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CTRI Number  CTRI/2024/10/075369 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of effects of two drugs on intracranial pressure in adults undergoing elective laparoscopic and robotic surgery  
Scientific Title of Study   Effects of intravenous Magnesium sulphate and lignocaine on intracranial pressure in adults undergoing elective laparoscopic and robotic surgery in trendelenberg position - A randomised control trial  
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 Kunal Thakur 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anesthesiology and Critical Care office, second floor, institute block, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9042153284  
Fax    
Email  beingkthakur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mekala Ranjith Kumar 
Designation  Assistant professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anesthesiology and Critical Care office, second floor, Institute block, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9487120564  
Fax    
Email  ranjithkumar.kmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Senthilnathan M 
Designation  Associate Professor 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of anesthesiology and critical care, JIPMER

Yanam
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER campus road, Gorimedu, Dhanvantari nagar, Pondicherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kunal Thakur  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Anesthesiology and Critical Care office, second floor, Institute block, Gorimedu, Pondicherry 605006
Pondicherry
PONDICHERRY 
9042153284

beingkthakur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% Normal saline  Continuous infusion of 0.9% Normal saline till end of surgery 
Intervention  Inj magnesium sulphate and Inj Lignocaine   Continuous infusion of Inj Magnesium sulphate 10mg/kg/hr or Inj Lignocaine 1.5mg/kg/hr till the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2, between 18-65 years scheduled to undergo laparoscopic and Robotic surgery in trendelenburg position.  
 
ExclusionCriteria 
Details  H/O neurological illness / surgery
Glaucoma or ophthalmic disease other than myopia and hypermetropia
Acute or chronic ocular infection
Allergy to study drugs
Antihypertensives on calcium channel blockers
Serum creatinine more than 2.0 mg/dl
Surgical procedure duration requiring more than 6 hour
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare Optic Nerve Sheath Diameter among the groups receiving magnesium sulphate, lignocaine and 0.9% normal saline in patient undergoing elective laparoscopic and robotic surgery  Tb: after induction
T1:after giving Trendelenberg position
T2: after 1 hour of trendelenburg position
T3: every one hourly
Te: at the end of surgery during the closure of ports.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the neuromuscular recovery among the groups
To compare the time to first analgesia after surgery among the groups
To compare the intraoperative fentanyl requirement among the groups
 
Neuromuscular recovery time(Tnr) :measured at the baseline ( point where the train-of-four ratio (TOFr) reaches 0.9 after the administration of reversal agent)
Time to first analgesia after surgery(Tfas) :measured at the baseline ( point of administration of initial dose of analgesic medication to the patient after transfer from the Post-Anesthesia Care Unit (PACU).)
 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   27/10/2024 
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="2"
Months="2"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

After obtaining approval from the Postgraduate research monitoring committee (PGMRC) and Institute Ethics committee (IEC), the study will be registered in Clinical trials registry-India (CTRI). Patients who match the eligibility criteria after informed consent will be enrolled and randomised into three groups (Group A, Group B and Group C). Routine preoperative assessment will be performed by the attending anesthesiologist a day prior to the surgery. The operating surgeon will be informed regarding study a day Prior to the surgery. Informed written consent will be taken during pre-anesthetic checkup visit on the day prior to proposed surgery. Preoperative fasting instructions and Premedication’s like Tab.Famotidine 20mg and Tab.Diazepam 5mg will be given on the day before surgery and on the day of surgery. After shifting the patient to Operation theatre, ASA standard monitoring devices like pulse oximetry, ECG, and non-invasive Blood pressure, Entropy sensors will be connected and baseline parameters will be obtained. NIBP will be measured every 10min. All patients will be administered 0.02 mg/kg i.v. Midazolam before induction, after adequate pre-oxygenation, patients will be induced with  Inj.Fentanyl 2 ug.kg1 followed by Propofol 2-3 mg.kg1 titrated to the loss of response to verbal commands and will be paralyzed with Inj. Vecuronium 0.08 mg.kg1. Depth of neuromuscular blockade will be monitored at the wrist with neuromuscular monitor [Train of Four (TOF)].  After placement of endotracheal tube (ETT),  the appropriate placement of ETT will be confirmed with auscultation and capnographic tracing. Intraoperative anaesthesia will be maintained with air: oxygen mixture and depth of anaesthesia will be achieved with inhalational agent isoflurane at a minimum alveolar concentration (MAC) of 0.7-1 titrated to achieve entropy value of 40 to 60. Ventilation will be adjusted to deliver a tidal volume of 8 ml/kg of ideal body weight (IBW) and the plateau pressure will be maintained <30 cmH2O. The respiratory rate will be adjusted to maintain the end-tidal CO2 (EtCO2) between 35 and 40 mmHg. After the induction of anaesthesia, patients allocated to Group  A, lignocaine will be given as a continuous infusion @1.5 mg/kg/hr and in other group B, MgSO4 will be given as a continuous infusion with 10 mg/kg/hr and in Group C,  0.9% NS @5ml/hr continuous infusion will be given till the end of the surgery. Pneumoperitoneum will be created with intraperitoneal insufflation of CO2 with the patient in supine position. Then the patient will be positioned in the trendelenburg position slowly and surgery will be performed in the position where the target structures are visualised optimally by the operating surgeon. The degree of trendelenburg position will be measured with the help of a goniometer. Analgesia will be maintained with intermittent bolus of fentanyl 0.5ug/kg  to maintain response entropy (RE) between 40-60 and vecuronium will be administered at the dose of 1 mg when TOF count reaches 2.

The optic nerve sheath diameter (ONSD) will be assessed using a linear probe (6-13 MHz) with a small amount of gel applied gently to the upper eyelids to prevent undue pressure.  The ONSD will be measured 3 mm behind the eye globe. The ONSD will appear as a vertical hypoechoic band surrounded by retrobulbar echogenic fat tissue on the monitor, aligned perpendicularly to the ultrasonic probe.

           ONSD measurement will be performed at time points Tb: after  induction, T1:after giving Trendelenberg position, T2: after 1 hour of trendelenburg position; T3: every one hourly, Te: at the end of surgery during the closure of ports.

We will not be giving intervention after  the onset of rise in ICP as the increase in ONSD is expected to raise from the baseline which is not clinically significant. In this study, we are including patients who do not have any risk factor for developing adverse outcomes

Due to trivial increase in ICP (Ex: Patients with intracranial space occupying lesions, any previous craniotomy surgeries, patents with hydrocephalus will be excluded from this study).

Neuromuscular recovery time is  defined as the duration from the administration of reversal agents to the point where the train-of-four ratio (TOFr) reaches 0.9.

Time to first analgesia refers to the duration between a patient’s transfer from the Post-Anesthesia Care Unit (PACU) and the administration of the initial dose of analgesic medication.


 
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