Postoperative cognitive dysfunction in neurosurgical patients
Phase 3
- Conditions
- Health Condition 1: G938- Other specified disorders of brain
- Registration Number
- CTRI/2021/03/032264
- Lead Sponsor
- Department of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria for exposed:
1) Patients >= 18 years with GCS of 15 undergoing elective cranial surgery including those with preoperative agitation/delirium
Inclusion criteria for unexposed:
1) Patients >= 18 years with GCS of 15 undergoing elective spine surgery including those with
preoperative agitation/delirium
Exclusion Criteria
Exclusion criteria for exposed:
1. Age below 18 years
2) Patients with preoperative GCS < 15
3) patients shifted to intensive care unit or having tracheal tube in situ
Exclusion criteria for unexposed:
1. Age below 18 years
2) Patients with preoperative GCS < 15
3) patients shifted to intensive care unit or having tracheal tube in situ
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ED: Rikerâ??s Sedation-Agitation Scale (SAS) Highest value is considered for data analysis. <br/ ><br> <br/ ><br>POD: Confusion Assessment Method (CAM) will be used to evaluate POD. <br/ ><br>Cognitive function at 3 and 6 months after recruitment to study will be assessed using Brief Screen for Cognitive Impairment (BSCI)-telephonic instrument <br/ ><br>Timepoint: ED: Rikerâ??s Sedation-Agitation Scale (SAS) Highest value is considered for data analysis. <br/ ><br> <br/ ><br>POD: Confusion Assessment Method (CAM) will be used to evaluate POD. <br/ ><br>Cognitive function at 3 and 6 months after recruitment to study will be assessed using Brief Screen for Cognitive Impairment (BSCI)-telephonic instrument <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To examine the association of ED with POD after cranial and spinal surgeries <br/ ><br>2. To identify peri-operative risk factors of ED and POD and its effect on short term and long term outcomes <br/ ><br>3) To study the effect of acute postoperative pain on ED and POD, and of persistent pain on POCDTimepoint: During the hospital stay, at 3 and 6 months post recruitment