Anesthesia Depth's Influence on Postoperative Delirium

NCT02972762 | Unknown Early Phase 1

• 1 other identifier: XiangyaH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Head Necrosis

Keywords

depth of anesthesia\postoperation delirium

Outcome Measures

Primary Outcomes (2)

• 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.

  3 days

• final data analysis

  the investigators use SPSS software to analysis data.

  10 days

Secondary Outcomes (2)

• postoperative pain score(with visual analogue scale)

  3 days

• intraoperative awareness

  1 day

Study Arms (2)

L Group

ACTIVE COMPARATOR

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

D Group

ACTIVE COMPARATOR

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

Interventions

Diprivan DRUG

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.

D Group; L Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya hospital of CSU

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Femur Head Necrosis

Interventions

Propofol

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• tao Zhong, doctor

  Xiangya hospital of CSU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 15, 2017

Record last verified: 2016-11

Locations

CN (1)