Phase 4
N=60
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Postoperative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT02925611 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery — 3; 4; 27; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isoflurane (Drug); Desflurane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery |
3; 4; 27; 26 | — |
| PRIMARY Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery |
2; 0; 28; 30 | — |
| SECONDARY Post Operative Pain Scores With Isoflurane and Desflurane |
1.5; 2.5 | — |
| SECONDARY Post Operative Pain Scores With Isoflurane and Desflurane |
1.5; 2.5 | — |
| SECONDARY CAM-S Delirium Severity Score With Isoflurane and Desflurane |
0.5; 0.5 | — |
| SECONDARY CAM-S Delirium Severity Score With Isoflurane and Desflurane |
0.5; 0.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02925611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.