| CTRI Number |
CTRI/2011/11/002168 [Registered on: 25/11/2011] Trial Registered Prospectively |
| Last Modified On: |
30/12/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two airway devices i-gel vs Laryngeal mask airway-unique on easiness of insertion during general anaesthesia |
|
Scientific Title of Study
|
Comparison between two supraglottic airway devices i-gel vs Laryngeal mask airway-unique on easiness of insertion during general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Raj M |
| Designation |
Junior resident |
| Affiliation |
Government Medical College , Thiruvananthapuram |
| Address |
Dr. Arun Raj M,
Junior resident,
Department of Anaesthesia,
Medical College,
Thiruvananthapuram,
Kerala.
Akshara,
T.C 7/791,
Ulloor Bhasi Nagar,
Medical College P.O,
Thiruvananthapuram - 11,
Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9495011364 |
| Fax |
|
| Email |
definitelyarun@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RS Usha Devi |
| Designation |
Professor |
| Affiliation |
Government Medical College , Thiruvananthapuram |
| Address |
Head of Department,
Department of Anaesthesia,
Medical College,
Thiruvananthapuram,
Kerala.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
k_rajm@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Raj M |
| Designation |
Junior resident |
| Affiliation |
Government Medical College , Thiruvananthapuram |
| Address |
Dr. Arun Raj M,
Junior resident,
Department of Anaesthesia,
Medical College,
Thiruvananthapuram,
Kerala.
Akshara,
T.C 7/791,
Ulloor Bhasi Nagar,
Medical College P.O,
Thiruvananthapuram - 11,
Kerala
KERALA
695011
India |
| Phone |
9495011364 |
| Fax |
|
| Email |
definitelyarun@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College,
Thiruvananthapuram. |
|
|
Primary Sponsor
|
| Name |
Government medical college Thiruvananthapuram |
| Address |
Department of Anaesthesia,
Government Medical College,
Thiruvananthapuram. |
| 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 Arun Raj M |
Government Medical College , Thiruvananthapuram |
Department of Anaesthesia,
Government Medical College ,
Thiruvananthapuram.
Thiruvananthapuram
KERALA |
9495011364
definitelyarun@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Medical College , Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i-gel supraglottic airway device |
After an adequate depth of anesthesia and muscle relaxation ,the i-gel size 3, 4 or 5 is inserted according to the manufacturers instructions. Size selection of the i-gel depends on patient weight: size 3 is used for patients 50 kg, size 4 is used for those between 50 and 90 kg, and size 5 is used for those over 90 kg in weight.Propofol infusion with O2:N2O mixture in a ratio of 2:4 is used for maintenance of anaesthesia during data collection. At the end of the operation, anesthetic agents are discontinued, allowing smooth recovery of consciousness. The device is removed after the patient regains consciousness spontaneously and responds to verbal command to open the mouth. |
| Comparator Agent |
Laryngeal Mask Airway-Unique supraglottic airway device |
After an adequate depth of anesthesia and muscle relaxation ,the LMA is inserted according to the manufacturers instruction manual. For LMA-U ,we follow a weight based algorithm recommended by the manufacturers: size 3 is used for patients 50 kg, size 4 is used for those between 50 and 70 kg, and size 5 is used for those over 70 kg. The cuff of the LMA-U is inflated to two-thirds of the maximum recommended volume as this usually provides most effective seal. Therefore size 3, 4 and 5 LMA-U will be inflated with 13, 20 and 26 ml of air respectively. Propofol infusion with O2:N2O mixture in a ratio of 2:4 is used for maintenance of anaesthesia during data collection. At the end of the operation, anesthetic agents are discontinued, allowing smooth recovery of consciousness. The device is removed after the patient regains consciousness spontaneously and responds to verbal command to open the mouth. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 - Healthy patient without organic, biochemical, or psychiatric disease
ASA 2 - A patient with mild systemic disease, e.g., mild asthma or well-controlled hypertension. No significant impact on daily activity. Unlikely to have an impact on anesthesia and surgery |
