Comparing the effects of adding two different medicines (dexmedetomidine and fentanyl) to a spinal anesthetic (bupivacaine) for surgeries on the lower legs.

Comparative addition of dexmedetomidine and fentanyl to intrathecal bupivacaine in orthopaedic procedure in lower limbs - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072638

Enrollment

153

Registered

2024-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: T07- Unspecified multiple injuries

Interventions

Intervention1: intrathecal dexmedetomidine and fentanyl: Either Group II or Group III Group II: BD Group [3mL of 0.5% hyperbaric bupivacaine plus 5 µg dexmedetomidine (diluted in 0.5ml of normal sal

Eligibility

Inclusion criteria

Inclusion criteria: In this randomized double-blinded clinical trial, patients between 18 and 55 years old, American Society of Anesthesiologist (ASA) grade I and II of either gender undergoing elective lower limb surgeries are to be selected.

Exclusion criteria

Exclusion criteria: ASA more than grade II Patients. Poorly controlled Diabetes mellitus, neuromuscular, hepatic, adrenal gland abnormality or major renal disease. Known allergy to amide local anesthetics, dexmedetomidine or fentanyl. Patients using steroids, alpha-2 receptor antagonists and calcium channel blocker Contraindication to spinal anesthesia (e.g. patient refusal, coagulation disorder, infection at the puncture site and tight valvular heart lesion)

Design outcomes

Primary

Measure	Time frame
Improvement in terms of Block (Motor + Sensory) strength and time by adding two different medicines (dexmedetomidine and fentanyl) to a spinal anesthetic (bupivacaine) for surgeries on the lower legs.Timepoint: at baseline, at 1 hr, 2 hr, 3 hr	—

Secondary

Measure	Time frame
1. To compare the haemodynamics between two groups 2. To compare post-operative pain by VAS score 3. To compare post-operative sedation score 4. To analyse complications, if any on adding these adjuncts.Timepoint: 24 hrs	—

Countries

India

Contacts

Public ContactDr Shiv Kumar Singh

Sharda University School of Medical Sciences and Research

shiv.singh@sharda.ac.in9650943359

Outcome results

None listed

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