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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/01/006574 |
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Date of registration:
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28-01-2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of avoidance of nitrous oxide during anaesthesia in patients undergoing brain tumour surgery.
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Scientific title:
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The effect of sevoflurane-air versus sevoflurane-nitrous oxide anaesthesia on length of ICU and hospital stay in patients undergoing cerebellopontine tumour surgery- a randomised controlled trial. |
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Date of first enrolment:
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01-03-2016 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13123 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Mihir Prakash Pandia
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Address:
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Room No. 709
Dept. of Neuroanaesthesia
Neurosciences Centre
AIIMS, New Delhi
110029
South West, DELHI
India |
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Telephone:
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Email:
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pandiamihir@gmail.com |
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Affiliation:
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AIIMS |
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Name:
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Mihir Prakash Pandia
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Address:
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Room No. 709
Dept. of Neuroanaesthesia
Neurosciences Centre
AIIMS, New Delhi
110029
South West, DELHI
India |
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Telephone:
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Email:
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pandiamihir@gmail.com |
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Affiliation:
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AIIMS |
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Key inclusion & exclusion criteria
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Inclusion criteria: ASA grade I & II patients.
Patients of cerebellopontine angle tumours posted for elective tumour excision surgery.
Anticipated duration of anaesthesia more than 6 hours.
Exclusion criteria: Refusal of consent.
Patients with history of smoking.
Haemodynamically unstable patients.
Hb < 8gm%.
Evidence of pneumocephalus on CT scan.
Patients with evidence of pneumothorax.
Patients with bleeding disorders.
Patients with preoperative GCS <15.
Patients with significant pulmonary disease, renal or hepatic disorders, unstable angina, uncontrolled diabetes or hypertension.
Pregnant females.
Patients operated upon in sitting position.
Patients with BMI > 35.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Cerebellopontine angle tumours
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Intervention(s)
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Intervention1: Nitrous Oxide: Nitrous Oxide with Oxygen (FiO2 0.4) with Sevoflurane
Control Intervention1: Nitrous oxide: Nitrous oxide with Oxygen (FiO2 0.4) with Sevoflurane
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Primary Outcome(s)
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To compare the mean duration of ICU stay and hospital stay.Timepoint: At time of discharge from ICU and at time of discharge from hospital
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Secondary Outcome(s)
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1. To compare intraoperative brain condition, emergence, duration of postoperative ventilation and GOS at discharge.
2. To compare the incidence of hemodynamic fluctuations and complications in the intraoperative and postoperative period.
Timepoint: 1. During surgery and post operative period
2. During surgery and post operative period
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Source(s) of Monetary Support
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All India Institute of Medical Sciences, New Delhi
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Ethics review
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Status: Approved
Approval date: 27/11/2015
Contact:
Institute Ethics Committee for Post Graduate Research, AIIMS
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/03/2017 |
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URL:
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