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CTRI Number  CTRI/2026/02/104597 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy 
Scientific Title of Study   Effect of intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy : A double blind randomised 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 MARWAHA 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  5th floor ssrb building Institute of Anaesthesiology Pain and Perioperative Medicine SGRH

South
DELHI
110060
India 
Phone  9811076205  
Fax    
Email  drashwinmarwaha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ASHWIN MARWAHA 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Institute of Anaesthesiology Pain and Perioperative Medicine SGRH


DELHI
110060
India 
Phone  9811076205  
Fax    
Email  drashwinmarwaha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Fiza Farhat 
Designation  DNB trainee 
Affiliation  sir Gangaram hoapital 
Address  Institute of Anaesthesiology Pain & Perioperative Medicine SGRH New Delhi 110060 India

South
DELHI
110060
India 
Phone  8707585011  
Fax    
Email  farhatfiza4@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital, New Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor SSRB Block D, SGRH, Old Rajinder Nagar, Delhi 110060 Sir Ganga Ram hospital, New Delhi-110060, INDIA 
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 ASHWIN MARWAHA  Sir Gangaram Hospital  Room No 10 Ssrb 5TH Floor SGRH New Delhi
Central
DELHI 
9811076205

drashwinmarwaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  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  IV infusion of 20% mannitol (0.5g/kg i.e. 2.5ml/kg)  to see the effect of mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy over a period of 30 mins after taking a baseline reading of onsd 
Comparator Agent  iv infusion of 20 percent saline(0.5g/kg i.e2.5ml/kg)  to see the effect of mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy over a period of 30 mins after taking a baseline reading of onsd 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Age 18-65 years.
ASA physical status I and II.
Patients scheduled for elective total laparoscopic hysterectomy. 
 
ExclusionCriteria 
Details  Non consenting Patients
2. Patients with severe Cardiac or pulmonary disease
3. Patients with pre-existing glaucoma/ocular surgery
4. Patients with pre-existing raised intracranial pressure/ cerebellar vascular disease
5. Patients with active intracranial bleed
6. History of allergy to mannitol
7. Combined with any other surgery  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
ONSD- will be measured at different time interval
 

T0 5 minutes after induction
T1 5 minutes after Trendelenburg position

T2 30 minutes after Trendelenburg position

T3 60 minutes after Trendelenburg position

T4 90 minutes after Trendelenburg position

T5 120 minutes after Trendelenburg position

T6 5 minutes after desufflation
 
 
Secondary Outcome  
Outcome  TimePoints 
Recovery from anaesthesia:
Extubation time
Time to respond to verbal command
Quality of response to a verbal command – using OASS score
 
POST CESAREAN 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   01/04/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Total laparoscopic hysterectomy is a popular and rapidly growing surgical alternative technique in gynaecological surgeries as they offer significant advantages i.e. minimal invasion, reduced bleeding, reduced postoperative pain which translate into shorter hospital stay. These approaches present unique challenges to the anaesthesiologists in terms of Trendelenburg position along with pneumoperitoneum. These procedures result in increase in intracranial pressure (ICP) due to Trendelenburg positioning and pneumoperitoneum. A raised intra cranial pressure (ICP) can result in decreased cerebral perfusion pressure (CPP), which in turn can cause cerebral ischemia and delayed recovery.

A simple, non-invasive and reproducible bedside technique for assessment of intracranial pressure (ICP) is sonographically measured optic nerve sheath diameter (ONSD). Increase in optic nerve sheath diameter (ONSD) is surrogate for increase in intracranial pressure (ICP). Mannitol, a hyperosmolar agent, is widely used in anaesthesia practice as a diuretic. Mannitol exerts its diuretic effect by decreasing the reabsorption of water and sodium across the renal tubules. Mannitol has been used to counter the increase in intracranial pressure in a variety of clinical situations. It is also being used in laparoscopic surgeries in Trendelenburg position. However no formal study has been done on this. Therefore, further research is needed to substantiate its use in this clinical situation.

 

 

We will enroll a minimum of 42 patients who will be scheduled to undergo total laparoscopic hysterectomy in Trendelenburg position. These patients will be divided in two groups (study and placebo group) and a randomized study will be conducted to study the effect of intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy. The primary objective of the study is to measure the effect of


intraoperative mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy between the two study groups. The secondary objectives is to study the cognitive dysfunction between the two study groups. All the patients undergoing total laparoscopic hysterectomy will be screened, and those found eligible will be enrolled. Enrolled patients will be divides in two groups. Group M will receive IV infusion of 20% mannitol (0.5g/kg i.e. 2.5ml/kg) given over a duration of 30 minutes and group N will receive placebo (normal saline) by the same route. The primary objective of the study is to measure the intraoperative effect of mannitol on optic nerve sheath diameter in patients undergoing total laparoscopic hysterectomy between the two study groups. We hypothesize that the use of mannitol will prevent the increase of intracranial pressure during total laparoscopic hysterectomy.

 
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