A clinical trial to compare the effect of two group of drugs while giving anesthesia in patients posted for major surgeries.

Not Applicable

Recruiting

• Conditions: ASA 1 and ASA 2 patients posted for surgery

• Registration Number: CTRI/2016/12/007572
• Lead Sponsor: Priyanka Dabas

Brief Summary

A randomized clinical trial : hemodynamic effects and ease of I gel insertion in dexmedetomidine - propofol vs propofol- fentanyl group with sample size of 40 in each group . total 80 cases ( ASA 1 and ASA 2 posted for elective surgery)  will be studied and their parameters will be assesed in terms of heart rate , o2 saturation , respiratory rate and blood pressure at different point of time before and after induction after giving respective drugs . ease of Igel insertion will be assesed as per their degree of jaw relaxation . Study hypothesis :

Introduction 

Aim

Objective

Review of literature

materials and methods : study design

study setting

study population

sample size

inclusion criteria

exclusion criteria

randomization

methodology

study duration

data analysis

references

annexure 1 ( consent )

annexure 2

annexure 3 ( patient performa )

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-18
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.ASA grade I & II.
• 2.18-60 years of age.
• 3.Weight 35-80kgs.
• 4.Who gives informed written consent.
• 5.Patients scheduled to undergo elective surgical procedures .

Exclusion Criteria

• 1.Risk of gastric aspiration.
• 2.Patient who refuse for the study or have any known allergy.
• 3.Patients undergoing oral surgeries.
• 4.Those with Hepatic/ Renal/cardio-pulmonary abnormality, bleeding diathesis.
• 5.ASA grade III & IV patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Heart rate, Respiratory rate ,Non invasive blood pressure and Oxygen saturation will be recorded before induction	Baseline, 30sec after induction, 1min, 3min,5min,10min and 15min after insertion of I-gel

Secondary Outcome Measures

Name	Time	Method
jaw mobility and coughing / bucking	2 optimum for i gel insertion

Trial Locations

Locations (1)

Kasturba Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

Kasturba Medical College Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Priyanka Dabas

Principal investigator

9844619200

priyankadabas88@gmail.com