| CTRI Number |
CTRI/2019/03/017921 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the safety of two airway equipments like Baska mask and Endotracheal tube during key hole surgeries |
|
Scientific Title of Study
|
Safety and efficacy of Baska mask as an alternative airway device to endotracheal tube in patients undergoing laparoscopic surgeries under controlled ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulak Tosh |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
9199199992 |
| Fax |
06122451109 |
| Email |
pulaktosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pulak Tosh |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
9199199992 |
| Fax |
06122451109 |
| Email |
pulaktosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pulak Tosh |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
9199199992 |
| Fax |
06122451109 |
| Email |
pulaktosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
phulwarisharif,
Patna |
| 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 |
| Dr Pulak Tosh |
All India Institute of Medical Sciences |
Department of Anaesthesiology,
Phulwarisharif,
Patna
BIHAR |
9199199992
06122451109
pulaktosh@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: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baska mask |
The airway of one group of patients will be secured with Baska mask |
| Comparator Agent |
Cuffed endotracheal tube |
The airway of one group of patients will be secured with cuffed endotracheal tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic surgeries under general anaesthesia
American Society of Anesthesiologists physical status 1-2
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Patients with renal dysfunction, G6PD deficiency
Patients on rate controlling medications, steroids, regular antacids, MAO inhibitors, antidepressants
Preoperative sore throat, hiatus hernia, obesity, pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to assess the haemodynamic stress response to insertion of Baska mask as compared to endotracheal intubation in patients undergoing laparoscopic surgeries. |
Before induction, 1, 3, 5 and 10 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of time and attempts taken to secure airway, evidence of pulmonary aspiration of gastric contents at end of surgery and incidence and severity of Postoperative sore throat, hoarseness of voice and cough in these patients. |
2, 6, 12 and 24 h |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/03/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Nothing yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients will receive GA as per a generalized protocol. Airway will be secured in Group B using Baska mask and with cuffed endotracheal tube in Group T. Difference in the hemodynamic changes during airway securing will be assessed. We will aiso compare number of attempts taken to secure airway, evidence of pulmonary aspiration, incidence and severity of postoperative sore throat and hoarseness of voice. |