Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2019-01-10
2019-12-30
Brief Summary
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Detailed Description
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Objective:
* Feasibility of TIVA in Modified Radical Mastectomy
* Cost - effectiveness of TIVA Vs Inhalational anesthesia
* Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing intraoperative hemodynamic parameters and recovery profile.
Study design: It will be a prospective randomized controlled interventional type of study.
Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T) and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.
In group T: (TIVA): Inj. Dexmedetomidine will be started at induction @1mcg/kg over 10 min followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for maintenance of anaesthesia.
In group I: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and sevoflurane will be started at induction.
In both groups drugs and gases (respective to groups) will be titrated to maintain a bispectral index value between 40-60. Anaesthetic drugs will be stopped at last skin suture. Soon after reversal- recovery profile, modified Aldrete score will be recorded along with time taken to first eye opening and attainment of BIS value of \>90. At the end of case amount of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol, dexmedetomodine- for cost analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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TIVA - total intravenous anaesthesia
only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
Injection dexmedetomidine
alpha 2 a agonist used for sedation, analgesia
Injection, Propofol, 10 Mg
non barbiturate type of intravenous anaesthetic drug
Inhalational anaesthesia
In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
sevoflurane
inhalational anaesthetic agent
nitrous oxide
inhalational anaesthetic agent
Interventions
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Injection dexmedetomidine
alpha 2 a agonist used for sedation, analgesia
Injection, Propofol, 10 Mg
non barbiturate type of intravenous anaesthetic drug
sevoflurane
inhalational anaesthetic agent
nitrous oxide
inhalational anaesthetic agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA status: 1-3
* Use of endotracheal tube for securing the airway
Exclusion Criteria
* Cardiac dysfunction
* Psychotic and neurotic disorders
* Drug addiction
* BMI \> 30
* Use of supraglottic device
* Use of any nerve blocks
30 Years
65 Years
ALL
Yes
Sponsors
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Rajiv Gandhi Cancer Institute & Research Center, India
OTHER
Responsible Party
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Dr. Nitesh Goel
Dr. Nitesh Goel - