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Clinical Trials/CTRI/2019/05/019341
CTRI/2019/05/019341Not yet recruitingPhase 1/2

A prospective randomized controlled trial to compare the efficacy and safety of different doses of clonidine when used as an adjuvant to intrathecal bupivacaine

J J hospital1 site in 1 country90 target enrollmentStarted: January 6, 2019Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Block height

Study Overview

Brief Summary

Spinal anesthesia has been the technique of choice for lower limb and abdominal surgeries and is preferred over general anesthesia. Many adjuvants have been studied to prolong the duration of action of spinal anesthesia. In our study we would like to study the effects of adding different doses of clonidine as a adjuvant to bupivacaine in subarachnoid block and observe the effects and adverse events

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I or II normotensive patients undergoing elective orthopaedic surgery.

Exclusion Criteria

  • ASA III & above, patients with cardiovascular, renal, liver dysfunction, allergy to clonidine or bupivacaine, short height (<130cm), obese(BMI > 30kg/m2) or with contraindication to spinal.

Outcomes

Primary Outcomes

Block height

Time Frame: 1year

Duration of analgesia/sensory block

Time Frame: 1year

Hemodynamic variations-pulse, MAP

Time Frame: 1year

Complications

Time Frame: 1year

Secondary Outcomes

  • Hemodynamic effects-pulse and MAP(Complications)

Investigators

Sponsor
J J hospital
Sponsor Class
Government medical college

Study Sites (1)

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