Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery

Study Overview
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Brief Summary
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Postoperative delirium (POD) is a known complication of inhalational agents used to anaesthetise patients for surgery with potential long term implications.The incidence of postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to compare the occurrence of postoperative delirium with inhalational anaesthetics namely isoflurane and desflurane in spine surgery patients.

Detailed Description
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The patient will be randomized to receive isoflurane or desflurane anaesthesia prior to surgery. All the patients involved in the study will be blinded to group allocation. Screening for preoperative cognitive dysfunction will be done using the mini-cog test which includes a three word recall test and clock drawing test.The primary outcome variable will be assessment of delirium at day one and day three following surgery. Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. Similarly the severity of postoperative delirium will be assessed on day one and day three following surgery. Severity of postoperative delirium will be assessed using the CAM-S(Confusion Assessment Method-severity)long form delirium severity score.It assesses ten features including 1) acute onset and fluctuating course,2)inattention,3)disorganized thinking , 4)altered level of consciousness, 5) disorientation, 6)memory impairment ,7)perceptual disturbances ,8)psychomotor agitation, 9)psychomotor retardation and 10) altered sleep-wake cycle. The scores range from 0 to 19. The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted. The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted. Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten. The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Official Title
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Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: Isoflurane
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for spine surgery. Age between 18-65 years American Society of Anaesthesiologists (ASA) Grade I and II patients Patients with Glasgow Coma Scale (GCS) of 15 Postoperative Aldrette score > 9 Exclusion Criteria: Cardiorespiratory disorders Associated cerebral disease Psychiatric illness Electrolyte and hormonal imbalance History of drug abuse Postoperative meningitis Administration of high dose steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isoflurane<br>Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. | Drug: Isoflurane<br> <br> |
| Active Comparator: Desflurane<br>Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. | Drug: Desflurane<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day one following surgery. | 24 hours post surgery | 
| Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day three following surgery. | 72 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Scores With Isoflurane and Desflurane | Comparison of postoperative pain scores (measured by numerical rating score) with by isoflurane and desflurane. The numerical rating score ranges from 0 to 10 (0 being no pain and 10 being maximum subjective pain). | 24 hours post surgery | 
| Post Operative Pain Scores With Isoflurane and Desflurane | Comparison of postoperative pain scores (measured by numerical rating score) with by isoflurane and desflurane. The numerical rating score ranges from 0 to 10 (0 being no pain and 10 being maximum subjective pain). | 72 hours post surgery | 
| CAM-S Delirium Severity Score With Isoflurane and Desflurane | Comparison of CAM-S delirium severity score with isoflurane and desflurane. CAM-S delirium severity score ranges from 0 to 19 ( 0 being best outcome and 19 being worst outcome). | 24 hours post surgery | 
| CAM-S Delirium Severity Score With Isoflurane and Desflurane | Comparison of CAM-S delirium severity score with isoflurane and desflurane. CAM-S delirium severity score ranges from 0 to 19 ( 0 being best outcome and 19 being worst outcome). | 72 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative delirium, spine surgery, isoflurane, desflurane