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A clinical study to examine the effects of dexmedetomidine given intravenously to patients undergoing spinal anesthesia for lower limb surgeries.

EFFECTS OF INTRAVENOUS DEXMEDETOMIDINE ON THE QUALITY OF SUBARACHNOID BLOCK WITH HYPERBARIC INTRATHECAL BUPIVACAINE FOR LOWER LIMB SURGERIES: A RANDOMIZED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035368
Enrollment
100
Registered
2021-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Intravenous Dexmedetomidine: Intravenous adjuvant to spinal anesthesia with sedative, hypnotic, analgesic, alpha-2 agonist agent. Control Intervention1: Not Applicable: Not Applicable

Sponsors

KPC Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of American Society of Anesthesiologists(ASA) Grades I and II. Patients undergoing elective lower limb surgery with spinal anesthesia.

Exclusion criteria

Exclusion criteria: Patients outside age group of 18-65 years. Patients allergic to dexmedetomidine. Patients of ASA Grades III, IV, V, VI. Significant cardiovascular, pulmonary, hepatic or renal impairment. Pregnant patients. Obese patients (BMI more than 30 kg/m2). Patients on �²-blocker and Ca2+ channel blocker. Contraindications for regional anesthesia including coagulopathy, or local skin infection. Patients preferring general anesthesia.

Design outcomes

Primary

MeasureTime frame
Onset of block including autonomic, sensory and motor block Duration of block Perioperative hemodynamic adverse effects Timepoint: Sensory blockade will be evaluated by two-dermatomal regression from the maximum level, and regression to S1 level will be noted at 1, 2, 5 min after giving spinal anesthesia and then at every 5 min till 30 min and then at every 15 min till recovery of block to S1 level. Motor blockade will be assessed by modified Bromage scale at 1, 2, and 5 min after giving spinal anesthesia, then at every 5 min till 30 min and then every 15 min till full recovery of motor level.

Secondary

MeasureTime frame
Sedation and post-operative analgesia by Visual Analogue ScaleTimepoint: Ramsay level of sedation scale will be used to assess sedation at 1, 2, and 5 min after giving spinal anesthesia, then at every 5 min till 30 min and then every 15 min till discharge from postanesthesia care unit. Postoperative pain intensity will be assessed using a 10-point visual analog scale (VAS) for 24 hours. Postoperative nausea, vomiting, and shivering will be observed till the discharge of the patient.

Countries

India

Contacts

Public ContactDR ARNAB RAY

KPC Medical College and Hospital

drsourabhroy@gmail.com9836275531

Outcome results

None listed

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