| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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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. |
|
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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. |
|
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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)?
|
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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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