Effect of Intraoperative Sedation on PND in Elderly Patients

NCT04891458 | Unknown DMC

• 1 other identifier: IOSPND
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to identify the effects of different depths of sedation and choices of sedative drugs on perioperative neurocognitive disorders in the elderly patients receiving hip surgery under spinal anesthesia.

Conditions

Elderly; Anesthesia

Keywords

Anesthesia; Spinal

Outcome Measures

Primary Outcomes (2)

• postoperative delirium

  Postoperative delirium is assessed with the Confusion Assessment Method and in accordance with the the Diagnostic and Statistical Manual of Mental Disorders, 5th edition diagnostic criteria for delirium，each postoperative day until discharge. Delirium severity is scored using the long Confusion Assessment Method Severity score.

  1 week

• Change from Cognitive state in 1 week.

  Cognitive state is measured with the Beijing version of Montreal Cognitive Assessment preoperatively，on the first day and the seventh day after surgery. A score of ≥26 is considered normal in Montreal Cognitive Assessment，with the maximum score of 30 points. The lower the score, the worse the cognitive status.

  1 week

Secondary Outcomes (1)

• Inflammatory biomarker level in blood

  before anesthesia (T0), 1 hour after operation (T1), 1 day after operation (T2) and 7 days after operation (T3)

Study Arms (4)

Patients received lighter sedation with propofol after spinal anesthesia

EXPERIMENTAL

Continuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 0-2.

Drug: Patients received lighter sedation with propofol after spinal anesthesia.

Patients received heavier sedation with propofol after spinal anesthesia

EXPERIMENTAL

Continuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 3-5.

Drug: Patients received heavier sedation with propofol after spinal anesthesia

Patients received lighter sedation with dexmedetomidine after spinal anesthesia.

EXPERIMENTAL

Continuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 0-2.

Drug: Patients received lighter sedation with dexmedetomidine after spinal anesthesia

Patients received heavier sedation with dexmedetomidine after spinal anesthesia.

EXPERIMENTAL

Continuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 3-5.

Drug: Patients received heavier sedation with dexmedetomidine after spinal anesthesia.

Interventions

Patients received lighter sedation with propofol after spinal anesthesia. DRUG

MOAA/S 0-2.

Patients received lighter sedation with propofol after spinal anesthesia

Patients received heavier sedation with propofol after spinal anesthesia DRUG

MOAA/S 3-5.

Patients received heavier sedation with propofol after spinal anesthesia

Patients received lighter sedation with dexmedetomidine after spinal anesthesia DRUG

MOAA/S 0-2.

Patients received lighter sedation with dexmedetomidine after spinal anesthesia.

Patients received heavier sedation with dexmedetomidine after spinal anesthesia. DRUG

MOAA/S 3-5.

Patients received heavier sedation with dexmedetomidine after spinal anesthesia.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Acquisition of informed consent,
• Patients with hip fracture surgery under spinal anesthesia,
• Grade I to III based on American Society of Anesthesiologists ASA classification,
• Age ≥65.

You may not qualify if:

• There was a history of cardiovascular and cerebrovascular adverse events in the past six months, including myocardial infarction, angina pectoris, severe arrhythmia, stroke or transient ischemic attack (TIA)
• Heart failure (NYHA III / IV and / or LVEF \< 30%)
• Bradycardia
• Respiratory failure (need oxygen)
• Glasgow Coma Scale ≤ 14 points
• Severe hepatic and renal insufficiency (child Pugh grade B or C)
• Preoperative cognitive impairment or sedative drugs (benzodiazepines, etc.).
• Adverse reactions such as allergy to dexmedetomidine or / or propofol
• Preoperative bilateral hip fracture or other trauma need simultaneous operation
• Contraindications of spinal anesthesia

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Officials

• Shuang Zhao, PhD

  Third Hospital of Hebei Medical University Department of Anesthesiology

  STUDY CHAIR

• Shuxing Zhu, M.D

  Third Hospital of Hebei Medical University Department of Anesthesiology

  STUDY DIRECTOR

• Xiuli Wang, PhD

  Third Hospital of Hebei Medical University Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Zhao, PhD

CONTACT

13613210924; zhaoshuang810924@163.com

Shuxing Zhu, M.D

CONTACT

17600129361; 524176941@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Anesthesiologists who provide anesthesia for patients need to adjust the dose of sedative drugs according to the score of MOAA/S during operation, so blind method is not used for anesthesiologists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 18, 2021

Record last verified: 2021-05