| CTRI Number |
CTRI/2025/09/094916 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Two Different Ways of Placing a Breathing Tube and their Effect on the Eye During Gallbladder Surgery
|
|
Scientific Title of Study
|
Comparison of video laryngoscope with direct laryngoscope for the effect of laryngoscopy and intubation on optic nerve sheath diameter in adult patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santhosh Kumar A |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
7010899221 |
| Fax |
|
| Email |
santho2k8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Saigal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Saigal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Critical Care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
India
110029 |
|
|
Primary Sponsor
|
| Name |
Santhosh Kumar A |
| Address |
Post graduate resident,
Department of Anaesthesiology and critical care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
Ansari Nagar West, New Delhi
India
110029 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Deepti Saigal |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Operation theatre 1,
Main operation theatre complex
Department of anaesthesiology and intensive care,
Vardhman Mahavir Medical College and Safdarjung Hospital,
Ansari Nagar West, New Delhi, India 110029
South
DELHI |
8595611255
deeptisaigal21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laryngoscopy and intubation using direct laryngoscope |
Preoxygenation with 100% o2
Fentanyl 2 mcg/kg iv
Propofol 2 mg/kg iv
Vecuronium 0.1mg/kg iv
Inhalation with n2o and isoflurane
Duration : less than 5 mins
|
| Intervention |
Laryngoscopy and intubation using video laryngoscope |
Preoxygenation with 100% o2
Fentanyl 2 mcg/kg iv
Propofol 2 mg/kg iv
Vecuronium 0.1mg/kg iv
Inhalation with n2o and isoflurane
Duration :less than 5 mins
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, neurological conditions, patients with history of eye infections and diabetic retinopathy, history of intracranial or intraocular surgery |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Optic nerve sheath diameter |
1. At baseline
2. 1,3 & 5 minutes after intubation
3. 10 and 60 minutes after insufflation of pneumoperitoneum
4.10 minutes after desufflation of pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Systolic Blood Pressure
2. Diastolic Blood Pressure
3. Mean Arterial Pressure
4. Oxygen Saturation |
1. At baseline
2. 1,3 & 5 minutes after intubation
3. 10 and 60 minutes after insufflation of pneumoperitoneum
4.10 minutes after desufflation of pneumoperitoneum |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/12/2025 |
| 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 - NO
|
|
Brief Summary
|
To compare video laryngoscope with direct laryngoscope for the effect of laryngoscopy and intubation on optic nerve sheath diameter in adult patients undergoing laparoscopic cholecystectomy. Primary objective: To compare C-MAC video laryngoscope with direct laryngoscope for the effect on Optic Nerve Sheath Diameter (ONSD) measured by trans ocular ultrasound at 1,3 and 5 minutes after laryngoscopy and intubation in adult patients undergoing laparoscopic cholecystectomy Secondary objectives: A. To compare C-MAC video laryngoscope with direct laryngoscope for the effect on Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) & Mean arterial pressure (MAP) at 1,3 &5 minutes post laryngoscopy and intubation. B. To measure optic nerve sheath diameter (ONSD) by trans ocular ultrasound, Heart Rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) & Mean arterial pressure (MAP) at 1. 10 & 60 minutes after insufflation of pneumoperitoneum 2. 10 minutes after desufflation of pneumoperitoneum in supine position. |