Trial Outcomes & Findings for Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery (NCT NCT02925611)
NCT ID: NCT02925611
Last Updated: 2019-06-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
24 hours post surgery
Results posted on
2019-06-19
Participant Flow
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.
Participant milestones
| Measure |
Isoflurane
Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Baseline characteristics by cohort
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Desflurane
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
n=5 Participants
|
37.5 years
n=7 Participants
|
35.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Education
uneducated(no formal education)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
secondary education(5th to 12th grade)
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education
graduate (university education)
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
American society of anesthesiologists(ASA) status
ASA 1
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
American society of anesthesiologists(ASA) status
ASA 2
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
comorbidities
None
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
comorbidities
Diabetes Mellitus
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
comorbidities
Hypertension
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
comorbidities
Diabetes Mellitus and Hypertension
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Habits
None
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Habits
Alcohol
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Habits
Smoking
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Habits
Both
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
diagnosis
Fracture
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
diagnosis
Intradural extramedullary tumour
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
diagnosis
Prolapse intervertebral disc
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
diagnosis
Others
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Hemoglobin level
<12 g /dl
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Hemoglobin level
>12 g/dl
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Preoperative serum potassium level
Normal serum potassium level
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Preoperative serum potassium level
Hyperkalemia
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Preoperative serum sodium level
Hyonatremia
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Preoperative serum sodium level
Normal serum sodium level
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Preoperative serum sodium level
Hypernatremia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Type of surgery
Laminectomy
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Type of surgery
Discectomy/Laminectomy and Discectomy
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Type of surgery
Pedicle screw fixation
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Nature of surgery
Non trauma
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Nature of surgery
Trauma
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Level of surgery
Cervical
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Level of surgery
Dorsal
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Level of surgery
Dorsolumbar
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Level of surgery
Lumbar
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Level of surgery
Lumbosacral
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Position of patient
Prone
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Position of patient
Supine
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Position of patient
Lateral
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Duration of anaesthesia
|
195 minutes
n=5 Participants
|
185 minutes
n=7 Participants
|
190 minutes
n=5 Participants
|
|
Duration of surgery
|
138 minutes
n=5 Participants
|
138 minutes
n=7 Participants
|
138 minutes
n=5 Participants
|
|
Number of episodes of intraoperative hypertension
0 episodes
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypertension
1 episode
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypertension
2 episodes
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypertension
3 episodes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypotension
0 episodes
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypotension
1 episode
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Number of episodes of intraoperative hypotension
>1 episode
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Median emergence time
|
9.8 minutes
n=5 Participants
|
7 minutes
n=7 Participants
|
8.2 minutes
n=5 Participants
|
|
Median extubation time
|
9.5 minutes
n=5 Participants
|
9 minutes
n=7 Participants
|
9.2 minutes
n=5 Participants
|
|
Intravenous fluids transfused
|
1500 millilitres
n=5 Participants
|
1700 millilitres
n=7 Participants
|
1600 millilitres
n=5 Participants
|
|
Fentanyl dose
|
240 micrograms
n=5 Participants
|
220 micrograms
n=7 Participants
|
230 micrograms
n=5 Participants
|
|
Blood loss during surgery
|
300 millilitres
n=5 Participants
|
300 millilitres
n=7 Participants
|
300 millilitres
n=5 Participants
|
|
Number of blood units transfused
0 units
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Number of blood units transfused
1 unit
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of blood units transfused
2 units
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post surgeryNumber 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.
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
POD +
|
3 Participants
|
4 Participants
|
|
Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
POD -
|
27 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 72 hours post surgeryNumber 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.
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
POD +
|
2 Participants
|
0 Participants
|
|
Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
POD -
|
28 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 24 hours post surgeryComparison 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).
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
Post Operative Pain Scores With Isoflurane and Desflurane
|
3.5 units on a scale
Interval 1.0 to 6.25
|
4.5 units on a scale
Interval 2.0 to 7.25
|
SECONDARY outcome
Timeframe: 72 hours post surgeryComparison 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).
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
Post Operative Pain Scores With Isoflurane and Desflurane
|
1.5 units on a scale
Interval 1.0 to 5.0
|
2.5 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 24 hours post surgeryComparison 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).
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
CAM-S Delirium Severity Score With Isoflurane and Desflurane
|
1.5 units on a scale
Interval 0.75 to 4.25
|
1 units on a scale
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: 72 hours post surgeryComparison 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).
Outcome measures
| Measure |
Isoflurane
n=30 Participants
Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Isoflurane
|
Desflurane
n=30 Participants
Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery.
Desflurane
|
|---|---|---|
|
CAM-S Delirium Severity Score With Isoflurane and Desflurane
|
0.5 units on a scale
Interval 0.0 to 2.0
|
0.5 units on a scale
Interval 0.0 to 1.0
|
Adverse Events
Isoflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Desflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place