| CTRI Number |
CTRI/2024/07/071445 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparative, Double blinded study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound assisted Optic nerve sheath diameter in Laparoscopic cholecystectomy patients at low versus standard pressure pneumoperitoneum |
|
Scientific Title of Study
|
Effect of low versus standard pressure pneumoperitoneum on intracranial pressure using ultrasound assisted Optic nerve sheath diameter in laparoscopic cholecystectomy under General Anaesthesia |
| 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 Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesiology and Intensive care, Government Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesiology and Intensive care, Government Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Khetarpal |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesiology and Intensive care, Government Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815654332 |
| Fax |
|
| Email |
rkhetarpal9@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Amritsar-143001, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Dev Hospital Amritsar Punjab India |
| Address |
Department of Anaesthesiology and Intensive care, Government Medical College, Amritsar-143001 (Punjab), India |
| 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 Jagtaran Singh |
Guru Nanak Dev Hospital, Amritsar |
Department of Anaesthesiology and Intensive care, Government Medical College, Amritsar
Amritsar
PUNJAB |
09814305937
jagtaransingh58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group L (Low)- Low pressure of 8-10 mm Hg |
At low pressure range (8-10 mmHg) for creation of pneumoperitoneum used for surgery we will do ultrasonographic estimation of Optic nerve sheath diameter (ONSD) in 50 patients in this group. We will try to find relation between set pneumoperitoneum pressures and its effect on ONSD. Other haemodynamic parameters like heart rate, Mean arterial pressure will also be monitored at defined time intervals. |
| Intervention |
Group S (Standard)- Standard pressure of 12-16 mm Hg |
At standard pressure range (12-16 mmHg) for creation of pneumoperitoneum used for surgery we will do ultrasonographic estimation of Optic nerve sheath diameter (ONSD) in 50 patients in this group. We will try to find relation between set pneumoperitoneum pressures and its effect on ONSD. Other haemodynamic parameters like heart rate, Mean arterial pressure will also be monitored at defined time intervals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years
2.Gender (both males and females)
3.American Society of Anaesthesiologists (ASA) Grade I-II
4.Elective laparoscopic cholecystectomy surgery under general anaesthesia
5.Duration of surgery less than 2 hours
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to take part in study and refusing for consent
2.Patients with ASA Grade III and IV
3.Patients with Mallampatti grading III and IV or difficult airway
4.Patients with prior history of orbital trauma
5.Past history of neurological diseases
6.Patients with history of glaucoma
7.Surgical duration beyond 2 hours
8.Known history of Chronic Obstructive Pulmonary Disease (COPD)
9.History of heart disease
10.Previous lung surgery
11.Patients who will have intraoperative haemodynamic instability
12.Patients who will require conversion to open cholecystectomy procedure intraoperatively
13.Patients with etco2 value greater than 45 mmhg,plateau pressure above 30 cm h20 will be excluded from our study
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OPTIC NERVE SHEATH DIAMETER:- Measured through ultrasound assistance in both eyes. Primary goal is to compare the impact of Low versus Standard pressure pneumoperitoneum on Intracranial pressure using ultrasound assisted Optic nerve sheath diameter in patients undergoing elective laparoscopic cholecystectomy |
Optic nerve sheath diameter will be measured at following time intervals:-
1.Before Induction of Anaesthesia
2.5 minutes after induction in supine position
3.10 minutes post pneumoperitoneum
4.10 minutes after 30-degree reverse Trendelenberg positioning
5.At every 20 minutes interval intraoperatively
6.After returning to supine position without pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Haemodynamic changes:- Comparison of vital signs (Heart rate, Mean Arterial pressure) between the two groups at low versus standard pressure pneumoperitoneum
2.To observe Complications, if any |
Heart rate, Mean arterial pressure will be monitored:-
1.At the time of Induction
2.At the time of CO2 insufflation
3.While patient is kept in Reverse Trendelenberg position
4.Intraoperatively
5.In supine position after exsufflation of gas |
|
|
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)
|
07/08/2024 |
| 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="0"
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
|
Optic nerve sheath diameter measurement is an indirect measurement of Intracranial pressure and can give us information about the intracranial pressure changes during laparoscopic surgery. Optic nerve sheath diameter using ultrasound is a relatively newer modality. Various pressures of pneumoperitoneum can have varied effects on haemodynamic parameters and we are going to compare the effects between two groups through our study. This will be a comparative, double blinded study which will be conducted in Guru Nanak Dev Hospital, Amritsar after taking informed consent in patient’s vernacular language. This study will be conducted on 100 patients aged 18-65 years of either sex, of ASA grade I-II, scheduled to undergo elective laparoscopic cholecystectomy surgery under general anaesthesia. Optic nerve sheath diameter measurements will be done with the help of ultrasound machine high frequency linear probe at different time intervals in both eyes during the course of surgery and we will try to find relation between set pneumoperitoneum pressures and its effect on optic nerve sheath diameter at various time intervals. Other haemodynamic parameters will be measured accordingly. The data thus obtained will be analyzed and compared statistically.
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