Comparison of two medications Dexmedetomidine and Magnesium Sulphate for control of blood pressure and heart rate during surgery and their effects on pain relief after surgery

Not yet recruiting

• Conditions: Joint disorder, unspecified, (2) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement,

• Registration Number: CTRI/2020/01/022971
• Lead Sponsor: St Johns Medical College And Hospital Bangalore

Brief Summary

This study is a randomised, double blind, parallel Group, single centre trial comparing the efficacy between intravenous Dexmedetomidine given as Bolus dose of Magnesium Sulpfate 30mg/kg in 100ml Normal Saline over 15 min followed by maintenance of 8mg/kg/hr until end of surgery and intravenous Magnesium Sulphate given as  Bolus dose of Dexmedetomidine 1mcg/kg in 100ml Normal Saline over 15 min followed by maintenance of 0.3mcg/kg/hr until end of surgery. The duration of the trial will be a period of two years. The primary outcome measured are intraoperative  hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR). The secondary outcome is postoperative pain scores measured with numerical rating scale.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-16
• Study Start: 2020-01-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults aged 18-59 years, undergoing elective lumbar spine surgeries Either sex American physical status (ASA) I and II.

Exclusion Criteria

Known history of hypersensitivity to drugs used Pregnant or lactating woman Previous spine surgeries Preexisting neuromuscular diseases or myopathy Coagulation disorders Patient on Calcium channel blockers and Beta blockers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR)	Every 5min for first half hour and then every 15min thereafter until end of surgery.

Secondary Outcome Measures

Name	Time	Method
postoperative pain by measuring numeric rating scale	Parameters are seen in recovery room (0 min, 30min, 1hr, 2hrs) and in ward at 4hrs, 6hrs, 8hrs, 10hrs, 12hrs.

Trial Locations

Locations (1)

St Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

St Johns Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Albin Aloysius Chettanil

Principal investigator

08951190342

albinchettanil@gmail.com