Simpler and less invasive device to give general anesthesia to children undergoing laparoscopic surgery

Completed

Conditions: Children scheduled for routine elective laparoscopic surgeries

Registration Number: CTRI/2017/05/008470

Lead Sponsor: Army Hospital Research Referral New Delhi India

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 prospectivelyassess 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 2Î¼g/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 10Î¼g/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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

Respiratory tract infection Inadequate fasting as per standard fasting guidelines Difficult airway Emergency surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Army Hospital Research and Referral
🇮🇳
West, DELHI, India
Army Hospital Research and Referral
🇮🇳West, DELHI, India
Rakhee Goyal
Principal investigator
7798225637
rakheegoyalkumar@gmail.com