| CTRI Number |
CTRI/2023/05/052985 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Optic Nerve Sheath Diameter using ultrasound for indirect assessment of intracranial pressure in laparoscopic cholecystectomy patients following intubation or insertion of I-Gel |
|
Scientific Title of Study
|
A prospective study to evaluate and compare the optic nerve sheath diameter (ONSD) assessed by ultrasound following tracheal intubation or insertion of I-Gel in patients undergoing laparoscopic cholecystectomy under general anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeru |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC, Kangra at Tanda |
| Address |
Department of Anesthesiology, Dr RPGMC, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9729405510 |
| Fax |
|
| Email |
neer5897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Professor |
| Affiliation |
Dr RPGMC, Kangra at Tanda |
| Address |
Department of Anesthesiology, Dr RPGMC, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeru |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC Tanda, Kangra |
| Address |
Department of Anesthesiology, Dr RPGMC, Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9729405510 |
| Fax |
|
| Email |
neer5897@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Department of Anesthesiology, Dr RPGMC Kangra at Tanda, 176001 |
| 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 |
| Neeru |
Dr RPGMC Kangra at Tanda |
Department of Anesthesia
Kangra
Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9729405510
neer5897@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Kangra at Tanda, Himachal pradesh, India-176001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surgery/Anesthesia |
Inclusion and exclusion criteria
will be as described above.
Laparoscopic cholecystectomy
will be performed after
General anesthesia, will be performed
using 2 mg/kg dose of propofol,
and
Atracurium (0.5mg/kg) and airway will be secured with endotracheal
intubation/ Igel insertion,
anesthesia will be maintained
using O2/N2O/Isoflurane.
US system (MicroMaxx ultrasound system, SonoSiteInc, Bothell, Washington, USA) with a 13–6 MHz, 38 mm broadband linear array transducer.will be used
for measurement of ONSD. For
each subject 6 measurements of ONSD
will be taken along with hemodynamics of patient. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients between the age group 25 to 60 years
2. ASA class 1-2
3. BMI 18.5-29.9 kg/m2
4. Mallampati 1 or 2 |
|
| ExclusionCriteria |
| Details |
1. Patients with Severe Cardiovascular or Respiratory disorders, Diabetes, Hypertension
2. Obesity (BMI>30kg/m2)
3. Difficult airway
4. History of sleep apnea
5. Eye surgery, Orbital trauma
6. Anticipated duration of surgery >2 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in ONSD |
T0- before induction of anesthesia, T1- 5 min after intubation/Igel insertion in supine position, T2- 10 min post pneumoperitoneum, T3- 10 min after 30 degree reverse Trendelenburg positioning, T4- pneumoperitoneum and reverse Trendelenburg, T5- 5 min after supine position without pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, Mean arterial blood pressure, Peak airway pressure, EtCO2 |
as in primary outcome |
| postoperative nausea and vomiting |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy is the gold standard for gallstone and gallbladder diseases. After pneumoperitoneum, changes maybe observed in intrathoracic, intraabdominal, intracranial pressures. To measure intracranial pressure technique like orbital sonography with optic nerve sheath diameter measurement has been developed. This trial is ’evaluation and comparison of the Optic Nerve Sheath Diameter (ONSD) assessed by ultrasound following tracheal intubation or insertion of I-Gel’. We will include the patients aged from 25 to 60 years of either sex with gall stone disease undergoing laparoscopic cholecystectomy under general anesthesia. |