Clinical trial NCT02925611: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Delirium
Keywords: Postoperative delirium
spine surgery
isoflurane
desflurane
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
timeFrame: 24 hours post surgery
measure: Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery
timeFrame: 72 hours post surgery
Secondary outcomes:
measure: Post Operative Pain Scores With Isoflurane and Desflurane
timeFrame: 24 hours post surgery
measure: Post Operative Pain Scores With Isoflurane and Desflurane
timeFrame: 72 hours post surgery
measure: CAM-S Delirium Severity Score With Isoflurane and Desflurane
timeFrame: 24 hours post surgery
measure: CAM-S Delirium Severity Score With Isoflurane and Desflurane
timeFrame: 72 hours post surgery
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Steve Joys, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Hemant Bhagat, DM
role: PRINCIPAL_INVESTIGATOR
References: