Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia

NCT03087838 | Completed DMC

• 1 other identifier: KY2017-018-02
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium may result in many adverse complications. At present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. Objective of this study is to find out incidence and risk factors of postoperative delirium in patients after elective craniotomy and also the relationship of postoperative delirium with clinical outcome.

Conditions

Intensive Care; Surgical; Postoperative Care; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

  CAM-ICU is positive

  Within the first 24 hours after operation

Study Arms (2)

delirium group

CAM-ICU is positive within the first 24 hours after operation

non-delirium group

CAM-ICU is negative within the first 24 hours after operation

Eligibility Criteria

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

Study Population

Adult Patients After Elective Craniotomy Under General Anaesthesia

You may qualify if:

• Adult patients after elective craniotomy under general anaesthesia and admitted to the ICU directly after surgery.

You may not qualify if:

• Patients younger than 18 years
• Patients with emergency operation
• Patients with preoperative impairment of consciousness (GCS\<8)
• Patients with a past medical history of delirium or schizophrenia(evaluated by the medical document)
• Patients withventriculoperitoneal shunt or endoscope operation
• Patients with inability to communicate in the preoperative period(including language barrier)
• Pregnant or lactating women.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

• Zhang X, Zhang G, Wang Y, Huang H, Li H, Li M, Yang C, Li M, Chen H, Jing B, Lin S. Alteration of default mode network: association with executive dysfunction in frontal glioma patients. J Neurosurg. 2022 Oct 14;138(6):1512-1521. doi: 10.3171/2022.8.JNS22591. Print 2023 Jun 1.

  PMID: 36242576 DERIVED

• Wang CM, Huang HW, Wang YM, He X, Sun XM, Zhou YM, Zhang GB, Gu HQ, Zhou JX. Incidence and risk factors of postoperative delirium in patients admitted to the ICU after elective intracranial surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Jan;37(1):14-24. doi: 10.1097/EJA.0000000000001074.

  PMID: 31464712 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 23, 2017
• Study Start: March 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: February 2, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)