| CTRI Number |
CTRI/2014/10/005124 [Registered on: 20/10/2014] Trial Registered Prospectively |
| Last Modified On: |
17/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare non invasive bedside tool for detection of raised pressure inside the head.
|
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Scientific Title of Study
|
Comparative evaluation of ONSD in patients undergoing laparoscopic cholecystectomy using low and standard pressures of gas insufflations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikas Saini |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia PGIMER SECTOR 12, Chandigarh, India |
| Address |
Department of Anaesthesia
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikas Saini |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia PGIMER SECTOR 12, Chandigarh, India |
| Address |
Department of Anaesthesia
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Saini |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesia PGIMER SECTOR 12, Chandigarh, India |
| Address |
Department of Anaesthesia
PGIMER
sECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drvsaini@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikas Saini |
Main OT complex , 4th Floor, Nehru Hospital, PGIMER |
Main OT complex and department of Anesthesia, 4 th floor, Nehru hospital, PGIMER, Sector 12
Chandigarh
CHANDIGARH |
9914207236
drvsaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, PGIMER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
posted for laparoscopic cholecystectomy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low pressure group (L) |
Inclusion and exclusion criteria will be as described above. Laparoscopic cholecystectomy will be performed after insufflation of the abdomen with pressures 8-10 mm of Hg. Induction will be performed using sleep dose of propofol, morphine (0.1mg/kg) and vecuronium(0.1mg/kg) and after intubation of the trachea anesthesia will be maintained using O2/N2O/Isoflurane. Ultrasound (HFL38/13-6MHz, Sonosite Inc,Bothell, Washington, USA)will be used for measurement of ONSD. For each subject 3 measurements will be taken on each eye.Measurements will be taken at following intervals:
T0: Before anesthesia
T1: 5 minute after induction in the supine position
T2: 10 minutes after CO2 pneumoperitoneum
T3: 10 minutes after CO2 pneumoperitoneum with 30 degree reverse Trendelenburg positioning
Subsequent readings will be taken at 20 minutes intervals
Final reading will be taken after desufflation and supine patient positioning . |
| Comparator Agent |
Standard pressure group (S) |
Inclusion and exclusion criteria will be as described above. Laparoscopic cholecystectomy will be performed after insufflation with pressures 12-16 mm Hg. Induction and maintanence of anesthesia will be as described in previous group. Measurements of ONSD will be performed as described in previous group |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients in Group S will undergo laparoscopic cholecystectomy using standard (12-16 mm Hg) pressures whereas patients in Group L will undergo laparoscopy under low pressures (8-10 mm Hg). Patients aged 18-80 years and belonging to ASA I-III will be included. |
|
| ExclusionCriteria |
| Details |
We will exclude patients with orbital trauma as optic sonography in such patients is technically difficult |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of low pressure vs standard pressure pneumoperitoneum on ICP using ocular USG to measure ONSD. |
20 minutes after CO2 pneumoperitoneum with 30 degree reverse Trendelburg position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
09/12/2014 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
CO2 pneumoperitoneum increases intracranial pressures during laparoscopy. Measurement of optic nerve sheath diameter using optic nerve ultrasound is an accurate and non invasive bedside tool for detection of raised intracranial pressure. Till date no study has compared the effect of low pressure and standard pressure for pneumoperitoneum on intracranial pressures. |