Comparison between IV dexmedetomidine (to reduce pain and increase in heart rate, blood pressure) and local lignocaine infiltration to reduce hemodynamic response (increase in heart rate,blood pressure) to skull pin application (to stabilize head) during neurosurgery

Completed

• Conditions: AGED BETWEEN 18-70 YEARS, BELONGING TO AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS 1 AND 2, SCHEDULED FOR ELECTIVE CRANIOTOMY UNDER GENERAL ANESTHESIA

• Registration Number: CTRI/2012/04/002595
• Lead Sponsor: KASTURBA HOSPITAL KASTURBA MEDICAL COLLEGE MANIPAL

Brief Summary

In this patient investigator blinded trial 50 patients aged 18-70 years scheduled for elective craniptomy will be recruited. The objective of the study is to find out whether intravenous dexmedetomidine 1 mcg/kg given over 10 minutes or local infiltration of 2% lignocaine (3ml per pin site) is a better agent in obtunding the hemodynamic response to skull pin application. Heart rate and mean arterial pressure will be recorded and compared between the groups (apart from baseline) at 1,2,3,4,5,10 and 15 minutes following pin application. Heart rate less than 40/minute, increase by 30%, change in mean arterial pressure by 30% will be regarded as significant. Entropy values at corresponding time intervals will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-14
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Patients scheduled for elective craniotomy in supine or lateral position under general anaesthesia.
• 2.American Society of Anesthesiologists Physical Status (ASAPS) 1or 2 3.Age between 18 to 70 years.

Exclusion Criteria

1.Hypertension 2.Ischaemic heart disease 3.2nd or 3rd degree heart block 4.Pregnancy or lactation 5.Signs and symptoms of raised intracranial pressure 6.Head injury 7.Previous craniotomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HEART RATE (less than 40 beats per minute and 30% increase)AND MEAN ARTERIAL PRESSURE (30% change) RESPONSE TO SKULL PIN APPLICATION	1, 2, 3, 4, 5, 10 AND 15 minutes after pin application

Secondary Outcome Measures

Name	Time	Method
entropy values	1,2,3,4,5,10,15 minutes after pin application

Trial Locations

Locations (1)

KASTURBA HOSPITAL, MANIPAL; 🇮🇳 Udupi, KARNATAKA, India

KASTURBA HOSPITAL, MANIPAL

🇮🇳Udupi, KARNATAKA, India

KRISHNA H M

Principal investigator

9448983314

hmkrishna20032002@gmail.com