| CTRI Number |
CTRI/2016/10/007374 [Registered on: 17/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different supraglottic airway devices for laproscopic hernioplasty |
|
Scientific Title of Study
|
Comparison of I-gel vs LMA Proseal as airway for laproscopic hernioplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 062/15 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Richa Gupta |
| Designation |
Resident Doctor |
| Affiliation |
government medical collage, surat |
| Address |
206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli, nanpura, surat. department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat. Surat GUJARAT 395001 India |
| Phone |
9099006849 |
| Fax |
|
| Email |
richa.gmcs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neeta Kavishvar |
| Designation |
Head of Department |
| Affiliation |
government medical collage, surat |
| Address |
flat 2/B, Prarthna apartment, ravishankar sankul, bhatar char rasta, surat. 395017 department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat. Surat GUJARAT 395017 India |
| Phone |
9825615264 |
| Fax |
|
| Email |
neeta_kavishvar@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Richa Gupta |
| Designation |
Resident Doctor |
| Affiliation |
government medical collage, surat |
| Address |
206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli, nanpura, surat. department of anaesthesiology, new civil hospital, government medical collage, majura gate, surat. Surat GUJARAT 395001 India |
| Phone |
9099006849 |
| Fax |
|
| Email |
richa.gmcs@gmail.com |
|
|
Source of Monetary or Material Support
|
| New Civil Hospital, Surat |
|
|
Primary Sponsor
|
| Name |
Dr Richa Gupta |
| Address |
206,north view building, laughing buddha circle, near sneh-milan garden, near kadampalli,nanpura, surat 395001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Richa Gupta |
new civil hospital, surat |
Surgery OT,new civil hospital, government medical collage, majura gate, surat,395001 Surat GUJARAT |
9099006849
richa.gmcs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| human research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with hernia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-gel |
I-gel is a type of supraglottic airway device |
| Comparator Agent |
Proseal LMA |
Proseal LMA is a type of supraglottic airway device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
body weight 40-60kgs |
|
| ExclusionCriteria |
| Details |
Obese patients,known difficult airway, mouth opening <2.5 fingers, cervical spine disease, patients prone to aspiration such as hiatus hernia and GERD and emergency surgeries. Patients with systemic illness.Those patients who does not give consent to be part of the study are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a)To compare two supraglottic devices I gel vs LMA Proseal in terms of respiratory mechanics during positive pressure ventilation in laproscopic hernioplasty
b)To study and compare two devices for ease of insertion and effectiveness of insertion.
|
peak airway pressure, inhaled tidal volume, exhaled tidal volume, leak, minute ventilation, etco2 will be recorded 10 mins after placement of device, 10 mins after carboperitonium, 10mins after release of co2. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To study the hemodynamic parameters with the above two devices in laproscopic hernia
b)Study adverse events in the group in form of trauma to airway and post operative sore throat and other complications.
|
hemodynamic parameters at 1, 3,5,7,10 and 15 mins after device insertion, and after removal of device.
immediate post-operative complications and delayed post-operative complications (after 12 hrs of surgery). |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2015 |
| Date of Study Completion (India) |
10/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1.Comparision of clinical performance of the Igel with LMA proseal
By- Gaurav Chauhan. Pavan Nayar, Anita Seth, Kapil Gupta, Mamta Panwar, Nidhi Agrawal.
Department of Anesthesia and Intensive Care, Sadarjang Hospital, New Delhi, India
Journal of anaesthesiology clinical pharmacology/jan-mar13/vol29/issue1/pg56-60
2.Comparison of Clinical Performance of I-Gel™ with LMA—Proseal™ in Elective Surgeries
Ishwar Singh,1 Monika Gupta,2 and Mansi Tandon3
Department of Anesthesiology, Jaipur Golden Hospital, New Delhi.
Indian J Anaesth. Jun 2009; 53(3): 302–305
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective randomized controlled study which will be conducted on 60 patients who are within the decided inclusion criterias. 60 patients will be then randomly allotted in two groups GROUP I and GROUP P of 30 each by computer based randomized system. Patients will be premedicated with inj glycopyrrolate 0.2mg i.m, in fortwin 0.6mg/kg i.m. In operation theatre, inj midazolam 1mg i.v will be given and basal reading of HR, SBP, DBP, Oxygen saturation, will be noted. After induction with inj propofol 3mg/kg i.v , with loss of eyelash reflex, inj rocuronium 0.9mg/kg will be administered. After mask ventilation for 1 minute appropriate size airway device according to the group which patient belongs, will be inserted. Effective ventilation with the device will be defined as bilateral equal chest movements and normal capnograph. Hemodynamic readings will be taken at 1,3,5,7,10,15minutes after insertion of device . Insertion attempts and ease of insertion will be noted. More than two intertions attempts will be considered as a failure and that patient will be excluded from the study and patient will be intubated conventionally. IPPV will be given to maintain EtCO2 between 30-45mm hg. Patient will be maintained on oxygen, nitrous oxide, isoflurane, and intermittent inj vecuronium iv. Ryle’s tube will be inserted through the device and its ease of insertion and number of attempts will be noted. Oxygen saturation, EtCO2 , airway pressure, inhaled tidal volume, exhaled tidal volume, minute ventilation is noted before, and after ten minutes of CO2 insuffation and 10minutes after release of CO2. After surgery patient will be reversed with inj neostigmine 0.05mg/kg i.v and inj. Glycopyrrolate 0.008mg/kg i.v. After patient is conscious and follows verbal command patient will be transferred to post operative recovery room. Complications such as incidence of cough, laryngospasm, blood on device, lip and dental trauma will be noted. Each patient will be questioned after 12hrs of surgery regarding sore throat, dysphagia, dysphonia, numbness over tongue or oropharynx. Mean and SD will be calculated and data will be analysed using paired t-test using EPI software. |