| CTRI Number |
CTRI/2024/06/069637 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out if having trouble putting in breathing tubes is related to having trouble putting in feeding tubes during gallbladder surgery under general anaesthesia. |
|
Scientific Title of Study
|
To find any correlation between difficult intubation and difficult orogastric tube insertion in patients undergoing
laparoscopic cholecystectomy under general anaesthesia A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Sharma |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College kangra at Tanda |
| Address |
Department of Anaesthesia Dr
Rajendra Prasad Government Medical College Kangra at TANDA
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7018200891 |
| Fax |
|
| Email |
sharma.vivek108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Bhandari |
| Designation |
Associate Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College kangra at Tanda |
| Address |
Department Of Anaesthesia Dr Rajendra Prasad Government Medical College Kangra at TANDA
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7018200891 |
| Fax |
|
| Email |
dr.bhandari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Sharma |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC Kangra at TANDA |
| Address |
Department of Anaesthesia Dr RPGMC Kangra at TANDA
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7018200891 |
| Fax |
|
| Email |
sharma.vivek108@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government medical college Kangra at TANDA |
| Address |
Department of Anaesthesiology Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| 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 Vivek sharma |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
Department of Anaesthesia
Operation Theatre complex third floor
Kangra
HIMACHAL PRADESH |
7018200891
sharma.vivek108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad Government Medical College Kangra at Tanda |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1-2
BMI 18.5-29.9
Undergoing elective laparoscopic cholecystectomy under general anaesthesia requiring orogastric tube insertion |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patient with ASA 3-4.
deformity of chin, pharynx or larynx.
Patient planned for fibreoptic intubation in view of anticipated difficult intubation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is an observational study to find any relation between difficult intubation and difficult orogastric tube insertion in patient undergoing laparoscopic cholecystectomy under general anaesthesia. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find any correlation between difficult intubation by IDS & difficult orogastric tube insertion. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included sharma.vivek108@gmail.com).
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients enrolled in the study will have the anesthetic procedure explained and give written consent. Before surgery, a case record form will be completed for each patient. Patients will fast for at least 8 hours prior and receive premedication with Alprazolam 0.25mg and Ranitidine 150 mg at 6:00 am on the surgery day. Upon arrival in the operating theatre, standard monitoring and an intravenous line will be set up. Baseline parameters will be recorded.
Premedication with Midazolam 0.03 mg/kg and Fentanyl 2ug/kg will be administered, followed by pre-oxygenation. Induction will involve Propofol 1.5 -2mg/kg and atracurium 0.5mg/kg as a muscle relaxant. The laryngoscope will be used for direct laryngoscopy and endotracheal intubation will be performed, documenting Cormack -lehane grading and Intubation difficulty score.
After intubation, a refrigerated orogastric tube will be inserted through the oral route. Multiple attempts will be made using different techniques if initial insertion fails. Final confirmation of tube placement will be done via auscultation. Success rates and any adverse effects will be documented, and the orogastric tube will be inspected for blood post-surgery. |