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Clinical Trials/CTRI/2025/01/079554
CTRI/2025/01/079554Not yet recruitingPhase 4

Comparison Of Levo-Bupivacaine Fentanyl and Levo-Bupivacaine Fentanyl with Magnesium Sulphate as Adjuvants to Spinal Anaesthesia in Infra-umblical Surgeries

Keerthana J1 site in 1 country60 target enrollmentStarted: February 17, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare the duration of sensory block when intrathecal Magnesium sulphate is added with low doseLevo Bupivacaine Fentanyl Spinal Anesthesia with spinal Anesthesia given only with Levo bupivacaine & Fentanyl

Study Overview

Brief Summary

This study is a Randomised double blinded control study in which the participants will equally be divided into 2 groups.

The person performing the procedure will be unrealated to the study and will be performing the spinal anesthesia technique with drugs given to him in sealed envelopes.

The principle investigator who will be blinded to the drug given will be noting the required paremeters in the post-operative period

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Day(s) to 60.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • Age between 20years to 60 years All patients undergoing Infraumblical surgery.

Exclusion Criteria

  • Patients not willing for spinal anesthesia Patients with severe cardiac diseases Patients with age less than 20 years and more than 60 years Patients with coagulopathies Patients with infections in the spine.

Outcomes

Primary Outcomes

To compare the duration of sensory block when intrathecal Magnesium sulphate is added with low doseLevo Bupivacaine Fentanyl Spinal Anesthesia with spinal Anesthesia given only with Levo bupivacaine & Fentanyl

Time Frame: VAS score will be assessed every 2 hours in the post operative period until it is less than 4

Secondary Outcomes

  • To compare the onset of sensory and motor blockade in both the groups(every minute for first 5 minutes)

Investigators

Sponsor
Keerthana J
Sponsor Class
Other [Self ]
Responsible Party
Principal Investigator
Principal Investigator

Keerthana J

ACSMCH

Study Sites (1)

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