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

NCT ID: NCT02925611

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Isoflurane

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

Group Type: ACTIVE_COMPARATOR

Isoflurane

Intervention Type: DRUG

Desflurane

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

Group Type: ACTIVE_COMPARATOR

Desflurane

Intervention Type: DRUG

Interventions

Isoflurane

Intervention Type: DRUG

Desflurane

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

steve joys

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steve Joys, MBBS

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Hemant Bhagat, DM

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Countries

India

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

10313/PG-2Trg/2015/5408-9

Identifier Type: -

Identifier Source: org_study_id