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Comparing Dexmedetomidine to a standard treatment to see if it helps reduce confusion in elderly undergoing urological surgeries under spinal anesthesia

Effect of Intravenous Sedation with Dexmedetomidine on Postoperative Delirium in Elderly undergoing Endoscopic Urological Surgeries under Spinal Anesthesia – A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075141
Enrollment
116
Registered
2024-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: N20- Calculus of kidney and ureter Health Condition 3: C67- Malignant neoplasm of bladder Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: Intravenous sedation with Dexmedetomidine infusion at 0.2-0.4mcg/kg/hour. Infusion will be started after ensuring adequate level of blockade (at least T10) and hemodyn

Sponsors

Dr Nada Fathima
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients aged 60 years or older undergoing endoscopic urological surgeries under spinal anesthesia. 2.American Society of Anesthesiologists (ASA) status 1 and 2.

Exclusion criteria

Exclusion criteria: 1.History of dementia or mini-cog less than 3. 2.History of psychiatric or neurodegenerative disorder 3.Profound hearing loss (difficulty in understanding loud speech) 4.Complete visual loss 5.Ischemic or valvular heart disease, heart failure (NYHA class 3 or 4), uncontrolled hypertension, severe pulmonary disease. 6.End Stage Renal Disease / Hepatic impairment. 7.Patients with failed spinal/high spinal

Design outcomes

Primary

MeasureTime frame
Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithmTimepoint: Postoperative period- At 24hour—

Secondary

MeasureTime frame
Number of boluses of mephentermine administeredTimepoint: Intraoperative period;Side effect profile (hypotension, bradycardia, desaturation, oversedation)Timepoint: Intraoperative and postoperative period;VAS scoreTimepoint: 2,6,12, and 24 hours in the postoperative period;Catheter-induced bladder discomfort intensity by a 3point likert scale (1-comfortable, 2-uncomfortable but bearable, 3-uncomfortable and unbearable)Timepoint: 2,6,12, and 24 hours in the postoperative period;Comparison of incidence of postoperative delirium based on Confusion Assessment Method (CAM-ICU) algorithmTimepoint: 48 and 72 hours in the postoperative period;Length of hospital stay in days after surgeryTimepoint: Date of surgery to date of discharge;Mean Arterial Pressure (MAP) and heart rateTimepoint: Intraoperative- baseline, start of infusion and every 15 minutes Postoperative for 24 hours (every 6 hours)—

Countries

India

Contacts

Public ContactDr Nada Fathima

JIPMER

gnansdr@gmail.com9487188275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026