| 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
|
|
|
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 |
|
|
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. |