Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction

The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Sufentanyl; Drug: Saline

Detailed Description

1. collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 300 elder patients (age ≥60 years) routine tumor surgery, American Society of Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.
2. Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3 ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program.
3. Our primary outcome was the 7-day incidence of postoperative delirium assessed by CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and nursing records. The assessment was carried out by investigators who had been trained prior to the trial and were unaware of the group assignment.All investigators and patients were unknown of experiments and results. The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4. RASS was used to measure sedation or agita-tion prior to testing delirium. If the patient was deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients' age ≥60 years
• Underwent elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

• Patients with severe bradycardia (heart rate<55bpm)
• Severe arrhythmia or cardiac dysfunction (ejection fraction<35%)
• Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
• Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
• History of alcohol abuse or a history of drug dependence
• Have brain surgery or trauma
• Severe vision or hearing impairment
• Cannot with the completion of tests of cognitive function
• Refused to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine+routine PCIA; PCIA pump was provided after surgery, which consisted of 3 ug/kg sufentanil and 3 ug/kg dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.	Drug: Dexmedetomidine; Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.; Other Names: Dexmedetomidine Hydrochloride Injection; Drug: Sufentanyl; Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.; Other Names: Sufentanil Citrate Injection; Drug: Saline; Saline is used to dilute other drugs; Other Names: normal saline,physiological saline,NS
Sham Comparator: Routine PCIA; 3 ug/kg sufentanil without dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.	Drug: Sufentanyl; Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.; Other Names: Sufentanil Citrate Injection; Drug: Saline; Saline is used to dilute other drugs; Other Names: normal saline,physiological saline,NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4.	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	including hypotension, hypertension, bradycardia, tachycardia, hypoxemia, and in-terventions (adjustment or stop study drug infusion or intravenous administration).	3 days after surgery
NRS for pain	Pain was assessed by NRS (Numeric Rating Scale) : assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	3 days after surgery

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Sufentanil; Dsuvia
• Other Study ID Numbers: 2015-01-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO