To Study effectiveness of 2 different medicines in preventing change in patient vitals both before and after inserting an airway device in patients taken for surgery
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/10/037358
- Lead Sponsor
- JHALAWAR MEDICAL COLLEGE AND HOSPITAL
- Brief Summary
**AIMS AND OBJECTIVES:**
Study “COMPARISON OF DEXMEDETOMIDINE-PROPOFOL VERSUS
FENTANYL-PROPOFOL FOR INSERTION OF BLOCKBUSTER LMA UNDER
GENERAL ANAESTHESIA - A RANDOMIZED DOUBLE-BLINDED CLINICAL
TRIAL†will be done in 120 ASA grade I & II patients to compare: -
1. **Primary objective-**
ï‚· Monitoring of haemodynamic parameters,
ï‚· ETCO2 and
ï‚· SpO 2 during insertion of device
2. **Secondary objective-**
ï‚· Quality of insertion : (a) Ease of insertion
(b) Number of attempts
(c) Time taken for insertion
ï‚· Manoeuvres used for intubation
ï‚· Peri- and post-operative complications
**SAMPLE SIZE SELECTION:**
Sample size will be calculated by using open epi software version 6, open source
calculator ss proper, at power 80% and 95% confidence interval is 40 in each group.
**SELECTION OF GROUPS:**
The patients will be randomly divided into 3 groups with 40 in each group, using
computer generated random numbers.
 Group PD - 1 µg/kg dexmedetomidine diluted to 10 ml with 0.9% normal saline
(NS) over ten minutes by an infusion pump followed by 5 ml of NS over 2 minutes.
 Group PF - Injection fentanyl 1 µg/kg diluted to 10 ml with 0.9% NS over 10
minutes by an infusion pump followed by 5 ml of NS over 2 minutes.
 Group P – only 10ml NS & 5ml NS will be given over 10mins and 2 mins
respectively by an infusion pump.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- a) ASA grade I and II.
- b) Aged 18-50 years.
- c) MPG I and II d) Either gender undergoing general anaesthesia.
- e) Elective surgeries ≤ 120mins f) Weight- 50 -80 kg.
a) Difficulty in understanding the study protocol/ denying consent b) History of sleep apnoea c) Known allergy to the study medication d) Bronchial asthma e) Respiratory or cardiac dysfunction f) Acute upper respiratory tract infection g) Renal, cerebral insufficiency h) Liver impairment and bleeding disorders i) Hiatus hernia, pregnancy, emergency surgeries j) Taking medications for psychiatric diseases k) Chronic or acute intake of sedative or analgesic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Monitoring of haemodynamic parameters, baseline vitals ,vitals before and after giving study drug , vitals every 1 min upto 30 mins intraop. 2.ETCO2 and baseline vitals ,vitals before and after giving study drug , vitals every 1 min upto 30 mins intraop. 3.SpO2 during insertion of device baseline vitals ,vitals before and after giving study drug , vitals every 1 min upto 30 mins intraop.
- Secondary Outcome Measures
Name Time Method 1.Quality of insertion : (a) Ease of insertion
Trial Locations
- Locations (1)
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL, JHALAWAR
🇮🇳Jhalawar, RAJASTHAN, India
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL, JHALAWAR🇮🇳Jhalawar, RAJASTHAN, IndiaDR NEELU SHARMAPrincipal investigator9782480455drneelu13@gmail.com