|
| ExclusionCriteria |
| Details |
ASA 3- Significant or severe systemic disease that limits normal activity, e.g., renal failure on dialysis or class 2 congestive heart failure. Significant impact on daily activity. Probable impact on anesthesia and surgery
ASA 4-Severe disease that is a constant threat to life or requires intensive therapy, e.g., acute myocardial infarction, respiratory failure requiring mechanical ventilation. Serious limitation of daily activity. Major impact on anesthesia and surgery
ASA 5-Moribund patient who is equally likely to die in the next 24 hours with or without surgery
ASA 6-Brain-dead organ donor
Duration of surgery more than 2 hours
Emergency surgery
Surgery in positions other than supine
Pathology of neck or upper repiratory tract
Potential difficult intubation
Mouth opening less than 2.5 cms
Pregnant women
BMI more than 35 kg/m2
Patients with reported hypersensitivity for one or more medications and latex
Increased risk of aspiration ( hiatus hernia , gastro esophageal reflux , full stomach ) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of insertion |
Time from picking up the device to first successful breath made by manual ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reposition attempts |
Manipulations allowed: gentle pushing or pulling of the device, chin lift, jaw thrust, head extension, or neck flexion. |
| Number of insertion attempts |
A failed attempt is defined as removal of the device from the mouth before re-insertion. |
| Sealing pressure (airway leak pressure) |
Measuring the minimal airway pressure at which an audible gas leak occurred using a stethoscope placed just lateral to thyroid cartilage. |
| Hemodynamic effects |
Pulse Rate , Blood Pressure (systolic , diastolic & mean) , Oxygen saturation are monitored and recorded. |
| Leak volumes |
The difference between inspired tidal volume (ITV) and expired tidal volume (ETV) |
| Perioperative Complications |
Bronchospasm ,Laryngospasm and coughing , trauma , postoperative sore throat (constant pain, independent of swallowing), dysphagia (difficulty or pain with swallowing), dysphonia (difficulty or pain with speaking) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Randomized controlled trial to be conducted at the OTs of Government medical college Thiruvananthapuram , comparing the easiness of insertion of two supraglottic airway devices - i-gel and LMA-unique in patients who undergo surgery under general anaesthesia. ASA 1 & 2 patients in the age group 20 - 60 years selected after a thorough pre anaesthetic assessment and informed consent will be randomized into two groups. General anaesthesia will be performed after all the necessary preparations , intravenous access and monitors. Premedication with midazolam , fentanyl , metoclopramide and glycopyrrolate ( in the premedicant doses ) is followed by preoxygenation and induction with propofol . Muscle relaxation is achieved with a single dose of 2mg/kg succinyl choline . At an adequate depth , 1st group patients’ airway is secured with an i-gel while the 2nd group receives LMA-unique (according to the manufacturer recommended size selection and instructions). Ventilation is checked to be optimal. maintenance is with nitrous oxide - oxygen in ratio 4:2 and infusion of propofol. Time taken to insert device , insertion and reposition attempts , sealing pressures , leak volumes are noted and hemodynamic parameters are monitored. At the end of the surgery , the device is removed when the patients regain consciousness and can respond to verbal commands. Airway complications are noted and postoperative complications are sought for and managed. References 1. Brimacombe , Keller , Morris , Mecklem . Comparison of disposable with reusable LMA in paralyzed adult patients . Anaesthesia analgesia 1998; 87:921-4 2. Uppal , Gangaiah , Fletcher , Kinsella . Randomized crossover comparison between i-gel and LMA-unique in anaesthetized paralysed patients. BJA 2009;103(6):882-885 3. Helmy , Atef , El-Taher , Henidak. Comparative study between i-gel and classic LMA in anaesthetised spontaneously ventilated patients. Saudi journal of anaesthesia 2010; volume 4,issue 3:131-136
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