Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery

NCT05158998 | Unknown Phase 4

• 1 other identifier: QianfoshanH PSPOD
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 2

Brief Summary

Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.

Conditions

Delirium in Old Age; Anaesthetic

Keywords

delirium; spine surgery; anaesthetic; propofol; sevoflurane

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium after surgery

  Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method.Researchers will review all progress notes and nursing documentation for delirium diagnoses, and a thorough medical record review process using the Chart-based Delirium Identification Instrument.

  Between postoperative day 1 to discharge or day 7, whichever came first

Secondary Outcomes (12)

• The day of postoperative delirium duration among patients who developed delirium

  Time from first to last delirium-positive day. Between postoperative day 1 to discharge or day 7, whichever came first

• The day of total delirium-positive days among patients who developed delirium

  Between postoperative day 1 to discharge or day 7, whichever came first

• The types of delirium in patients who developed delirium

  Between postoperative day 1 to discharge or day 7, whichever came first

• The intubation time in postanesthesia care unit (PACU)

  From the patient transfered into PACU to tracheal extubation. Within 24 hours after surgery.

• The length of stay in in postanesthesia care unit (PACU)

  Within 24 hours after surgery.

Study Arms (2)

propofol group

OTHER

For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Propofol infusion will be stopped at the end of surgery.

Drug: propofol infusion

sevoflurane group

OTHER

For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery.

Drug: sevoflurane inhalation

Interventions

propofol infusion DRUG

For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)).Propofol infusion will be stopped at the end of surgery.

propofol group

sevoflurane inhalation DRUG

For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery.

sevoflurane group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥65 years and ≤90 years;
• scheduled to undergo surgery for spinal, under general anaesthesia;
• American Society of Anesthesiology (ASA) I-III;
• agree to participate, and give signed written informed consents.

You may not qualify if:

• family history or history of malignant hyperthermia;
• History of propofol or sevoflurane allergy;
• demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, \<24of 30 or \<20 of 30 if the patient's education year was less than 6 years or\<17 if the patient is Illiterate);
• planned postoperative intubation or transferred to ICU;
• severe visual or auditory handicap;
• prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, Parkinson's disease, dementia, schizophrenia, or depressive illness)
• take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation
• participating in other clinical studies in recent 3 months

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (2)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250013, China

RECRUITING

Related Publications (1)

• Wang JH, Lv M, Zhang HX, Gao Y, Chen TT, Wan TT, Wang YL. Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. Trials. 2022 Aug 30;23(1):720. doi: 10.1186/s13063-022-06687-x.

  PMID: 36042484 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• wang yuelan, doctor

  First Affiliated Hospital of Shandong First Medical University,China.

  STUDY DIRECTOR

Central Study Contacts

wang jihua, master

CONTACT

13791125890; qy_wangjh@163.com

lv meng, doctor

CONTACT

15169105373; qylvmeng@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 15, 2021
• Study Start: March 21, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)