Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Postoperative Delirium Clinical Trial

Official title:

Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674241
• Other study ID #: ChiECRCT20200436
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: March 2022
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine
• Postoperative Delirium

Intervention

Drug:
• Dexmedetomidine
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.
• 0.9% saline
0.9% saline is administered with the same volume at the same speed as the other group.

Locations

Country	Name	City	State
China	Beijing TianTan Hospital,Capital Medical University	Beijing	Beijing,China
China	PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score	Numerical Rating Scales, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.	within 5 days after surgery
Secondary	Sleep quality	Quality of sleep was assessed by the Richards Campbell sleep questionnaire (RCSQ) and with a 0-100-mm visual analog scale, with higher scores indicating better sleep quality.	within 3 days after surgery
Secondary	Quality of recovery from surgery	Postoperative quality of recovery was assessed through the Quality of Recovery 15 item	1 day after surgery
Secondary	Intraoperative cardiovascular event.	Including: hypotension was defined as systolic blood pressure <95 mm Hg or less than 30% below baseline; hypertension was defined as systolic blood pressure > 180 mm Hg or more than 30% above baseline; bradycardia was defined by heart rate <40 bpm, and tachycardia was defined by heart rate >100 bpm.	From the study drug infusion to the end of surgery.