CTRI Number |
CTRI/2022/07/044102 [Registered on: 18/07/2022] Trial Registered Prospectively |
Last Modified On: |
16/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparative study to see the gastric volume in two airway device groups |
Scientific Title of Study
|
Comparison between proseal laryngeal mask airway and endotracheal intubation in lower abdominal surgeries for perioperative gastric volume assessment and recovery of gastrointestinal function - a randomised control trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ranjay |
Designation |
Post Graduate Resident |
Affiliation |
AIIMS |
Address |
Department of Anesthesioloy, Level 6, Academic block, AIIMS, Rishikesh AIIMS, Vir Bhadra Marg, Rishikesh Dehradun UTTARANCHAL 249203 India |
Phone |
8750339538 |
Fax |
|
Email |
helloranjay918@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Bhavna Gupta |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Rishikesh |
Address |
Department of Anesthesiology, level 5, Academic block, AIIMS, Rishikesh
Dehradun UTTARANCHAL 249203 India |
Phone |
8527686660 |
Fax |
|
Email |
bhavna.kakkar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ranjay |
Designation |
Post Graduate Resident |
Affiliation |
AIIMS |
Address |
Department of anesthesiology, level 6, Academic Block, AIIMS, Rishikesh AIIMS, Vir Bhadra Marg, Rishikesh Dehradun UTTARANCHAL 249203 India |
Phone |
8750339538 |
Fax |
|
Email |
helloranjay918@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS rishikesh |
Address |
AIIMS, vir bhadra marg, Rishikesh |
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 |
Ranjay |
AIIMS Rishikesh |
OT complex, level 6, Academic block, AIIMS, vir bhadra marg, AIIMS rishikesh. Dehradun UTTARANCHAL |
8750339538
helloranjay918@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
nil |
nil |
Comparator Agent |
Proseal LMA vs Endotracheal tube |
Intra gastric pressure will be compared in proseal LMA vs Endotracheal tube at baseline, intra-operatively and immediate post operative period |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Age ≥ 18 years and ≤ 65 years.
2. BMI≤30 kg/m2
3. American Society of Anesthesiologists (ASA) grading I-II.
4. Posted electively for laparoscopic lower abdominal procedures
|
|
ExclusionCriteria |
Details |
1. Preoperative sore throat and/or hoarseness.
2. Known risk of gastric aspiration.
3. Mallam Pati grade 3 or 4.
4. Facial and upper airway abnormalities that make mask ventilation and tracheal intubation difficult.
5. Hiatus hernia.
6. Pregnant and breastfeeding females.
7. Anticipated difficult intubation
8. Full stomach
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Antral cross-sectional area, as measured by ultrasound |
time points(baseline, Immediately after induction, at 1 hour, at the end of surgery and 1 hour post surgery) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Vital parameters (Heart Rate, Systolic Blood Pressure, Diastolic BP, MAP, SpO2, ETCO2)and intra abdominal pressure
Ventilation parameters (TV, Leak Fraction, Leak Volume, Peak pressure, plateau pressure)
Time (in hour minutes) to tolerance of clear fluids
Time(in hour minutes) to tolerance of Light diet
Time (in hour minutes) to achieve first bowel movement or first flatus, whichever is earlier
Length of stay and days to discharge in patients
|
time points(baseline, Immediately after induction, at 1 hour, at the end of surgery and 1 hour post surgery) |
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
21/07/2022 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Before arrival to the operating room, the patient will be assessed preoperatively in preoperative room and gastric volume will be calculated using antral cross sectional area using ultrasound. Conduct of anesthesia Upon arrival to the operating room, the patient will be positioned supine and advanced multipara monitor, including electrocardiogram, blood pressure, and SpO2, to all the patients included in the study. All patients will be premedicated with midazolam 1mg.General anesthesia will be induced with Fentanyl 2µg/kg, Propofol 1-2.5mg/kg and Vecuronium 0.1mg/kg. Patients Will be mask ventilated for 3 min using the anaesthesia machine, with controlled ventilation set to a tidal volume of 7mLkg�’ 1, frequency of 12 -16 breaths per minute and an inspiratory:expiratory ratio of 1:2 to maintain an end tidal carbon dioxide of 35-45mmHg.Thereafter respective airway device will be inserted accordingly to the group assignment as follows- Group E (Endotracheal intubation) and Group P (ProSeal laryngeal mask airways).If satisfactory insertion of proseal LMA is not achieved with three attempts, or there is respiratory embarrassment, the patient will be intubated using direct laryngoscopy and will be excluded from study. The ventilation will be set to Volume control mode delivering air: oxygen mixture (2:1) at a frequency of 12-16breadths/min, TV of 7 ml/kg, Inspiratory:expiratory(I:E) ratio of 1:2, to maintain EtCO2 at 35-45 mm Hg, by adjusting the respiratory rate. Anesthesia will be maintained with Sevoflurane at a Minimum Alveolar Concentration (MAC) of 1.0 initially, and titrated further to keep the Mean arterial pressure and heart rate within ±20% of the baseline values. Muscle relaxation will be achieved with vecuronium 1 mg intermittently according to NMT monitoring. .The difference between inspired tidal volume (ITV) and ETV will be used to calculate leak volume (LV), i.e. LV=Inspired Tidal Volume – Expired Tidal Volume. The leak fraction is defined as leak volume divided by ITV (i.e. leak fraction=LV/ITV). At the end of surgery, anesthesia will be discontinued, Muscle relaxation will be reversed with neostigmine and glycopyrollate. The tracheal tube, ProSeal LMA, will be removed when the patient will be spontaneously breathing and able to open their mouth to command. Any blood staining on the laryngoscope, tracheal tube, or ProSeal LMA will also be documented. Patients and post-anaesthesia care unit nurses will be unaware of the airway device used. A single trained observer, who is blinded to the airway device used, will document post operative events at 2, 6, and 24 h after surgery. Patients will be asked if they had any of the following symptoms (yes/no): nausea, vomiting (at any time), sore throat (constant pain, independent of swallowing), dysphonia (difficulty speaking and pain on speaking), and dysphagia (difficulty or pain provoked by swallowing). Anaesthesia time will be from mask ventilation to removal of the airway device. Surgical time will be from incision to insertion of the last stitch. |