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CTRI Number  CTRI/2024/04/066215 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparision of drug dexmedetomidine with mannitol drug on eye pressure and pressure in the brain on laparoscopic headdown surgeries 
Scientific Title of Study   Comparison of Dexmedetomidine with Mannitol on Intraocular Pressure and Optic Nerve Sheath Diameter changes as a Surrogate Marker of Intracranial Pressure in Laparoscopic Trendelenburg Surgeries : A Randomised Double Blind Controlled Study 
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 Ashwin Kumar 
Designation  Post Graduate 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Room no: 109, First Floor, Urology OT Complex, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9841534234  
Fax    
Email  ashwink045@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasath C 
Designation  Professor 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Room no: 109, First Floor, Urology OT Complex, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9787740890  
Fax    
Email  drpathin2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwin Kumar 
Designation  Post Graduate 
Affiliation  Sri Manakula Vinayagar Medical College and Hospital 
Address  Room no: 109, First Floor, Urology OT Complex, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  9841534234  
Fax    
Email  ashwink045@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical College and Hospital 
 
Primary Sponsor  
Name  Sri Manakula Vinayagar Medical College and Hospital 
Address  Room no: 109, First Floor, Urology OT Complex, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Sri Manakula Vinayagar Medical College and Hospital  Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherr 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwin Kumar R P  Sri Manakula Vinayagar Medical College and Hospital  Room no: 109, First Floor, Urology OT Complex, Department of Anaesthesiology Sri Manakula Vinayagar Medical College and Hospital, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY 
9841534234

ashwink045@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH - ETHICS COMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj Dexmedetomidine   Measurement of Intraocular pressure and optic nerve sheath diameter before induction in supine position and Inj Dexmedetomidine 0.5µg/kg loading dose followed by administration of 0.4 µg/kg/hr measurements will be taken, 10mins after insuffalation of Pneumoperitoneum, 10mins after making the patient in Trendelenburg position, 30mins after making the patient in Trendelenburg position, 1hr after making the patient in Trendelenburg position, In Supine Position Before Extubation 
Comparator Agent  Inj Mannitol 0.5g/kg  Measurement of Intraocular pressure and optic nerve sheath diameter before induction in supine position and Inj Mannitol will be given, measurements will be taken, 10mins after insuffalation of Pneumoperitoneum, 10mins after making the patient in Trendelenburg position, 30mins after making the patient in Trendelenburg position, 1hr after making the patient in Trendelenburg position, In Supine Position Before Extubation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age 18 to 75 years old
American Society of Anaesthesiologists (ASA) physical status I to II
Laparoscopic Surgeries in Trendelenburg Position
Duration of the Surgery more than 1 hour
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Effect of Dexmedetomidine and Mannitol on Intraocular Pressure and Optic Nerve Sheath Diameter in Patients undergoing Laparoscopic Trendelenburg Surgeries  In Supine Position before induction of Anaesthesia (T0)
10mins after insuffalation of Pneumoperitoneum (T1)
10mins after making the patient in Trendelenburg position (T2)
30mins after making the patient in Trendelenburg position (T3)
1hr after making the patient in Trendelenburg position (T4)
In Supine Position
Before Extubation
(T5)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To Compare the Hemodynamic Changes in both the groups
2. To Compare the Side effect in both the group the groups
 
In Supine Position before induction of Anaesthesia (T0)
10mins after insuffalation of Pneumoperitoneum (T1)
10mins after making the patient in Trendelenburg position (T2)
30mins after making the patient in Trendelenburg position (T3)
1hr after making the patient in Trendelenburg position (T4)
In Supine Position
Before Extubation
(T5)
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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/ Phase 3 
Date of First Enrollment (India)   30/04/2024 
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  

On the day of surgery patients will be shifted into the operation theatre large bore I.V line access will be secured and Standard ASA monitors will be attached with non-invasive blood pressure (NIBP), electrocardiogram (ECG), heart rate, pulse oximetry. Hemodynamic parameters will be recorded. Baseline values of Optic nerve sheath diameter will be recorded by ultrasonography (by an experienced radiologist) and intraocular pressure will be recorded in supine position using Perkins applanation tonometer (by an experienced ophthalmologist) before general anaesthesia.  Anaesthesia protocol was standardized for drugs used in this procedure, after baseline measurement and adequate preoxygenation with 100% O2 for 3 min, Inj Glycopyrrolate 0.005mg/kg I.V and Inj midazolam 2mg I.V and Inj Fentanyl (2-3mcg/kg) I.V will be administered. Induction with Inj Etomidate 0.2mg-0.3mg/kg I.V , after loss of consciousness patient will be started with Inj Dexmedetomidine 0.5µg/kg loading dose followed by administration of 0.4 µg/kg/hr (in dexmedetomidine group)/ Inj Mannitol 0.5g/kg(in mannitol group) (these two drugs are prepared and kept concealed). Following patient will be given muscle relaxation using Inj atracurium (0.4-0.5mg/kg) I.V and after adequate ventilation for 3 mins Endotracheal  intubation will be performed by an anaesthesiologist and patient will be ventilated in volume control mode with Isoflurane as inhalational agent. During laparoscopic surgery intraperitoneal insufflation of CO2 will be  maintained  around 15mm Hg, IOP & ONSD will be measured 5mins after insufflation CO2 then patient position will be changed into trendelenburg position(>20 degrees from horizontal- measured with IV stand ), IOP and ONSD will be measured 10mins after the patient position changed in TP and measurement of IOP & ONSD will be measured at a time interval of 30mins & 60mins after making the patient in Trendelenburg position, CO2 insufflation will be stopped and evacuated by manual compressions of abdomen by open trocars, patient position will be returned to supine position, IOP and ONSD will be measured before extubation, after discontinuing volatile anaesthetics and patients will be given reversal dose of  Inj Neostigmine 0.05mg-0.08mg/kg, after adequate suction and subsequent attempts of respiration patient will be extubated and patients will be taken up to post-operative ward.

 
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