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Comparison of butorphanol and dexmedetomidine added to spinal ropivacaine for pain relief during lower body surgery

Comparative Evaluation of Intrathecal Butorphanol and Dexmedetomidine as an Adjuvant to Hyperbaric Ropivacaine in Subarachnoid Block. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091178
Enrollment
75
Registered
2025-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Ropivacaine with Butorphanol or Dexmedetomidine: Group RB: Intrathecal 0.75% hyperbaric ropivacaine 3.5 ml + butorphanol 100 mcg (0.1 ml) Group RD: Intrathecal 0.75% hyperbaric ropivaca

Sponsors

School of Medical Sciences and Research and Sharda Hospital Greater Noida
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients scheduled for infraumbilical surgery under subarachnoid block. ASA Physical Status Grade I and II. Age between 18 to 60 years. Both male and female patients.

Exclusion criteria

Exclusion criteria: Morbid obesity Patient with history of adverse response to study drugs Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease Contraindications for spinal anaesthesia like: Raised ICP, local site infections & spinal deformities like kyphosis and scoliosis Pregnant females Coagulopathy or bleeding diathesis

Design outcomes

Primary

MeasureTime frame
Time of onset of sensory and motor blockade (assessed using pinprick method and Modified Bromage scale respectively)Timepoint: Every 1 minute until complete onset, then monitored intraoperatively

Secondary

MeasureTime frame
To compare the duration of sensory and motor blockade assessed by pin prick, Visual Analog Score (VAS) and modified Bromage scale respectively. Changes in vitals parameters-heart rate (HR), noninvasive blood pressure (NIBP), and oxygen saturation (SPO2) intra operatively. Requirement of first rescue analgesic in postoperative period in the first 24 hours.Timepoint: Assessed every 1 min until onset, then every 10 min post 2 hours until full recovery Baseline, then every 5 minutes intraoperatively and every 15 minutes post-op for 3 hours Monitored continuously up to 24 hours post-op

Countries

India

Contacts

Public ContactDr Apurva Tandon

School of Medical Sciences and Research Sharda University

manish.agarwal@sharda.ac.in9838706199

Outcome results

None listed

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