Phase 4
N=120
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03793751 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Cases Developing POCD — 10; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine Injection (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Tata Main Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cases Developing POCD |
10; 21 | — |
| SECONDARY Systolic Blood Pressure |
129.07; 125.4; 130.78; 125.45; 128.22; 127.48 | — |
| SECONDARY Diastolic Blood Pressure |
79.48; 80.40; 78.92; 78.15; 78.53; 80.17 | — |
| SECONDARY Heart Rate |
75.00; 81.90; 74.80; 82.02; 79.8; 82.02 | — |
| SECONDARY Any Adverse Outcome |
0; 0 | — |
Summary
This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.
Eligibility Criteria
Inclusion Criteria
- American society of Anesthesiology (ASA) status of I-III
- Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia
Exclusion Criteria
- Patient not willing to be a part of the study
- Patients were aged 75 years
- Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
- Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
- Patients who had recently received a sedative or opioid drug
- Patients with a MoCA (Montreal Cognitive Assessment) score <26
- Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study
Data sourced from ClinicalTrials.gov (NCT03793751). 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.