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A clinical trial to study the effects of two drugs, 20% mannitol and Dexmedetomidine in decreasing intracranial pressure in patient undergoing laproscopic surgery.

Comparison of the effect of 20% Mannitol and Dexmedetomidine for prevention of the raised intracranial pressure by evaluating Optic nerve sheath diameter(ONSD) during Laproscopic surgery in Trendelenburg position.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049044
Enrollment
56
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N879- Dysplasia of cervix uteri, unspecified

Interventions

Intervention1: 20% MANNITOL: MANNITOL WILL BE GIVEN AT A DOSE OF 0.5 mg/kg BODY WEIGHT, 5 mins AFTER CRAETING PNEUMOPERITONEUM TO THE PATIENT AND IT WILL BE GIVEN OVER 30 MINUTES. Control Interventio

Sponsors

Dr. Vivek Vishal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged >18 years & - patients willing to participate - BMI between 20 to 30 kg/m2 - ASA GRADE - I to III - patients with normal ocular anatomy and physiology. - MPG class 1 to 3 - Patient posted for Laproscopic surgery

Exclusion criteria

Exclusion criteria: - Patient refusal to participate. - MPG class 4 - Patient aged 70 years undergoing Laproscopic surgeries - ASA GRADE > III - BMI 30 kg/m2 - History of Hypertension - Past history of any Neurological disease. - Viral markers positive (HIV, HBsAg, antiHCV)

Design outcomes

Primary

MeasureTime frame
Effect of the drugs 20% Mannitol and Dexmedetomidine in Decreasing intracranial pressure during Laproscopic surgery by Ultrasonographic measurement of Optic Nerve Sheath Diameter(ONSD) in Trendelenburg positionTimepoint: Before induction of anaesthesia,5 ins after induction, 5 mins after creating pneumoperitoneum,10 mins after giving brespective drugs, every 30 mins of intraop duration.

Secondary

MeasureTime frame
1- To evaluate the hemodynamic effects of change in ICP during Laproscopic surgery in Trendelenburg position. 2- To study about nausea, vomiting or any other side effects . Timepoint: Before induction,5 mins after induction, 5mins after creating pneumoperitoneum, 10 mins after giving mannitol or dexmedetomedidine, every 30 mins after giving drug.

Countries

India

Contacts

Public ContactVIVEK VISHAL

INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA

vivekvishal999@gmail.com8252618307

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026