| 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
|
|
|
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
|
|
|
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. |