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Clinical Trials/CTRI/2022/05/042376
CTRI/2022/05/042376Not yet recruitingPhase 3

Effect Of Dexmedetomidine Infusion On Intraoperative Hemodynamics And Anesthetic Requirements In Patients Undergoing Elective Spine Surgery: A Prospective Randomized Control Trial

NOT APPLICABLE1 site in 1 country50 target enrollmentStarted: May 31, 2022Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
BLOOD LOSS

Study Overview

Brief Summary

Dexmedetomidine is a highly selectivealpha-2-agonist that has been widely used in anesthetic practice as an adjuvantbecause of its desirable properties . It has anti-nociceptive , analgesic,opioid sparing and sedative properties without respiratory depression.itdecreases sympathetic tone thereby reducing heart rate and blood pressure. Italso increases the stress response to surgery.the dose of dexmedetomidine oftenquoted in the literature is a bolus of 1 mcg/kg/hr over 10 minute followed byinfusion of 0.2-0.7 mcg/kg/hr,but this dose frequently results in brady cardiaand hypotension

Theprimary aim of the study is to evaluate the effect of dexmedetomidine infusionon intraoperative blood loss , haemodynamic changes and anaestheticrequirements in the patients undergoing elective spine surgery The secondaryaim is to study its effect on intraoperative anesthetic and analgesic requirementsduring the surgery

Study Design

Study Type
Interventional
Allocation
Adaptive randomization, such as minimization
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • •All patients giving consent Elective spinal surgeries only Patients aged >18 years & < 65 years Patients of either sex ASA Grade I & II.

Exclusion Criteria

  • •PREGNANT PATIENTS PATIENTS SUFFERING FROM HYPERTENSION UNCONTROLLED DIABETES MELLITUS MORBID OBESITY COPD SEVERE RENAL, HEPATIC, CARDIAC DYSFUNCTION EMERGENCY SPINE SURGERY HISTORY OF DRUG ABUSE.

Outcomes

Primary Outcomes

BLOOD LOSS

Time Frame: HYPOTENSION - EVERY 30 MINUTES | BLOOD LOSS - EVERY 30 MINUTES | ANALGESIA USE - EVERY 30 MINUTES

HYPOTENSION

Time Frame: HYPOTENSION - EVERY 30 MINUTES | BLOOD LOSS - EVERY 30 MINUTES | ANALGESIA USE - EVERY 30 MINUTES

ANALGESIA USE

Time Frame: HYPOTENSION - EVERY 30 MINUTES | BLOOD LOSS - EVERY 30 MINUTES | ANALGESIA USE - EVERY 30 MINUTES

Secondary Outcomes

  • ANALGESIA REQUIREMENT(ANALGESIA USE - EVERY 1 HOUR)

Investigators

Sponsor
NOT APPLICABLE
Sponsor Class
Other [nil]

Study Sites (1)

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