FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/05/008470 [Registered on: 03/05/2017] Trial Registered Prospectively
Last Modified On: 07/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Simpler and less invasive device to give general anesthesia to children undergoing laparoscopic surgery 
Scientific Title of Study   A prospective observational study to assess the effectiveness and safety of second generation supraglottic airway devices in laparoscopic surgeries in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakhee Goyal 
Designation  Professor (Anaesthesia) 
Affiliation  Army Hospital R and R 
Address  Department of Anesthesia and Critical care Army Hospital R and R Delhi
Department of Anesthesia and Critical care Army Hospital R and R Delhi
South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakhee Goyal 
Designation  Professor (Anaesthesia) 
Affiliation  Army Hospital R and R 
Address  Department of Anesthesia and Critical care Army Hospital R and R Delhi
Department of Anesthesia and Critical care Army Hospital R and R Delhi
South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rakhee Goyal 
Designation  Professor (Anaesthesia) 
Affiliation  Army Hospital R and R 
Address  Department of Anesthesia and Critical care Army Hospital R and R Delhi
Department of Anesthesia and Critical care Army Hospital R and R Delhi
South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia and Critical care Army Hospital Research and Referral Delhi-110010 India 
 
Primary Sponsor  
Name  Army Hospital Research Referral New Delhi India 
Address  Department of Anaesthesia and Critical care Army Hospital (Research & Referral), New Delhi, India  
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 
Rakhee Goyal  Army Hospital Research and Referral  Department of Anaesthesia and Critical care Army Hospital (Research & Referral), New Delhi, India
South West
DELHI 
7798225637
01125684096
rakheegoyalkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Hospital Research and Referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children scheduled for routine elective laparoscopic surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Supraglottic devices (i-gel, proseal LMA)   Use of supraglottic devices (i-gel, proseal LMA) that are routinely used for ventilation during general anesthesia both in adults and children in place of endotracheal tube. These have been extensively used in laparoscopic surgeries in adults but in children the literature is still limited though with very promising results. In this study i-gel or Proseal LMA will be used for children undergoing routine elective laparosopic surgeries. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All patients scheduled for elective laparoscopic surgery in a tertiary care pediatric surgery center and their parents consenting for their children to participate in the study protocol will be included in the study.
ASA I-II
BMI 20-30 kg/m2
 
 
ExclusionCriteria 
Details  Respiratory tract infection
Inadequate fasting as per standard fasting guidelines
Difficult airway
Emergency surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oro-pharyngeal seal pressure (OSP) of the supraglottic device   2 min after insertion,
10 min after creation of pneumoperitoneum,
every 30 min thereafter till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
heart rate, non-invasive blood pressure, SpO2, ECG, Peak airway pressure, respiratory rate, tidal volume will be continuously monitored and noted   every 30 min from the start of anesthesia 
sore throat, hoarseness of voice, oral bleeding  At extubation
2 h after extubation
6 h after extubation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/12/2017 
Estimated Duration of Trial   Years="0"
Months="6"
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  

Second generation supraglottic airway devices (SAD) have been successfully used for laparoscopic surgeries in adults as they provided good airway seal and the presence of gastric drain port added safety against gastric regurgitation. There was a limited availability of these devices pediatric sizes till a few years back but now different brands of second generation SADs such as Proseal LMA, LMA Supreme, i-gel, Ambu Aura Gain and LTS II are being marketed globally. They are sized on body weight basis as 1, 1.5, 2, 2.5 and 3 for children with essentially the same design as adults. These devices have been effectively used in non-laparoscopic surgeries in children and found to have good sealing pressures. However, there is limited literature of their use in children for laparoscopic surgeries.

In our institute, laparoscopic surgeries such as inguinal herniotomy, pyeloplasty, cholecystectomy, nephrectomy, splenectomy are routinely performed in the pediatric age group. We have been successfully using SADs like i-gel and Proseal LMA for surgeries of shorter duration like herniotomies. This study is designed to assess the feasibility, effectiveness, and safety of second generation SADs for positive pressure ventilation in laparoscopic surgeries in children.

Aims and objectives

To prospectively assess the feasibility, effectiveness, and safety of second generation SADs for positive pressure ventilation in laparoscopic surgeries in children

Methodology

Written informed consent will be taken from all parents of children who meet the inclusion criteria. Standard fasting guidelines will be followed. The children will be given oral triclofos 70 mg/kg in the pre-operative room and they will be taken to the theater suite when they are sedated or co-operative. Sevoflurane 8% in 100% oxygen will be given by face mask, and an intravenous (iv) access will be secured. Fentanyl 2μg/kg and atracurium 0.5 mg/kg will be given and sevoflurane reduced to 4%. When the jaw is fully relaxed, an appropriate sized SAD will be inserted. It will be secured in place by an adhesive tape. A suction catheter will be inserted through the gastric channel of the SAD. Oro-pharyngeal seal pressure (OSP) of the device will be checked after 2 min. If the OSP is <25 mm Hg, the device will be removed and intubated with an endotracheal tube. The data of cases in which OSP is >25 mm Hg will be analysed for the study.

The patient will be ventilated on pressure control mode, I:E ratio 1:2, O2:air 50:50 at a pressure and rate so as to generate at least 8 ml/kg tidal volume and etCO2 < 45 mmHg. The heart rate, non-invasive blood pressure, SpO2, ECG, Peak airway pressure, respiratory rate, tidal volume will be continuously monitored and noted every 30 min. Ten min after creation of the pneumoperitoneum, the OSP will be measured again.

The patient will be maintained on sevoflurane 1 MAC, atracurium, and intravenous opioids or regional technique as appropriate (caudal/lumbar epidural/TAP block). At the end of the surgery, the patient will be reversed with neostigmine 70 mg/kg and glycopyrollate 10μg/kg. The SAD will be removed once the patient is breathing spontaneously and inspected for presence of any blood on the device.

The patient will be followed up for 6 hr and any adverse effect like sore throat, hoarseness of voice, oral bleeding, vomiting will be noted.


 
Close