NCT02925611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

August 27, 2016

Results QC Date

April 1, 2018

Last Update Submit

March 19, 2019

Conditions

Postoperative Delirium

Keywords

Postoperative deliriumspine surgeryisofluranedesflurane

Outcome Measures

Primary Outcomes (2)

  • 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.

    24 hours post 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.

    72 hours post surgery

Secondary Outcomes (4)

  • Post Operative Pain Scores With Isoflurane and Desflurane

    24 hours post surgery

  • Post Operative Pain Scores With Isoflurane and Desflurane

    72 hours post surgery

  • CAM-S Delirium Severity Score With Isoflurane and Desflurane

    24 hours post surgery

  • CAM-S Delirium Severity Score With Isoflurane and Desflurane

    72 hours post surgery

Study Arms (2)

Isoflurane

ACTIVE COMPARATOR

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

Drug: Isoflurane

Desflurane

ACTIVE COMPARATOR

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

Drug: Desflurane

Interventions

IsofluraneDRUG
Isoflurane
DesfluraneDRUG
Desflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cardiorespiratory disorders
  • Associated cerebral disease
  • Psychiatric illness
  • Electrolyte and hormonal imbalance
  • History of drug abuse
  • Postoperative meningitis
  • Administration of high dose steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

IsofluraneDesflurane

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsEthyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Limitations and Caveats

1. Small sample size 2. Postoperative delirium was assessed only up to to 72 hours post surgery. POD can persist for months following surgery.

Results Point of Contact

Title
Dr. Steve Joys
Organization
PGIMER
stevejoys@gmail.com
7087617352

Study Officials

  • Steve Joys, MBBS

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

  • Hemant Bhagat, DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 27, 2016

First Posted

October 6, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)