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The comparison of two drug combination versus three drug combination for spinal anesthesia for below umbilical surgeries

A randomized controlled double-blinded study to compare bupivacaine with dexmedetomidine versus bupivacaine with fentanyl and dexmedetomidine in spinal anaesthesia for below-umbilical surgeries - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087790
Enrollment
76
Registered
2025-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Injection Bupivacaine 0.5% Heavy with Injection Fentanyl 25 mcg and Injection Dexmedetomidine 5 mcg: This is the double adjuvant spinal drug combination. Control Intervention1: Injectio

Sponsors

SBKS medical institute and research center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. PATIENT WILLING TO SIGN THE INFORMED WRITTEN CONSENT 2. PATIENT OF ASA GRADE 1 AND 2 OF EITHER GENDER 3. UNDER SPINAL ANAESTHESIA FOR ELECTIVE PELVIC AND LOWER LIMB SURGERIES 4. AGED 20-60 YEARS 5. NO KNOWN HISTORY OF ALLERGY, SENSITIVITY TO LOCAL ANAESTHETICS OF THE AMIDE GROUP AND OTHER DRUGS USED FOR THIS STUDY

Exclusion criteria

Exclusion criteria: 1.Patient refusal 2.Patient not nil by mouth 3.History of seizure disorder 4.Known allergy to trial drugs 5.Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junctions 6.Patients of asa grade 3, 4 and 5 7.Pregnant females 8.Failed spinal anaesthesia converted to general anaesthesia 9.Any contraindication to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To compare the clinical efficacy of bupivacaine with dexmedetomidine versus bupivacaine with fentanyl and dexmedetomidine in spinal anaesthesia for below-umbilical surgeries.Timepoint: 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 195 minutes, 210 minutes, 235 minutes, 250 minutes, 265 minutes, 280 minutes—

Secondary

MeasureTime frame
Assessment of onset of sensory and motor blockade, highest level and durationTimepoint: At 2 minutes, 5 minutes, 10 minutes, 15 minutes then every 5 minutes for first hour then after every 30 minutes till 2 level regression of sensory blockade and complete motor reversal—

Countries

India

Contacts

Public ContactDr Arpit Shah

SBKS medical institute and research centre

drarpitshah21@gmail.com8200278150

Outcome results

None listed

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