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

Central Nervous System Diseases Clinical Trial

— DEPOD  

Official title:

Dexmedetomidine for Prevention of Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04399343
• Other study ID #: KY2019-091-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2021
• Source: Capital Medical University
• Contact: Jian-Xin Zhou, MD
• Phone: 8610 59978019
• Email: zhoujx.cn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Postoperative delirium is common after major surgery, and is associated with adverse outcomes. However, patients with neurological illness are usually excluded from previous researches. Recently, limited studies have shown that the incidence of postoperative delirium in neurosurgical patients is approximately 20%, which is comparable to the results in other major surgery. Potential associations between postoperative delirium and adverse outcomes have also been found in neurosurgical patients. These results indicate that early prevention of postoperative delirium should be employed in this population.

As a highly selective α2-adrenergic receptor agonist, dexmedetomidine has been investigated as a preventive agent for postoperative delirium. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The inclusion criteria are adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.

The exclusion criteria include:

1. Admitted to the ICU after 22:00 PM;

2. Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;

3. Medical records documented inability to communicate in the preoperative period due to coma or language barrier;

4. History of drug abuse of psychoactive and anesthetic drugs;

5. 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%;

6. Serious hepatic dysfunction (Child-Pugh class C);

7. Severe renal dysfunction requiring renal replacement therapy before the surgery;

8. Allergies to ingredients or components of 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole (dexmedetomidine hydrochloride);

9. American Society of Anesthesiologists (ASA) classification of IV to VI;

10. Moribund condition with low likelihood of survival for more than 24 hours;

11. Pregnancy or lactation women;

12. Current enrolment in another clinical trial;

13. Refuse to participate.

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Delirium
• Nervous System Diseases

Intervention

Drug:
• Dexmedetomidine
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.
• Normal saline
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.

Locations

Country	Name	City	State
China	Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of patients with the use of sedatives and analgesics	Include propofol, midazolam, opioids and nonsteroidal anti-inflammatory drugs	From the start of study agent infusion to postoperative day 1
Other	Pain intensity	Assessed by the critical-care pain observation tool (CPOT) with a total score of 0-8. Higher scores mean a worsening of pain.	From the start of study agent infusion to postoperative day 1
Other	Subjective sleep quality	Assessed by numerical rating scale (NRS) with a total score of 0-10. Higher scores mean a better sleep.	From the start of study agent infusion to postoperative day 1
Primary	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	The incidence of adverse events	Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)	From the start of study agent infusion to postoperative day 1
Secondary	The incidence of non-delirium complications	Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection	From the start of study agent infusion to postoperative day 28
Secondary	Length of stay in the ICU	Time of ICU discharge	From the start of study agent infusion to postoperative day 28
Secondary	Length of stay in hospital	Time of hospital discharge	From the start of study agent infusion to postoperative day 28
Secondary	The incidence of all-caused deaths after the operation	All of the deaths that occur after the study agent infusion	From the start of study agent infusion to postoperative day 28