Study to compare the extent to which brain matter is normal with a well known score in patients with cancer at posterior part of brain between two groups:those that receive Mannitol ( drug that has been shown to decrease brain swelling in other studies) with those that receive normal saline

To compare Brain Relaxation Score in Cerebello-Pontine Angle tumor surgeries using Mannitol with Placebo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018973

Enrollment

Registered

2019-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: D496- Neoplasm of unspecified behavior of brain

Interventions

Intervention1: Mannitol infusion: 20% mannitol infusion at the dose of 1g/kg given intravenously once at the time of incision over 20 minutes Control Intervention1: Normal Saline: Equal volume of norm

Eligibility

Inclusion criteria

Inclusion criteria: Any patient undergoing Cerebello-pontine Angle tumor resection in supine position, Age between 18 to 65 years, ASA I and II patients

Exclusion criteria

Exclusion criteria: Patient refusal for consent, Surgery performed in sitting position, Patients on preoperative osmotic therapy, Patients with severe systemic illness such as renal failure, hepatic failure, congestive heart failure, coronary artery disease or severe valvular disease

Design outcomes

Primary

Measure	Time frame
To compare Brain Relaxation Score between two groups by surgeonsTimepoint: Just before dura is opened and just after dura is opened	—

Secondary

Measure	Time frame
To compare Brain Relaxation Score between two groups by anesthetistsTimepoint: Before and after dural opening;To note any perioperative complications in both the groupsTimepoint: During surgery and within 24 hours post surgery;To note total duration of hospital stay in both the groupsTimepoint: Total duration of hospital stay;To study and compare the hemodynamic parameters between two groupsTimepoint: Every 2 hours;To study and compare the serum electrolytes and serum osmolarity between two groupsTimepoint: Baseline, 1 hour post intervention and closure	—

Measure

Time frame

To compare Brain Relaxation Score between two groups by anesthetistsTimepoint: Before and after dural opening;To note any perioperative complications in both the groupsTimepoint: During surgery and within 24 hours post surgery;To note total duration of hospital stay in both the groupsTimepoint: Total duration of hospital stay;To study and compare the hemodynamic parameters between two groupsTimepoint: Every 2 hours;To study and compare the serum electrolytes and serum osmolarity between two groupsTimepoint: Baseline, 1 hour post intervention and closure

—

Countries

India

Contacts

Public ContactSabina Regmi

Post Graduate Institute of Medical Education and Research

sappu.r@gmail.com978697467

Outcome results

None listed

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