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=99 Participants
|
37.5 years
n=107 Participants
|
35.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Indian
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Education
uneducated(no formal education)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Education
secondary education(5th to 12th grade)
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Education
graduate (university education)
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
American society of anesthesiologists(ASA) status
ASA 1
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
American society of anesthesiologists(ASA) status
ASA 2
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
comorbidities
None
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
comorbidities
Diabetes Mellitus
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
comorbidities
Hypertension
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
comorbidities
Diabetes Mellitus and Hypertension
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Habits
None
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Habits
Alcohol
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Habits
Smoking
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Habits
Both
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
diagnosis
Fracture
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
diagnosis
Intradural extramedullary tumour
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
diagnosis
Prolapse intervertebral disc
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
diagnosis
Others
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Hemoglobin level
<12 g /dl
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Hemoglobin level
>12 g/dl
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Preoperative serum potassium level
Normal serum potassium level
|
29 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Preoperative serum potassium level
Hyperkalemia
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Preoperative serum sodium level
Hyonatremia
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Preoperative serum sodium level
Normal serum sodium level
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Preoperative serum sodium level
Hypernatremia
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Type of surgery
Laminectomy
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Type of surgery
Discectomy/Laminectomy and Discectomy
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Type of surgery
Pedicle screw fixation
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Nature of surgery
Non trauma
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Nature of surgery
Trauma
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Level of surgery
Cervical
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Level of surgery
Dorsal
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Level of surgery
Dorsolumbar
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Level of surgery
Lumbar
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Level of surgery
Lumbosacral
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Position of patient
Prone
|
26 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Position of patient
Supine
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Position of patient
Lateral
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Duration of anaesthesia
|
195 minutes
n=99 Participants
|
185 minutes
n=107 Participants
|
190 minutes
n=206 Participants
|
|
Duration of surgery
|
138 minutes
n=99 Participants
|
138 minutes
n=107 Participants
|
138 minutes
n=206 Participants
|
|
Number of episodes of intraoperative hypertension
0 episodes
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypertension
1 episode
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypertension
2 episodes
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypertension
3 episodes
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypotension
0 episodes
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypotension
1 episode
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Number of episodes of intraoperative hypotension
>1 episode
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Median emergence time
|
9.8 minutes
n=99 Participants
|
7 minutes
n=107 Participants
|
8.2 minutes
n=206 Participants
|
|
Median extubation time
|
9.5 minutes
n=99 Participants
|
9 minutes
n=107 Participants
|
9.2 minutes
n=206 Participants
|
|
Intravenous fluids transfused
|
1500 millilitres
n=99 Participants
|
1700 millilitres
n=107 Participants
|
1600 millilitres
n=206 Participants
|
|
Fentanyl dose
|
240 micrograms
n=99 Participants
|
220 micrograms
n=107 Participants
|
230 micrograms
n=206 Participants
|
|
Blood loss during surgery
|
300 millilitres
n=99 Participants
|
300 millilitres
n=107 Participants
|
300 millilitres
n=206 Participants
|
|
Number of blood units transfused
0 units
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Number of blood units transfused
1 unit
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Number of blood units transfused
2 units
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 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