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CTRI Number  CTRI/2019/01/016895 [Registered on: 04/01/2019] Trial Registered Retrospectively
Last Modified On: 19/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effect of different gas mixtures on upper airway using Proseal Laryngeal mask airway. 
Scientific Title of Study   To compare the effects of different gas mixtures used for anaesthesia and for Proseal LMA cuff insufflation on the intra cuff pressure and postoperative upper airway morbidity.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Beenish Bashir  
Designation  Senior resident. Lnjp hospital. Maulana Azad Medical college. New Delhi. 
Affiliation  Batra Hospital and Medical research centre. New Delhi. 
Address  LNJP Hospital.Jawaharlal Nehru Marg.New Delhi.
Department of Anaesthesia, Batra Hospital and Medical Research Centre. 1, Tughlakabad Institutional Area.MB road.New Delhi.110062.
South
DELHI
110002
India 
Phone  011-23230733  
Fax    
Email  beenishfaiz7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pavan Gurha 
Designation  Head of Department. 
Affiliation  Batra Hospital and Medical Research Centre. 
Address  Department of Anaesthesia.Batra Hospital and Medical Research Centre.1, Tughlaqabad Institutional Area,MB road.New Delhi.
Department of Anaesthesia.Batra Hospital and Medical Research Centre.1, Tughlaqabad Institutional Area,MB road.New Delhi.
South
DELHI
110062
India 
Phone  9811088632  
Fax    
Email  pavan_gurha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Beenish Bashir  
Designation  Senior resident. Lnjp hospital. Maulana Azad Medical college. New Delhi. 
Affiliation  Batra Hospital and Medical research centre. New Delhi. 
Address  LNJP Hospital.Jawaharlal Nehru Marg.New Delhi.
Department of Anaesthesia.Batra Hospital and Medical Research Centre.1, Tughlaqabad Institutional Area,MB road.New Delhi.
South
DELHI
110002
India 
Phone  011-23230733  
Fax    
Email  beenishfaiz7@gmail.com  
 
Source of Monetary or Material Support  
Batra Hospital and Medical Research Centre.1, Tughlaqabad Institutional Area,MB road.New Delhi.110062. 
 
Primary Sponsor  
Name  Batra hospital and medical research centre New Delhi 
Address  Batra hospital and medical research centre. Tughlakabad Institutional Area. Mehrauli Badarpur road. New Delhi. 110062. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Beenish Bashir   Batra hospital and medical research centre. New Delhi.  Operation Theatre,Department of Anaesthesia.Batra hospital and medical research centre.1, Tughlaqabad Institutional Area, MB road.New Delhi.
South
DELHI 
8826137055

beenishfaiz7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board. Batra Hospital and Medical Research Center. New Delhi.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  90 adult patients aged 18 to 80 years of either sex, of ASA status l, II or IIl, undergoing elective laparoscopic surgery under General Anaesthesia lasting for upto 2 hours using LMA Proseal., (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparing effects of different anaesthetic gas mixtures on pro seal LMA cuff insufflation and postoperative upper airway complications.  90 patients were randomised into 3 groups of 30 patients as NN group where PLMA cuff was inflated with O2 + N2O mixture and anaesthesia maintained with O2 + N2O gas, AN group where PLMA cuff was inflated with room air and anaesthesia maintained with O2 + N2O gas and AA group where PLMA cuff was inflated with room air and anaesthesia maintained with O2 +Air. The cuff pressure was measured at the beginning and end of surgery with a manometer and postoperative airway complications were recorded. 
Intervention  Proseal LMA  90 patients were randomized into 3 groups of 30 patients each as NN group where PLMA cuff was inflated with O2 + N2O mixture and anaesthesia maintained with O2 + N2O gas, AN group where PLMA cuff was inflated with room air and anaesthesia maintained with O2 + N2O gas and AA group where PLMA cuff was inflated with room air and anaesthesia maintained with O2 +Air. The cuff pressure was measured at the beginning and end of surgery with a manometer and postoperative airway complications were recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. ASA- I, II and III.
2. Age between 18 to 80 years.
3. Patients receiving general anaesthesia for laparoscopic surgeries. 
 
ExclusionCriteria 
Details  1. Severe gastroesophageal reflux disease.
2. Morbid obesity [Body mass index (BMI) > 40]
3. Surgery in prone position.
4. Any symptoms of acute upper respiratory tract infection.
5. Preoperative SpO2 of <92% at room air.
6. Patients with known anatomical laryngo-tracheal abnormalities.
7. Patients with ASA physical status grade > III. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cuff pressure   At the end of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Sore throat, hoarseness,cough  At the time of shifting from PACU and after 24 hours. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2013 
Date of Study Completion (India) 01/09/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The present study was conducted to compare the effects of different gas mixtures used for anaesthesia and for Proseal LMA cuff insufflation on the intra cuff pressure and postoperative upper airway morbidity.
After approval by the Hospital Ethics Committee, the present study was conducted in Ninety ASA grade I, II or III adult patients of either sex in the age group of 18 to 80 years admitted at Batra Hospital & Medical Research Centre, New Delhi who underwent elective laparoscopic surgery under general anaesthesia using PLMA. They were randomly divided into three groups (NN) (AN) and (AA) depending on the gas used for insufflating their cuffs and for maintenance of anaesthesia during the surgical procedure. In all the patients, cuff pressure monitoring was done both at the beginning and at the end of procedure with the help of a manometer and the rise in cuff pressure if any noted at the end of the surgery. The incidence of post operative respiratory complications was assessed in the PACU and 24 hours post operative.
There was no statistically significant difference in the demographic data between the three groups. All the three groups were comparable in terms of age, weight, height, sex, ASA grade, duration of surgery, PLMA used, number of attempts and the volume of air/ O2+N2O
mixture injected into the cuff at the time of insertion of PLMA. We found that-
The mean cuff pressure in all the three groups at the beginning of surgery was comparable and did not differ significantly ( P > 0.05)
At the end of surgery, the rise in cuff pressure was significantly higher in the (AN)
group where air was used to insufflate the PLMA cuff and O2+N2O was used as a part
of balanced anaesthesia where as there was no rise in the cuff pressure of the group where only air was used both to insufflate as well as to maintain anaesthesia i.e (AA) as measured by the manometer. In the third group, i.e.(NN) group, where O2+N2O mixture was used to both insufflate the cuff as well as for maintenance, the
rise in cuff pressure was quite less than the (AN) group. The difference in the rise of cuff pressure over time between these three groups was found to be statistically significant (P< 0.001).
The incidence of sore throat was significantly high in the (AN) group than (NN) or (AA) group both in the PACU (P < 0.007) and also after 24 hours (P < 0.001). The incidence of cough and hoarseness amongst the three groups was comparable and statistically insignificant (P > 0.05).

 
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