Delirium of Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Head Necrosis
Keywords
depth of anesthesia\postoperation delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
D Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Diprivan
Intervention Description
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 Measure Information:
Title
postoperative delirium score(with The Confusion Assessment Method)
Description
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.
Time Frame
3 days
Title
final data analysis
Description
the investigators use SPSS software to analysis data.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
postoperative pain score(with visual analogue scale)
Time Frame
3 days
Title
intraoperative awareness
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participant who is selected to undergo hip replacement surgery. participant who is older than 60 years old. participant whose ASA(The American Society of Anesthesiologists) is II-III. participant whose BMI is 18-25. participant who is able to understand and complete The Confusion Assessment Method(CAM-CR). participant who is able to finish Visual Analogue Scale(VAS). participant who is conscious and willing to take part in this research. participant and his/her relatives are willing to take part in this research. Exclusion Criteria: participant who has serious liver or kidney disease. participant who suffer from mental or neurologic disease,such as Alzheimer disease. participant who has undergone cardiovascular surgery or neurosurgery. participant who has have sedation or antidepression medicine for a long time. participant who has something wrong with his/her vision or hearing. participant who has blood coagulation dysfunction. participant who is an illiteracy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tao Zhong, doctor
Organizational Affiliation
Xiangya hospital of CSU
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya hospital of CSU
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Anesthesia Depth's Influence on Postoperative Delirium

We'll reach out to this number within 24 hrs