Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor

NCT04399343 | Unknown Phase 4 DMC

• 1 other identifier: KY2019-091-02
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium is common after major surgery, and is associated with adverse outcomes. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium. In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.

Conditions

Central Nervous System Diseases

Keywords

dexmedetomidine; delirium; postoperative; intracranial operation; prevention

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  Postoperative delirium is defined as delirium within 5 postoperative days, which is diagnosed by the Confusion Assessment Method for the ICU (CAM-ICU) evaluated twice daily (8:00-10:00 AM, and 18:00-20:00 PM).

  From postoperative day 1 to day 5

Secondary Outcomes (5)

• The incidence of adverse events

  From the start of study agent infusion to postoperative day 1

• The incidence of non-delirium complications

  From the start of study agent infusion to postoperative day 28

• Length of stay in the ICU

  From the start of study agent infusion to postoperative day 28

• Length of stay in hospital

  From the start of study agent infusion to postoperative day 28

• The incidence of all-caused deaths after the operation

  From the start of study agent infusion to postoperative day 28

Other Outcomes (3)

• The number of patients with the use of sedatives and analgesics

  From the start of study agent infusion to postoperative day 1

• Pain intensity

  From the start of study agent infusion to postoperative day 1

• Subjective sleep quality

  From the start of study agent infusion to postoperative day 1

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.

Drug: Dexmedetomidine

Normal saline group

PLACEBO COMPARATOR

Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.

Also known as: Dexmedetomidine hydrochloride

Dexmedetomidine group

Normal saline DRUG

Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.

Also known as: 0.9% Sodium Chloride

Normal saline group

Eligibility Criteria

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

You may not qualify if:

• Admitted to the ICU after 22:00 PM;
• Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
• Medical records documented inability to communicate in the preoperative period due to coma or language barrier;
• History of drug abuse of psychoactive and anesthetic drugs;
• Known preoperative severe sinus bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%;
• Serious hepatic dysfunction (Child-Pugh class C);
• Severe renal dysfunction requiring renal replacement therapy before the surgery;
• Allergies to ingredients or components of 5-\[(1S)-1-(2,3-dimethylphenyl)ethyl\]-1H-imidazole (dexmedetomidine hydrochloride);
• American Society of Anesthesiologists (ASA) classification of IV to VI;
• Moribund condition with low likelihood of survival for more than 24 hours;
• Pregnancy or lactation women;
• Current enrolment in another clinical trial;
• Refuse to participate.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• He X, Cheng KM, Zhang L, Gu H, Qu X, Xu Y, Ma P, Zhou JX. Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial. BMJ Open. 2020 Nov 23;10(11):e040939. doi: 10.1136/bmjopen-2020-040939.

  PMID: 33234648 DERIVED

MeSH Terms

Conditions

Central Nervous System Diseases; Delirium

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Nervous System Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, 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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jian-Xin Zhou, MD

  Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 59978019; zhoujx.cn@gmail.com

Xuan He, MD

CONTACT

hexuan1204@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: March 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)