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Clinical Trials/CTRI/2024/07/071589
CTRI/2024/07/071589Not yet recruitingPhase 2

To compare and evaluate the effect of dexmedetomedine and fentanyl as adjuvant to intrathecal ropivacaine 0.5 percent heavy in lower limb surgery.

Acharya Vinobha Bhave Rural Hospital1 site in 1 country60 target enrollmentStarted: August 27, 2024Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To evaluate the onset and duration of sensory and motor blockade when Dexmeditomedine and fentanyl used as an adjuvant to ropivacaine 0.5% heavy in lower limb surgeries
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The central nervous system (CNS) comprises the brain and spinal cord. The term neuraxial anesthesia refers to the placement of local anesthetic in or around the CNS. Spinal anesthesia is a neuraxial anesthesia technique in which local anesthetic is placed directly in the intrathecal space. This will be a randomized trial to test the effectiveness of Dexmedetomidine and fentanyl to intrathecal ropivacaine 0.5% heavy in lower limb surgeries.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA physical status I and II
  • •Patient undergoing elective lower limb surgeries, duration of surgery 120-180 minutes
  • •Age between 18 to 50 years old
  • •Patient giving informed consent.

Exclusion Criteria

  • •Patients with a history of elevated renal parameters, elevated hepatic parameters, heart diseases of ischemic nature, disease related to heart valves, systemic hypertension, history of cancer, sepsis, clotting disturbances and disorders
  • •Consumption of narcotics or non steroidal anti inflammatory drugs a day prior to surgery
  • •Drug allergy
  • •Patients who don’t consent to participate in the study.

Outcomes

Primary Outcomes

To evaluate the onset and duration of sensory and motor blockade when Dexmeditomedine and fentanyl used as an adjuvant to ropivacaine 0.5% heavy in lower limb surgeries

Time Frame: 06 hours

Secondary Outcomes

  • To evaluate the duration of analgesia, hemodynamic stability, side effects

Investigators

Sponsor
Acharya Vinobha Bhave Rural Hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Akansha Singhal

Acharya Vinobha Bhave Rural Hospital, JNMC

Study Sites (1)

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