| CTRI Number |
CTRI/2024/06/068231 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the impact of two different anaesthetic agents on diameter of the Optic Nerve Sheath during Laparoscopic Surgeries. |
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Scientific Title of Study
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An Open Labelled Randomized Controlled Trial to compare the effect of Desflurane and Target Controlled Infusion of Propofol on Optic Nerve Sheath Diameter in patients undergoing Laparoscopic Procedures |
| 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 Naveena H |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth University |
| Address |
3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra
Pune MAHARASHTRA 411043 India |
| Phone |
8589068156 |
| Fax |
|
| Email |
naveena.h143@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kalyani Nilesh Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth University |
| Address |
3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra
Pune MAHARASHTRA 411043 India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kalyani Nilesh Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth University |
| Address |
3rd Floor, MOT Complex, Department of Anesthesiology, Bharati Hospital, Dhankawadi, Pune- 43, Maharashtra
Pune MAHARASHTRA 411043 India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anesthesiology,
Bharati Vidyapeeth (Deemed to be) University Medical College, Pune, Maharashtra- 411043, India |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth (Deemed to be) University Medical College, Pune |
| Address |
Bharati Vidyapeeth Campus, Pune - Satara Road,Dhankawadi, Pune 411043 |
| Type of Sponsor |
Private medical college |
|
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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 Kalyani Nilesh Patil |
Bharati Hospital |
Department of Anaesthesia, 3rd floor major operation Complex Pune MAHARASHTRA |
9673400066
kalyanish19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be) University Medical College, Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of Desflurane on optic nerve sheath diameter in patients undergoing laparoscopic surgeries. |
After tracheal intubation, anaesthesia will be maintained with Desflurane within the rage of 4%-7%. ONSD will be measured after induction, 10 minutes after insufflation, first hour, second hour, third hour after insufflation and final reading will be taken after desufflation. |
| Comparator Agent |
Effect of target controlled Propofol on optic nerve sheath diameter in patients undergoing laparoscopic surgeries. |
After tracheal intubation, anaesthesia will be maintained with Propofol through Target Controlled Infusion (TCI) System. The effect site concentration of Propofol will be maintained at 3- 4 microgram/ml. ONSD will be measured after induction, 10 minutes after insufflation, first hour, second hour, third hour after insufflation and final reading will be taken after desufflation. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA I, II, in the group of 18-60 years, posted foe elective laparoscopic surgeries under general Anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusing for the study
Patients with existing neurological diseases
eye disease like glaucoma, lens opacity or trauma.
Pre- existing raised ICP
History of Craniotomy
Pregnancy, breast feeding patients |
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Desflurane and Target Controlled Infusion of Propofol on Optic Nerve Sheath Diameter in patients undergoing Laparoscopic surgeries. |
ONSD will be measured in both the groups of patients after induction, 10 min,1 hour, 2 hour, 3 hour after Co2 insufflation and final reading will be taken after desufflation. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the change in Optic Nerve Sheath Diameter with End Tidal Carbon dioxide concentration (EtCo2) |
EtCo2 will be measured along with ONSD after induction, 10 min, 1 Hour, 2 Hour, 3 Hour after CO2 insufflation and final reading will be taken after desufflation. |
|
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Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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 2 |
|
Date of First Enrollment (India)
|
13/06/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Laparoscopic surgery is rapidly growing alternative technique to conventional open surgery for many types of surgical procedures because of it’s minimum blood loss, minimal invasiveness, less post operative pain and a consequent earlier discharge. Despite many advantages of laparoscopic procedures the disadvantages of elevated intracranial pressure (ICP) and intra ocular pressure (IOP) remains which caused by steep angle of Trendelenberg position and the induced Co2 pneumoperitoneum. Laparoscopy involves Co2 insufflation to create pneumoperitoneum for enhancement of operative visual field and often steep head-down position (up to 45 degree Trendelenberg position). This Co2 gets absorbed in systemic circulation and arterial levels of Co2 increased. Co2 insufflation during pneumoperitoneum creation is associated with physiological changes resulting in a typical state of increased IOP during laparoscopic surgery. There are various methods for detection of intracranial pressure both invasive and non invasive. • Invasive methods are costly require special precautions and strict neurological settings associated with serious complications like brain damage, hemorrhage, infection. • There are non invasive methods like cranial CT, MRI, USG. Amongst non invasive methods USG guided ONSD is the best. Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) is simple, non invasive, and accurate ICP assessment technique. Ultrasound of 6-15 Hz high frequency probe is used for ONSD measurement. AIM To compare the effect of Desflurane and target controlled infusion of Propofol on optic nerve sheath diameter in patients undergoing laproscopic surgeries OBJECTIVES : Primary Objective: To compare the effect of Desflurane and target controlled infusion of Propofol on optic nerve sheath diameter in patients undergoing laproscopic surgeries. Secondary Objective: To correlate the change in optic nerve sheath diameter with end tidal carbondioxide concentration (EtCo2)
METHODOLOGY The patients will be informed about the study in a language they fully comprehend. The patient will be enrolled in the study after taking a written informed consent. A computer - generated table of random numbers will be used randomly to divide the patients into two groups : Patients that will receive inhalational anesthesia with Desflurane (Group I) and patients that will receive propofol- based TIVA (Group II) . After identification, On arrival into the operating room patient’s baseline parameters will be recorded. I.V Line to be secured. Glycopyrrolate (0.2mg) and midazolam (0.05mg/kg) will be administered before induction of anaesthesia in both groups. In Group I patients, Patients will be oxygenated with 100% Oxygen for 3 minutes. General anaesthesia is induced with 1.5mg/kg propofol , 2mcg/kg fentanyl and muscle relaxation will be achieved with IV atracurium 0.5mg/kg. Following tracheal intubation, anaesthesia will be maintained with Desflurane. The end –tidal concentration of desflurane will be maintained within the range of 4%-7%. In Group II patients, after tracheal intubation, anesthesia will be maintained with Propofol through Target Controlled Infusion (TCI) system. Patient’s ONSD will be measured in both eyes using 7.5 MHz Linear Ultrasound probe. ONSD will be measured after induction (T0), 10 min after insufflation (Ti), 1st Hour, 2nd Hour, 3rd Hour, 4th Hour (T1, T2, T3, T4 respectively). Final reading will be taken after desufflation. Respiratory parameters (Peak airway pressure, End- tidal CO2) along with ONSD.
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