SCALP BLOCK VS PROPOFOL INFUSION FOR HAEMODYNAMIC STABILITY IN NEUROSURGERY CASES.

Not yet recruiting

Conditions: Other specified disorders of nervous system in diseases classified elsewhere,

Registration Number: CTRI/2019/03/018024

Lead Sponsor: LILAVATI HOSPITAL AND RESERCH VCENTRE

Brief Summary: TITLE: To compare the hemodynamic response to incision with scalp block VS iv propofol infusion in neurosurgical procedures.

RATIONALE: The incision on scalp is a highly noxious stimulus that cause hemodynamic changes which are undesirable especially in neurosurgical procedures.Hence we decided to compare the hemodynamic effects of Scalp Block VS Propofol infusion to incision/pinning and to study post operative pain using VAS scoring system.

SETTING: Study carried out in Lilavati Hospital and Reserch Centre.

STUDY DESIGN: Prospective ,randomised study.

SAMPLE SIZE: 40(divided into 2 groups).

GROUP A: All patient recieving scalp block.

GROUP B: All patents recieving Propofol; infusion.

OUTCOME MEASURES:Following measures will be recorded during the study- "heart rate and blood pressure" changes preoperatively ,intraoperatively and postoperatively 2 hours after extubation .,along with the VAS scoring for postoperative pain.

STATISCAL ANALYSIS:Data will be analysed using SPSSV15.0(Statistical package for Social Sciences,Version 15.0)Data will be given as Mean +\_ SD(n) for continous data and number(percentage) for categorical data..Comparison of means will be carried out by Student’s unpaired test for numerical data .Fischer Exact Proabibility test or Chisquare test will be applied to compare percentages for categorical data .Paired t test will be applied to compare MEANS AT VARIOUS TIME POINTS FOR SAME PATIRNTS.Mann Whitney U test and Wilcoxan Signed Rank test will be applied to non normal data.All statistical tests will be two tailed.Alpha Level of significance will be taken as P<0.05.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

ASA I,II,III WILLING TO PARTICIPATE.
ALL MAJOR CRANIOTOMY CASES.
ABLE TO COMPREHEND AND COOPERATE.

Exclusion Criteria

PATIENT REFUSAL.
ASA GRADE IV.
ALLERGY TO BUPIVACAINE.
ALCOHOL AND SUBSTANCE ADDICTION.
ANTICOAGULANT MEDICATIONS.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HEART AND BLOOD PRESSURE.	BEFORE ANESTHESIA INDUCTION, AFTER ANESTHESIA INDUCTION,AFTER INCISION/PINNING,IMMEDEIATE AFTER EXTUBATION,15MIN,30MIN,45MIN,60MIN,90MIN,120MIN AFTER EXTUBATION.

Secondary Outcome Measures

Name	Time	Method
POST OPERATIVE PAIN USING VAS SCORING SYSTEM.	BEFORE ANESTHESIA INDUCTION, AFTER ANESTHESIA INDUCTION,AFTER INCISION/PINNING,IMMEDEIATE AFTER EXTUBATION,15MIN,30MIN,45MIN,60MIN,90MIN,120MIN AFTER EXTUBATION.

Trial Locations

Locations (1): LIAVATI HOSPITAL AND RESERCH CENTRE.
🇮🇳
Mumbai, MAHARASHTRA, India
LIAVATI HOSPITAL AND RESERCH CENTRE.
🇮🇳Mumbai, MAHARASHTRA, India
SNIGDHA KUMARI
Principal investigator
07909059807
snigdhasingh19590@gmail.com