Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

NCT04674241 | Completed

• 1 other identifier: ChiECRCT20200436
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

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 (4)

• Pain score

  within 5 days after surgery

• Sleep quality

  within 3 days after surgery

• Quality of recovery from surgery

  1 day after surgery

• Intraoperative cardiovascular event.

  From the study drug infusion to the end of surgery.

Study Arms (2)

DEX group

ACTIVE COMPARATOR

The DEX group will receives dexmedetomidine intraoperative.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

The placebo group will receives 0.9% saline intraoperative.

Drug: 0.9% saline

Interventions

Dexmedetomidine DRUG

Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.

DEX group

0.9% saline DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing selective frontotemporal tumor resection.
• Age ≥18 years.
• Obtain written informed consent.

You may not qualify if:

• Refusal to provide written informed consent.
• Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
• Allergic to the study drug.
• History of psychotropic drugs within past 30 days.
• Pregnant or lactating women.
• 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 hepatic or renal dysfunction.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Beijing TianTan Hospital,Capital Medical University

Beijing, Beijing,China, 100070, China

Location

PLA General Hospital

Beijing, 100853, China

Location

Related Publications (4)

• Wu Y, Ren Y, Li S, Zeng M, Wang J, Li M, Peng Y. Association between intraoperative hypotension during brain tumor resection and postoperative delirium: A secondary analysis of a randomized controlled trial. PLoS One. 2025 Oct 29;20(10):e0334094. doi: 10.1371/journal.pone.0334094. eCollection 2025.

  PMID: 41160633 DERIVED

• Zeng M, Xu X, Li R, Zhang X, Ma T, Cui Q, Wang J, Li S, Peng Y. Dexmedetomidine Prevents Chronic Incisional Pain After Brain Tumor Resection: A Secondary Analysis of the Randomized Control Trial. Anesth Analg. 2024 Apr 1;138(4):839-847. doi: 10.1213/ANE.0000000000006563. Epub 2023 Jun 12.

  PMID: 37307232 DERIVED

• Li S, Li R, Li M, Cui Q, Zhang X, Ma T, Wang D, Zeng M, Li H, Bao Z, Peng Y, Sessler DI. Dexmedetomidine administration during brain tumour resection for prevention of postoperative delirium: a randomised trial. Br J Anaesth. 2023 Feb;130(2):e307-e316. doi: 10.1016/j.bja.2022.10.041. Epub 2022 Dec 13.

  PMID: 36517290 DERIVED

• Wang D, Li R, Li S, Wang J, Zeng M, Dong J, Liu X, Lin N, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial. BMJ Open. 2021 Nov 10;11(11):e051584. doi: 10.1136/bmjopen-2021-051584.

  PMID: 34758995 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

• Yu Ming Peng, MD,Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

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 Anethesiology

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 19, 2020
• Study Start: January 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 28, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (2)