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

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ClinicalTrials.gov Identifier: NCT02925611
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
steve joys, Postgraduate Institute of Medical Education and Research

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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



Primary Outcome Measures :
  1. Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925611


Locations
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India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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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)

Documents provided by steve joys, Postgraduate Institute of Medical Education and Research:

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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: October 6, 2016    Key Record Dates
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by steve joys, Postgraduate Institute of Medical Education and Research:
Postoperative delirium
spine surgery
isoflurane
desflurane
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Desflurane
Isoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs