| CTRI Number |
CTRI/2024/05/067818 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing effect of different flow of anaesthesia and pneumoperitoneum on intracranial pressure by measuring optic nerve sheath diameter using ultrasound machine during laparoscopic cholecystectomy surgery. |
|
Scientific Title of Study
|
Comparison of fresh gas flow of anaesthesia and pneumoperitoneum on intracranial pressure as measured by optic nerve sheath diameter during laparoscopic cholecystectomy: a randomised clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Rautela |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Dept. of Anaesthesia,All India Institute of Medical Sciences , Kunraghat, Gorakhpur, Uttar Pradesh, India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8755727228 |
| Fax |
|
| Email |
rautelariya19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Kabi |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Deptt. of Anaesthesia, All India Institute of Medical Sciences Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9810205883 |
| Fax |
|
| Email |
ankitakabi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Rautela |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Dept. of Anaesthesia,All India Institute of Medical Sciences , Kunraghat, Gorakhpur, Uttar Pradesh, India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8755727228 |
| Fax |
|
| Email |
rautelariya19@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh, India - 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Riya Rautela |
| Address |
Dept. of Anaesthesia, All India Institute of Medical Sciences, Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh-273008 |
| 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 Riya Rautela |
All India Institute of Medical Sciences, Gorakhpur |
OT Complex, Dept. of Anaesthesia, All India Institute of Medical Sciences Gorakhpur, Kunraghat, Gorakhpur, Uttar Pradesh, India - 273008
Gorakhpur
UTTAR PRADESH |
8755727228
rautelariya19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Humans Ethics Committee, All India Institute of Medical Sciences, Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (3) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (4) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (5) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (6) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of fresh gas flow of anaesthesia and pneumoperitoneum on intracranial pressure as measured by optic nerve sheath diameter during laparoscopic cholecystectomy. |
Comparison of fresh gas flow of anaesthesia and pneumoperitoneum on intracranial pressure as measured by optic nerve sheath diameter during laparoscopic cholecystectomy and observations will be made till 10 minutes post desufflation of pneumoperitoneum. |
| Comparator Agent |
Group - LL |
Patient will recieve low flow (0.75L/min) anaesthesia and surgery will be conducted with low pressure (8-10mmHg) pneumoperitoneum and observations will be made till 10 minutes post desufflation of pneumoperitoneum. |
| Comparator Agent |
Group - LS |
Patient will recieve low flow (0.75L/min) anaesthesia and surgery will be conducted with standard pressure (12-16mmHg) pneumoperitoneum and observations will be made till 10 minutes post desufflation of pneumoperitoneum. |
| Comparator Agent |
Group - NL |
Patient will recieve normal flow (1.5L/min) anaesthesia and surgery will be conducted with low pressure (8-10mmHg) pneumoperitoneum and observations will be made till 10 minutes post desufflation of pneumoperitoneum. |
| Comparator Agent |
Group - NS |
Patient will recieve normal flow (1.5L/min) anaesthesia and surgery will be conducted with standard pressure (12-16mmHg) pneumoperitoneum and observations will be made till 10 minutes post desufflation of pneumoperitoneum. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group 18-65
years posted for elective surgery.
2. Belonging to ASA Grade I and II.
3. Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient unwilling to participate in the study.
2. Pregnant female.
3. Previous eye surgery.
4. Head and neck surgery.
5. Previous orbital trauma or surgical history.
6. Intracranial space covering lesions with high
ICP.
7. Chronic kidney disease.
8. Cirrhosis with ascitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in ONSD at 30 minutes after pneumoperitoneum among patients undergoing laparoscopic cholecystectomy with varying flow and varying intraabdominal pressure. |
30 minutes after creation of pneumoperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the change in ONSD at post induction, 15 mins after pneumoperitoneum in supine position and 10 mins after desufflation.
2.To assess the change in ONSD with low flow and normal flow anaesthesia.
3.Correlation of post operative nausea vomiting and headache with change in ONSD.
4.To assess the change of hemodynamics like MAP, HR with PP, and flow of anaesthesia.
5.To assess the change of Peak airway pressure with PP and flow of anaesthesia.
6.To assess the change of ETCO2 with PP and flow of anaesthesia. |
Immediately after induction, 15 mins after pneumoperitoneum in supine position and 10 mins after desufflation. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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
|
This
study is a prospective randomized controlled trial, primarily comparing the change in ONSD at different time intervals with
varying flow and varying intraabdominal pressure in 112 patients undergoing laparoscopic
cholecystectomy at AIIMS Gorakhpur. Secondary objectives will be to assess the
change of hemodynamics(MAP, HR), change of ETCO2 and change of Peak airway
pressure with pneumoperitoneum and flow of anaesthesia. In addition to this the
correlation between post-operative nausea, vomiting and headache with change in
ONSD will be assessed. Safety outcome will be recording and reporting of
adverse events.
|