Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia

Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia: a Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Care; Intensive Care; Neurosurgery; Surgical

Detailed Description

The study is a prospective single-center cohort study. Consecutive adult patients admitted to the ICU after elective craniotomy is enrolled. Richmond Agitation Sedation Scale (RASS) is used to assess level of consciousness of patients; if conditions met "RASS≥-3", the Confusion Assessment Method for the Intensive Care Unit will proceed to evaluate delirium signs in patients. Delirium is assessed every 12-hour shift within 3 days during the patient's ICU stay and ended when discharged from ICU or dead, time started at 9am and 9pm. On the third day after operation when most patients have been transferred to general ward, delirium was assessed only at 9am for follow-up studies. Patients is divided into two groups via assessment of CAM-ICU: delirium groups and non-delirium groups. Factors potentially related to postoperative delirium are collected and categorized as preoperative, intraoperative and postoperative in chronological order. Univariate analyses between delirium groups and non-delirium groups is performed. The stepwise backward logistic regression is carried out to identify the independent predictors of delirium. Patients will be followed up until hospital discharge, death or 90 days after the enrollment. Clinical outcome such as days on the mechanical ventilator, endotracheal extubation time, need for re-intubation and tracheotomy, unexpected reoperation within 72 h after surgery, length of stay in the ICU , hospital costs and mortality will be registered.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • ICU, Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult Patients After Elective Craniotomy Under General Anaesthesia

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	CAM-ICU is positive	Within the first 24 hours after operation

Collaborators and Investigators

• Sponsor: Capital Medical University

Publications and helpful links

General Publications

• 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 14:1-10. doi: 10.3171/2022.8.JNS22591. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: KY2017-018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No