Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients

Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial

Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Dexmedetomidine
• Intervention / Treatment: Drug: 0.9% saline; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuming Peng, MD,Ph.D; Phone Number: 8610-59976658; Email: florapym766@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tian Tan Hospital, Capital Medical University
      • Contact: Yuming Peng; Phone Number: 8610-59976658; Email: florapym766@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing selective craniotomy.
• Age ≥65 years.
• Obtain written informed consent.

Exclusion Criteria:

• Operation time less than 2 hours.
• Refusal to provide written informed consent.
• Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
• Allergic to the study drug.
• Body mass index ≤18 or ≥ 30 kg/m2.
• History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
• History of traumatic brain injury or neurosurgery.
• Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
• Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
• The functional neurosurgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DEX group; The DEX group patients will be received dexmedetomidine intraoperatively.	Drug: Dexmedetomidine; The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.
Placebo Comparator: Placebo group; The placebo group patients will be received 0.9% saline intraoperatively.	Drug: 0.9% saline; The 0.9% saline is administered with the same volume at the same speed as the other group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative delirium	Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.	postoperative 5 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity score	The degree of surgical incision pain will be assessed at rest and on movement by Numerical Rating Scale (NRS). NRS ranges from 0 to 10, with the highest score indicating the worst pain.	postoperative 5 day
The quality of recovery	The quality of recovery will be assessed with 15-item quality of recovery questionnaire (QoR-15). The QoR-15 measures cognitive function, physical activity, language and mood on a 150-point scale, with higher scores indicating better quality of recovery.	postoperative 1 day
The quality of sleep	The quality of sleep will be assessed by the Richards Campbell sleep questionnaire (RCSQ).RCSQ is mainly used to evaluate the sleep quality of the previous night. The scale comprises five items: sleep depth, sleep latency, wake up times, relapse to sleep and overall sleep quality.The total score of the scale is the average of 5 items, and the lower the score, the better the sleep quality.	postoperative 3 day
Cognitive function	Cognitive function will be assessed 1 day before surgery and 5 days after surgery using MMSE scale and Montreal Cognitive Assessment (MoCA) scale. MMSE includes seven items: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language and visual space.A total of 30 questions will be asked, 1 point for each correct answer, 0 point for a wrong answer or unknown answer and the total score range from 0 to 30. MoCA scale was widely identified that MoCA was superior to MMSE in the detection of mild cognitive impairment. Furthermore, the MoCA showed differences in cognitive profile even in those performing in the normal range on the MMSE and would appear to be a useful brief tool to assess cognition in those with mild cognitive impairment.	1 day before surgery and 5 days after surgery
Psychological health state	Psychological health state will be assessed by Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).There are 7 and 9 items to screen anxiety and depression, respectively. The point of each item is 3. The total points >4 will be regarded as anxiety and depression.	1 day before surgery and postoperative 5 day
The intraoperative data	Intraoperative data include total dose of anesthetics, bispectral index scale value, and cardiovascular adverse events will be recorded and classified as hypotension (systolic blood pressure<95mmHg, or lower than 30% baseline), hypertension (systolic blood pressure ≥180 mmHg, or higher than 30% baseline), bradycardia (heart rate <40 beats /min), tachycardia (heart rate ≥ 100 beats /min) or hypoxemia (pulse oxygen saturation<90%).	The surgery day
Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.	Non-delirium complications include cardiac arrest, infection of the incision, sepsis, intracranial hematoma, severe intracranial edema (base on brain images), stroke, myocardial infarction, pulmonary infection and embolism.	postoperative 5 day
30-day all-cause mortality	Postoperative 30-day all-cause mortality.	postoperative 30 day
The physiological status	The physiological status of the patients will be assessed by Short-Form Mini-nutrition assessment (MNA-SF) and FRAIL scale.	1 day before surgery
Electroencephalogram changes	Electroencephalogram will be used to record the brain activity.	The surgery day
Regional cerebral oxygen saturation changes	Regional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.	The surgery day

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming Peng, MD,Ph.D, Beijing Tian tan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 2021-12-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
• IPD Sharing Time Frame: The data could be shared after 1 year after publication with the permission of principle investigator. The duration of the data sharing will be determined by principle investigator after publication.
• IPD Sharing Access Criteria: Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator. Please email principle investigator if researchers wish to have the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No