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Clinical Trials/CTRI/2013/08/003937
CTRI/2013/08/003937Not yet recruitingPhase 4

Study of the effect of intrathecal dexmedetomidine as an adjuvant in spinal anesthesia for Gynaecological Surgery.

Peoples Hospital1 site in 1 country60 target enrollmentStarted: August 9, 2013Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
motor block regession in bromage score,sensory

Study Overview

Brief Summary

•Study the effect of intrathecal dexmedetomidine for prolongation of spinal analgesia..

OBJECTIVES:-

•To see the effect of intrathecal dexmedetomidine for prolongation of spinal analgesia.

•To study onset and level of sensory and motor block.

•To monitor the quality of analgesia with its duration.

•To study the side effects if any.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.ASA grade I and II patients.
  • 2.Age group 18-60 years.
  • Gynecological surgeries.

Exclusion Criteria

  • Patient refusal or unco-opretive patient
  • Bleeding disorder
  • Neurological deficit.
  • History of seizures 5.

Outcomes

Primary Outcomes

motor block regession in bromage score,sensory

Time Frame: 4 to 8 hours after intra thecal injection

block regession by pin prick senstion to

Time Frame: 4 to 8 hours after intra thecal injection

analgesic in post operative period,any other side

Time Frame: 4 to 8 hours after intra thecal injection

dermatomes,time to requirement to first

Time Frame: 4 to 8 hours after intra thecal injection

effects like nausea,headache,itching etc

Time Frame: 4 to 8 hours after intra thecal injection

Secondary Outcomes

  • sensory block regession by pin prick senstion to(dermatomes,time to requirement to first)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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