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

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Isoflurane
Desflurane
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Delirium focused on measuring Postoperative delirium, spine surgery, isoflurane, desflurane

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Isoflurane

Desflurane

Arm Description

Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.

Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
August 27, 2016
Last Updated
March 19, 2019
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02925611
Brief Title
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Official Title
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative delirium, spine surgery, isoflurane, desflurane

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isoflurane
Arm Type
Active Comparator
Arm Description
Isoflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Desflurane as an inhalational anaesthetic ,titrated with BIS ( bispectral index) /entropy monitoring,from start to end of surgery.
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Type
Drug
Intervention Name(s)
Desflurane
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Joys, MBBS
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hemant Bhagat, DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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