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CTRI Number  CTRI/2016/04/006811 [Registered on: 08/04/2016] Trial Registered Retrospectively
Last Modified On: 06/04/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   I-gel supra-glottic airway device use in laparoscopic surgery 
Scientific Title of Study   To determine the feasibility and safety of using I-gel supra-glottic airway device for low-flow anesthesia for laparoscopic surgery 
Trial Acronym  igel 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asma Murtaza Khan 
Designation  Senior Resident Anaesthesiology 
Affiliation  Saket City Hospital 
Address  Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
South
DELHI
110017
India 
Phone    
Fax    
Email  dr.asmakhan.sgrh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mukul Chandra Kapoor 
Designation  Director Anesthesia 
Affiliation  Saket City Hospital 
Address  Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
South
DELHI
110017
India 
Phone    
Fax    
Email  mukulanjali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mukul Chandra Kapoor 
Designation  Director Anesthesia 
Affiliation  Saket City Hospital 
Address  Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017

DELHI
110017
India 
Phone    
Fax    
Email  mukulanjali@gmail.com  
 
Source of Monetary or Material Support  
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 
 
Primary Sponsor  
Name  Saket City Hospital 
Address  Press Enclave Road, Saket, Delhi 110017 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Asma Murtaza Khan  Saket City Hospital  Department of Anesthesia, Saket City Hospital, 1st Floor, Press Enclave Road, Saket Delhi 110017
South
DELHI 
9310891881

dr.asmakhan.sgrh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saket City Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cases for laparoscopic surgeries up to 2 hours duration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal tube tracheal intubation  Airway will be secured by an appropriate size oral endotracheal tube following administration of a neuromuscular blocker 
Intervention  Igel supraglottic airway  Airway will be secured by an appropriate size I-gel following administration of a non-depolarizing muscle relaxant.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age >18years
2.Elective Laparoscopic abdominal surgery with up to 2 hours duration anesthesia delivery.
3.ASA 1-3
 
 
ExclusionCriteria 
Details  1. Patients undergoing a concomitant procedure.
2. Pulmonary disease and ASA 4.
3. Hypersensitivity to one or more medications.
4. Previous thoracic surgeries.
5. Anticipated difficult airway.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
: To determine the lowest fresh gas flow delivery at which there is no clinical leak as compared to an endotracheal tube, which is considered as the gold standard  The parameters will be monitored and recorded every minute along with reduction of flows till 400 ml/min and thereafter every 15 min till 2 hours after which the study will be terminated.  
 
Secondary Outcome  
Outcome  TimePoints 
•To determine safety of use of low flow technique in terms of oxygen saturation.
•To evaluate the ease of placing the oro/naso gastric tube
•To determine the incidence of adverse effects of the two devices
 
The parameters will be monitored and recorded every minute along with reduction of flows till 400 ml/min and thereafter every 15 min till 2 hours after which the study will be terminated.  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/07/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

All patients would undergo a pre-anesthetic evaluation comprising of history, general physical and systemic examinations. All efforts will be focused on the identification of any comorbid diseases and their optimization before surgery. Preoperative investigations would be appropriately performed to guide and optimize perioperative management. All patients shall be kept fasting for at least 6 hours.
Patients will be allocated to two groups of 25 patients each by random computer draw.
Group A - Securing airway with I-gel supraglottic airway device.
Group B - Securing airway with endotracheal tube (ETT).
All patients will be administered general anesthesia for the procedure. A Drager Fabius Plus Anesthesia Machine will be used in all cases with a co-axial closed circuit breathing system. A standardized protocol for induction and maintenance of anesthesia will be followed which would comprise of intravenous fentanyl (1-2mcg/kg) followed by propofol (1.5-2mg/kg) for induction. Airway will be secured by an appropriate size oral ETT or I-gel following administration of a non-depolarizing muscle relaxant. The head end of the patient will be covered with drapes to facilitate blinding of the investigator. Anesthesia will be maintained with desflurane in oxygen and nitrous oxide titrated to maintain FiO2 of 0.5 at all times. A non-depolarizing muscle relaxant will be administered for maintenance of neuromuscular blockade during the surgical procedure. Standard volume control ventilation settings will be used in both groups with tidal volume of 8ml/kg, to maintain minute ventilation of 100ml/kg and end-tidal carbon dioxide (EtCO2) between 30-40 mm Hg.
Initially high fresh gas flows (FGF) of 6 l/min will be used to achieve desired expired concentration of anesthetic gases and then FGF reduced to 1000 ml/min. The time of initiation of a FGF of 1000ml/min will be considered as Time 0. FGF will then be reduced by 100 ml/min till the final goal of 400 ml/min total FGF is achieved, which will be recorded as a state of no clinical leak in the breathing system. The FGF will not be reduced below the above limit. The FGF will not be reduced in case of collapse of bellows, ventilation alarms or desaturation. An independent observer, unaware of the airway device used, will record all observations. The parameters will be monitored and recorded every minute along with reduction of flows till 400 ml/min and thereafter every 15 min till 2 hours after which the study will be terminated. The following parameters will be recorded:

  1. Heart rate
  2. Blood pressure
  3. Oxygen saturation
  4. End tidal Carbon dioxide
  5. Peak Airway pressure
  6. Loss of tidal volume (Set tidal volume - Delivered tidal volume)
  7. Total Flow delivered
  8. Changes in above parameters with change in position from supine to Trendelenberg or reverse Trendelenberg.

Efficiency of placing naso/oro-gastric tube will be noted along with gastric distension at the beginning and end of surgery. At the end of the procedure, neuromuscular blockade will be reversed and post extubation patient will be shifted to PACU for observation.
Patients will be followed up in PACU and 24 hours after surgery in wards to note complaints of sore throat (constant pain, independent of swallowing, dysphagia, pain with swallowing), sore jaw, dysphonia, numbness of tongue or oropharynx, blocked or painful ears, reduced hearing or neck pain.

Statistical Power: The power of the study was calculated based on the study by Uppal et al1 comparing I-gel with ETT using pressure controlled ventilation. To estimate the sample size a mean difference of 0.25 was considered to get clinically significant results between the two groups. The standard deviation value used was 0.05. Using a power of 80% and a significance value of 0.05 for a two-sample t-test comparing two groups a total of 24 patients per group would be needed.

 
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