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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoflurane | Active Comparator | Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. |
|
| Desflurane | Active Comparator | Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoflurane | Drug |
| ||
| Desflurane |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Joys, MBBS | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Hemant Bhagat, DM | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Chandigarh | 160012 | India |
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60 patients were enrolled in the study and underwent randomisation to receive isolfurane or desflurane anaesthesia with 30 patients in each group.No patients were lost to follow up and all patients were analysed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Isoflurane | Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Isoflurane |
| FG001 | Desflurane | Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Desflurane |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Isoflurane | Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Isoflurane |
| BG001 | Desflurane | Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Desflurane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 24 hours post surgery |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isoflurane | Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steve Joys | PGIMER | 7087617352 | 91 | stevejoys@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 31, 2015 | Apr 1, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007530 | Isoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D005019 | Ethyl Ethers |
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|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| American society of anesthesiologists(ASA) status | ASA 1- A normal, healthy patient ASA 2- Mild systemic disease.eg- smoker,social alcohol drinker, controlled diabetes mellitus /hypertension. | Count of Participants | Participants |
|
| comorbidities | Count of Participants | Participants |
|
| Habits | Count of Participants | Participants |
|
| diagnosis | Count of Participants | Participants |
|
| Hemoglobin level | Count of Participants | Participants |
|
| Preoperative serum potassium level | Count of Participants | Participants |
|
| Preoperative serum sodium level | Count of Participants | Participants |
|
| Type of surgery | Count of Participants | Participants |
|
| Nature of surgery | Count of Participants | Participants |
|
| Level of surgery | Count of Participants | Participants |
|
| Position of patient | Count of Participants | Participants |
|
| Duration of anaesthesia | Median | Inter-Quartile Range | minutes |
|
| Duration of surgery | Median | Inter-Quartile Range | minutes |
|
| Number of episodes of intraoperative hypertension | Count of Participants | Participants |
|
| Number of episodes of intraoperative hypotension | Count of Participants | Participants |
|
| Median emergence time | Median | Inter-Quartile Range | minutes |
|
| Median extubation time | Median | Inter-Quartile Range | minutes |
|
| Intravenous fluids transfused | Median | Inter-Quartile Range | millilitres |
|
| Fentanyl dose | Median | Inter-Quartile Range | micrograms |
|
| Blood loss during surgery | Median | Inter-Quartile Range | millilitres |
|
| Number of blood units transfused | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 72 hours post surgery |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours post surgery |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 72 hours post surgery |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours post surgery |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 72 hours post surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Desflurane | Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane | 0 | 30 | 0 | 30 | 0 | 30 |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |