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
|
|
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
|
|
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.
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