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

NCT ID: NCT04399343

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-10-01

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.

Detailed 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.

Conditions

Central Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Normal saline group

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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.

Dexmedetomidine group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine hydrochloride; 0.9% Sodium Chloride

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: STUDY_CHAIR

Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

Locations

Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jian-Xin Zhou, MD

Role: CONTACT

zhoujx.cn@gmail.com

8610 59978019

Xuan He, MD

Role: CONTACT

hexuan1204@icloud.com

Facility Contacts

Jian-Xin Zhou, MD

Role: primary

zhoujx.cn@icloud.com

86-10-59976579

References

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.

Reference Type: DERIVED

PMID: 33234648 (View on PubMed)

Other Identifiers

KY2019-091-02

Identifier Type: -

Identifier Source: org_study_id