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

• Sponsor: Postgraduate Institute of Medical Education and Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02925611
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium	Drug: Isoflurane; Drug: Desflurane	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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).

2. Post Operative Pain Scores With Isoflurane and Desflurane [72 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).

3. 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).

4. CAM-S Delirium Severity Score With Isoflurane and Desflurane [72 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Postgraduate Institute of Medical Education and Research	Chandigarh		India	160012

Sponsors and Collaborators

• Postgraduate Institute of Medical Education and Research

Investigators

• Principal Investigator: Steve Joys, MBBS, Postgraduate Institute of Medical Education and Research
• Principal Investigator: Hemant Bhagat, DM, Postgraduate Institute of Medical Education and Research

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 31, 2015

More Information

Publications

None provided.

• Responsible Party: steve joys, Doctor, Postgraduate Institute of Medical Education and Research
• ClinicalTrials.gov Identifier: NCT02925611
• Other Study ID Numbers: 10313/PG-2Trg/2015/5408-9
• First Posted: Oct 6, 2016
• Last Update Posted: Jun 19, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by steve joys, Doctor, Postgraduate Institute of Medical Education and Research: Postoperative delirium; spine surgery; isoflurane; desflurane
• Additional relevant MeSH terms: Delirium; Desflurane; Isoflurane

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Desflurane
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Isoflurane	Desflurane	Total
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery. Desflurane	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	35.5	37.5	35.5
Sex: Female, Male (Count of Participants)
Female	7 23.3%	10 33.3%	17 28.3%
Male	23 76.7%	20 66.7%	43 71.7%
Race/Ethnicity, Customized (Count of Participants)
Indian	30 100%	30 100%	60 100%
Region of Enrollment (participants) [Number]
India	30 100%	30 100%	60 100%
Education (Count of Participants)
uneducated(no formal education)	0 0%	1 3.3%	1 1.7%
secondary education(5th to 12th grade)	21 70%	20 66.7%	41 68.3%
graduate (university education)	9 30%	9 30%	18 30%
American society of anesthesiologists(ASA) status (Count of Participants)
ASA 1	28 93.3%	26 86.7%	54 90%
ASA 2	2 6.7%	4 13.3%	6 10%
comorbidities (Count of Participants)
None	28 93.3%	26 86.7%	54 90%
Diabetes Mellitus	1 3.3%	1 3.3%	2 3.3%
Hypertension	1 3.3%	1 3.3%	2 3.3%
Diabetes Mellitus and Hypertension	0 0%	2 6.7%	2 3.3%
Habits (Count of Participants)
None	19 63.3%	23 76.7%	42 70%
Alcohol	4 13.3%	6 20%	10 16.7%
Smoking	2 6.7%	0 0%	2 3.3%
Both	5 16.7%	1 3.3%	6 10%
diagnosis (Count of Participants)
Fracture	14 46.7%	11 36.7%	25 41.7%
Intradural extramedullary tumour	7 23.3%	4 13.3%	11 18.3%
Prolapse intervertebral disc	8 26.7%	11 36.7%	19 31.7%
Others	1 3.3%	4 13.3%	5 8.3%
Hemoglobin level (Count of Participants)
<12 g /dl	14 46.7%	10 33.3%	24 40%
>12 g/dl	16 53.3%	20 66.7%	36 60%
Preoperative serum potassium level (Count of Participants)
Normal serum potassium level	29 96.7%	27 90%	56 93.3%
Hyperkalemia	1 3.3%	3 10%	4 6.7%
Preoperative serum sodium level (Count of Participants)
Hyonatremia	4 13.3%	1 3.3%	5 8.3%
Normal serum sodium level	26 86.7%	28 93.3%	54 90%
Hypernatremia	0 0%	1 3.3%	1 1.7%
Type of surgery (Count of Participants)
Laminectomy	7 23.3%	8 26.7%	15 25%
Discectomy/Laminectomy and Discectomy	7 23.3%	9 30%	16 26.7%
Pedicle screw fixation	16 53.3%	13 43.3%	29 48.3%
Nature of surgery (Count of Participants)
Non trauma	16 53.3%	19 63.3%	35 58.3%
Trauma	14 46.7%	11 36.7%	25 41.7%
Level of surgery (Count of Participants)
Cervical	4 13.3%	2 6.7%	6 10%
Dorsal	7 23.3%	6 20%	13 21.7%
Dorsolumbar	3 10%	4 13.3%	7 11.7%
Lumbar	13 43.3%	13 43.3%	26 43.3%
Lumbosacral	3 10%	5 16.7%	8 13.3%
Position of patient (Count of Participants)
Prone	26 86.7%	29 96.7%	55 91.7%
Supine	2 6.7%	1 3.3%	3 5%
Lateral	2 6.7%	0 0%	2 3.3%
Duration of anaesthesia (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	195	185	190
Duration of surgery (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	138	138	138
Number of episodes of intraoperative hypertension (Count of Participants)
0 episodes	26 86.7%	23 76.7%	49 81.7%
1 episode	2 6.7%	6 20%	8 13.3%
2 episodes	2 6.7%	0 0%	2 3.3%
3 episodes	0 0%	1 3.3%	1 1.7%
Number of episodes of intraoperative hypotension (Count of Participants)
0 episodes	21 70%	22 73.3%	43 71.7%
1 episode	6 20%	4 13.3%	10 16.7%
>1 episode	3 10%	4 13.3%	7 11.7%
Median emergence time (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	9.8	7	8.2
Median extubation time (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]	9.5	9	9.2
Intravenous fluids transfused (millilitres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millilitres]	1500	1700	1600
Fentanyl dose (micrograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [micrograms]	240	220	230
Blood loss during surgery (millilitres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millilitres]	300	300	300
Number of blood units transfused (Count of Participants)
0 units	27 90%	27 90%	54 90%
1 unit	3 10%	2 6.7%	5 8.3%
2 units	0 0%	1 3.3%	1 1.7%

Outcome Measures

1. Primary Outcome

Title	Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
POD +	3 10%	4 13.3%
POD -	27 90%	26 86.7%

2. Primary Outcome

Title	Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
POD +	2 6.7%	0 0%
POD -	28 93.3%	30 100%

3. Secondary Outcome

Title	Post Operative Pain Scores With Isoflurane and Desflurane
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
Median (Inter-Quartile Range) [units on a scale]	3.5	4.5

4. Secondary Outcome

Title	Post Operative Pain Scores With Isoflurane and Desflurane
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
Median (Inter-Quartile Range) [units on a scale]	1.5	2.5

5. Secondary Outcome

Title	CAM-S Delirium Severity Score With Isoflurane and Desflurane
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
Median (Inter-Quartile Range) [units on a scale]	1.5	1

6. Secondary Outcome

Title	CAM-S Delirium Severity Score With Isoflurane and Desflurane
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isoflurane	Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane	Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
Measure Participants	30	30
Median (Inter-Quartile Range) [units on a scale]	0.5	0.5

Adverse Events

Time Frame	18 months
Arm/Group Title	Isoflurane		Desflurane
Arm/Group Description	Isoflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Isoflurane		Desflurane as an inhalational anaesthetic ,titrated with entropy monitoring,from start to end of surgery. Desflurane
All Cause Mortality
	Isoflurane		Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Isoflurane		Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Isoflurane		Desflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

Small sample size Postoperative delirium was assessed only up to to 72 hours post surgery. POD can persist for months following surgery.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.