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

NCT05168280 | Recruiting

• 1 other identifier: 2021-12-05
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dexmedetomidine; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Pain severity score

  postoperative 5 day

• The quality of recovery

  postoperative 1 day

• The quality of sleep

  postoperative 3 day

• Cognitive function

  1 day before surgery and 5 days after surgery

• Psychological health state

  1 day before surgery and postoperative 5 day

Study Arms (2)

DEX group

ACTIVE COMPARATOR

The DEX group patients will be received dexmedetomidine intraoperatively.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

The placebo group patients will be received 0.9% saline intraoperatively.

Drug: 0.9% saline

Interventions

Dexmedetomidine DRUG

The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.

DEX group

0.9% saline DRUG

The 0.9% saline is administered with the same volume at the same speed as the other group.

Placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

• Cui Q, Ma T, Liu M, Shen Z, Li S, Zeng M, Liu X, Zhang L, Peng Y. Intraoperative infusion of dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing craniotomy: a protocol of randomised clinical trial. BMJ Open. 2023 Jan 23;13(1):e063976. doi: 10.1136/bmjopen-2022-063976.

  PMID: 36690404 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 23, 2021
• Study Start: July 18, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

CN (1)