Postoperative Delirium
Conditions
Keywords
Postoperative delirium, spine surgery, isoflurane, desflurane
Brief summary
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
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.
Interventions
DRUGIsoflurane
DRUGDesflurane
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | 24 hours post 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. |
| Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | 72 hours post 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Scores With Isoflurane and Desflurane | 24 hours post surgery | 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). |
| CAM-S Delirium Severity Score With Isoflurane and Desflurane | 24 hours post surgery | 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). |
Countries
India
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Isoflurane Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Isoflurane | 30 |
| Desflurane Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Desflurane | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Isoflurane | Total | Desflurane |
|---|---|---|---|
| Age, Continuous | 35.5 years | 35.5 years | 37.5 years |
| American society of anesthesiologists(ASA) status ASA 1 | 28 Participants | 54 Participants | 26 Participants |
| American society of anesthesiologists(ASA) status ASA 2 | 2 Participants | 6 Participants | 4 Participants |
| Blood loss during surgery | 300 millilitres | 300 millilitres | 300 millilitres |
| comorbidities Diabetes Mellitus | 1 Participants | 2 Participants | 1 Participants |
| comorbidities Diabetes Mellitus and Hypertension | 0 Participants | 2 Participants | 2 Participants |
| comorbidities Hypertension | 1 Participants | 2 Participants | 1 Participants |
| comorbidities None | 28 Participants | 54 Participants | 26 Participants |
| diagnosis Fracture | 14 Participants | 25 Participants | 11 Participants |
| diagnosis Intradural extramedullary tumour | 7 Participants | 11 Participants | 4 Participants |
| diagnosis Others | 1 Participants | 5 Participants | 4 Participants |
| diagnosis Prolapse intervertebral disc | 8 Participants | 19 Participants | 11 Participants |
| Duration of anaesthesia | 195 minutes | 190 minutes | 185 minutes |
| Duration of surgery | 138 minutes | 138 minutes | 138 minutes |
| Education graduate (university education) | 9 Participants | 18 Participants | 9 Participants |
| Education secondary education(5th to 12th grade) | 21 Participants | 41 Participants | 20 Participants |
| Education uneducated(no formal education) | 0 Participants | 1 Participants | 1 Participants |
| Fentanyl dose | 240 micrograms | 230 micrograms | 220 micrograms |
| Habits Alcohol | 4 Participants | 10 Participants | 6 Participants |
| Habits Both | 5 Participants | 6 Participants | 1 Participants |
| Habits None | 19 Participants | 42 Participants | 23 Participants |
| Habits Smoking | 2 Participants | 2 Participants | 0 Participants |
| Hemoglobin level <12 g /dl | 14 Participants | 24 Participants | 10 Participants |
| Hemoglobin level >12 g/dl | 16 Participants | 36 Participants | 20 Participants |
| Intravenous fluids transfused | 1500 millilitres | 1600 millilitres | 1700 millilitres |
| Level of surgery Cervical | 4 Participants | 6 Participants | 2 Participants |
| Level of surgery Dorsal | 7 Participants | 13 Participants | 6 Participants |
| Level of surgery Dorsolumbar | 3 Participants | 7 Participants | 4 Participants |
| Level of surgery Lumbar | 13 Participants | 26 Participants | 13 Participants |
| Level of surgery Lumbosacral | 3 Participants | 8 Participants | 5 Participants |
| Median emergence time | 9.8 minutes | 8.2 minutes | 7 minutes |
| Median extubation time | 9.5 minutes | 9.2 minutes | 9 minutes |
| Nature of surgery Non trauma | 16 Participants | 35 Participants | 19 Participants |
| Nature of surgery Trauma | 14 Participants | 25 Participants | 11 Participants |
| Number of blood units transfused 0 units | 27 Participants | 54 Participants | 27 Participants |
| Number of blood units transfused 1 unit | 3 Participants | 5 Participants | 2 Participants |
| Number of blood units transfused 2 units | 0 Participants | 1 Participants | 1 Participants |
| Number of episodes of intraoperative hypertension 0 episodes | 26 Participants | 49 Participants | 23 Participants |
| Number of episodes of intraoperative hypertension 1 episode | 2 Participants | 8 Participants | 6 Participants |
| Number of episodes of intraoperative hypertension 2 episodes | 2 Participants | 2 Participants | 0 Participants |
| Number of episodes of intraoperative hypertension 3 episodes | 0 Participants | 1 Participants | 1 Participants |
| Number of episodes of intraoperative hypotension 0 episodes | 21 Participants | 43 Participants | 22 Participants |
| Number of episodes of intraoperative hypotension >1 episode | 3 Participants | 7 Participants | 4 Participants |
| Number of episodes of intraoperative hypotension 1 episode | 6 Participants | 10 Participants | 4 Participants |
| Position of patient Lateral | 2 Participants | 2 Participants | 0 Participants |
| Position of patient Prone | 26 Participants | 55 Participants | 29 Participants |
| Position of patient Supine | 2 Participants | 3 Participants | 1 Participants |
| Preoperative serum potassium level Hyperkalemia | 1 Participants | 4 Participants | 3 Participants |
| Preoperative serum potassium level Normal serum potassium level | 29 Participants | 56 Participants | 27 Participants |
| Preoperative serum sodium level Hyonatremia | 4 Participants | 5 Participants | 1 Participants |
| Preoperative serum sodium level Hypernatremia | 0 Participants | 1 Participants | 1 Participants |
| Preoperative serum sodium level Normal serum sodium level | 26 Participants | 54 Participants | 28 Participants |
| Race/Ethnicity, Customized Indian | 30 Participants | 60 Participants | 30 Participants |
| Region of Enrollment India | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 23 Participants | 43 Participants | 20 Participants |
| Type of surgery Discectomy/Laminectomy and Discectomy | 7 Participants | 16 Participants | 9 Participants |
| Type of surgery Laminectomy | 7 Participants | 15 Participants | 8 Participants |
| Type of surgery Pedicle screw fixation | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 24 hours post surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isoflurane | Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD + | 3 Participants |
| Isoflurane | Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD - | 27 Participants |
| Desflurane | Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD + | 4 Participants |
| Desflurane | Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD - | 26 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.
Time frame: 72 hours post surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Isoflurane | Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD + | 2 Participants |
| Isoflurane | Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD - | 28 Participants |
| Desflurane | Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD + | 0 Participants |
| Desflurane | Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery | POD - | 30 Participants |
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).
Time frame: 24 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Isoflurane | CAM-S Delirium Severity Score With Isoflurane and Desflurane | 1.5 units on a scale |
| Desflurane | CAM-S Delirium Severity Score With Isoflurane and Desflurane | 1 units on a scale |
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).
Time frame: 72 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Isoflurane | CAM-S Delirium Severity Score With Isoflurane and Desflurane | 0.5 units on a scale |
| Desflurane | CAM-S Delirium Severity Score With Isoflurane and Desflurane | 0.5 units on a scale |
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).
Time frame: 24 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Isoflurane | Post Operative Pain Scores With Isoflurane and Desflurane | 3.5 units on a scale |
| Desflurane | Post Operative Pain Scores With Isoflurane and Desflurane | 4.5 units on a scale |
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).
Time frame: 72 hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Isoflurane | Post Operative Pain Scores With Isoflurane and Desflurane | 1.5 units on a scale |
| Desflurane | Post Operative Pain Scores With Isoflurane and Desflurane | 2.5 units on a scale |