A study comparing the effectiveness of 20% mannitol versus 3% saline to see if there is any difference in outcome of patients who are undergoing surgery for brain tumor.
- Conditions
- Malignant neoplasm of brain, unspecified,
- Registration Number
- CTRI/2019/09/021218
- Lead Sponsor
- All India Institute of Medical Sciences Bhubaneswar
- Brief Summary
The prospective randomized controlled trial will seek to evaluate whether there is any difference in clinical outcome among patients receiving equi-osmolar doses of 3% hypertonic saline and 20% mannitol undergoing elective supratentorial craniotomy for brain tumor. The study will comprise of total 140 patients who will be divided into two groups. 70 patients in 3%hypertonic saline group (Group N) and 70 patients in 20% mannitol group (Group M). Anaesthesia will be standardised in both the groups, either of the drug will be given at 5ml/kg body weight dose from the starting of skin incision till 1 hour. Second and subsequent doses will be given according to clinical need. Fluid management will be according to the clinicians discretion. If the hypertonic saline group developes serum sodium level more than 145meq/L and require more doses, they will be cross over to mannitol group and will be analysed at the end of the study as an intention to treat basis. Primary outcome will be the length of postoperative hospital stay between the two groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 140
•18- 60 years •Both gender •ASA I and ASA II •All supratentorial tumors both intraaxial and extra-axial measuring less than 10 cm in any dimension posted for craniotomy in elective neurosurgery OT in AIIMS Bhubaneswar.
1 Emergency cases 2 Receiving Mannitol or HTS in previous 24 hours 3 GCS <10 4 Raised serum creatinine > 1.2 mg/dl 5 Preoperative hyponatremia (Na<130) 6 Preoperative hypernatremia (Na>145) 7 Deep location of tumour.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Duration of postoperative hospital stay 1. Duration of postoperative hospital stay- at the time of discharge.
- Secondary Outcome Measures
Name Time Method Duration of ICU stay Duration of ICU stay in days at the time of discharge from Need for blood transfusion in the first 24 hours blood transfusion in first 24 hours during ICU stay Difference in c-reactive protein between 2 groups after 24 hours After 24 hours from the time of ICU stay Any complications during ICU stay I Infection Difference in serum creatinine between 2 groups at 24 and 48 hours 24 hours and 48 hours after ICU admission. Duration of mechanical ventilation (in hours) Mechanical ventilation in hours during ICU stay 3 months mortality and Glasgow outcome scale extended (after hospital discharge) After hospital discharge, 3 months after hospital discharge Intraoperative and 24 hours fluid requirement (in liters) Intraoperative and first 24 hours in ICU
Trial Locations
- Locations (1)
All India Institute Of Medical Sciences Bhubaneswar
🇮🇳Khordha, ORISSA, India
All India Institute Of Medical Sciences Bhubaneswar🇮🇳Khordha, ORISSA, IndiaDr Dona SahaPrincipal investigator9051575159donasaha.cnmc@gmail.com