Study to check the effect of drug called Dexmedetomidine on blood flow regulation to brain in patients having brain tumour

Phase 4

Completed

• Conditions: neurologically stable patients

• Registration Number: CTRI/2014/10/005148
• Lead Sponsor: Sri Chitra Tirunal Institute for Medical Science and Technology

Brief Summary

Informed consent will be taken from Patients satisfying inclusion criteria. Consenting patients will be included in the study protocol.

Patient will be shifted in to operating room. Monitors will be attached and baseline HR, NIBP, SpO2, EtCO2  will be recorded.

Ultrasound scan ( grey scale & Doppler ) of  bilateral carotid arteries to rule out plaque, stenosis or other flow limiting lesions.

 Under Lignocaine (2%) skin infiltration I.V access and arterial access will be obtained.

**baseline analysis :**

·         TCCDI analysis of Right  and left Middle cerebral artery flow velocity

·         Baseline flow velocity for 5 seconds

·         Flow velocity Compression of Rt. Side carotid artery (  3 sec )

·         Flow velocity  After release of compression for 5 seconds

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 infusion of  Inj. Dexmedetomidine 1 mcg/Kg/ 10 min by infusion pump.

Continuous Vital parameters monitoring 10 min ( HR/IBP/SpO2/EtCO2 )

**Post dexmedetomidine analysis :**

Continuous Vital parameters monitoring ( HR/IBP/SpO2/EtCO2 )

·         TCCDI analysis of Right and left  MCA flow velocity

·         Baseline flow velocity for 5 seconds

·         Flow velocity Compression of Rt. Side carotid artery (  3 sec )

·         Flow velocity  After release of compression for 5 seconds

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 After induction routine anaesthesia protocol will be employed.

 **Data collection:** manual entry into the study proforma.

**Observations:**

Baseline heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation before starting the anesthesia induction .

Baseline recording of  MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial colour Doppler imaging.

Auto regulation assed by Transient hyperaemic response

The hemodynamic variables (HR ,SBP,DBP and MAP) ,oxygen saturation, End tidal carbon dioxide (EtCO2) & respiratory rate during induction with Dexmedetomidine

Heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation after induction with Dexmedetomidine.

Recording of  MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial  colour Doppler imaging after induction with Dexmedetomidine.

Auto regulation - Transient hyperaemic response  after induction

Any hemodynamic and respiratory adverse  events such as hypotension, hypertension, Bradycardia, oxygen desaturation and other events will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-11
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• two groups (15 patients in each group) Group I.
• patients with unilateral Glioma, Glascow coma scale 15, American society of anesthesiology Grading 1 and 2. Group II.
• patients having no intracranial pathology ( patients posted for lumbar and thoracic spinal cord surgeries (laminectomy, discectomy), American society of anesthesiology Grading 1 and 2.

Exclusion Criteria

• Patient refusal, American society of Anesthesiology (ASA) class 3 and above, Age less than 18 years and more than 35 years, Preoperative Glasgow coma scale (GCS) <15, Intracranial vascular abnormalities, Documented cases of Carotid stenosis, atherosclerosis, Infra tentorial / posterior fossa tumours, Emergency surgery, Preoperative heart rate <50 bpm, Systemic hypertension stage III & above, Heart block, Known allergy to Dexmedetomidine, Patient on beta blockers, Coronary artery disease, Left ventricular dysfunction,Pregnant or Nursing woman.
• Antihypertensive medication with alpha-methyldopa, clonidine or other a2-adrenergic agonist, Vascular pathology ( Plaque, calcification, narrowing, stenosis, abnormal flow pattern ) identified during pre-induction sonography, Difficulty in localizing intracranial vasculature by TCCDI, Abnormal bone window, Participation in another drug study during the preceding 1 month period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effect of dexmedetomidine on cerebral vascular autoregulation	immediately after completion of Dexmedetomidine infusion

Secondary Outcome Measures

Name	Time	Method
cerebral hemodynamics, and cerebral vascular resistance	immediately after infusion of Dexmedetomidine

Trial Locations

Locations (1)

Sri chitra tirunal institute for medical science and technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sri chitra tirunal institute for medical science and technology

🇮🇳Thiruvananthapuram, KERALA, India

Arulvelan

Principal investigator

9048842282

drarulvelan@gmail.com