Lumbar Plexus-sciatic Nerve Block With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty

NCT03162861 | Unknown DMC

• 1 other identifier: QinghaiUH_007
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination

  To assess cognitive function. Mini-Mental State Examination (MMSE) items include memory, attention and computing ability, orientation, recall ability and language skill. Score range: 0-30. MMSE score \< 25 is considered as cognitive dysfunction. All of the above tests will be performed by the same professional attending physician in patients with mental emotional stability.

  Change from Baseline Mini-Mental State Examination at 3 day

Secondary Outcomes (1)

• Montreal Cognitive Assessment

  day 1 and day 3 after surgery

Study Arms (2)

the observation group

EXPERIMENTAL

The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance.

Drug: sevoflurane inhalation for anesthesia

the control group

EXPERIMENTAL

The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance.

Drug: propofol for anesthesia

Interventions

sevoflurane inhalation for anesthesia DRUG

The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance.

Also known as: sevoflurane group

the observation group

propofol for anesthesia DRUG

The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance.

Also known as: propofol group

the control group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 60-70 years
• American Society of Anesthesiologists (ASA) classification: Class II and class III
• Unilateral hip arthroplasty
• Educational level: Junior high school and above, no cognitive dysfunction before surgery
• Hip joint disease treatment for the first time
• All patients or family members signed the informed consent

You may not qualify if:

• Nervous system disease or psychosis
• Allergy to anesthesia
• Poor compliance
• Cardiovascular system disease, severe primary liver and kidney diseases
• Other diseases affecting cognitive function or cognitive dysfunction

Sponsors & Collaborators

• Qinghai University: lead

MeSH Terms

Interventions

Anesthesia; Propofol

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yanhong Guo, Ph.D

  Affiliated Hospital, Qinghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 22, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 22, 2017

Record last verified: 2017-05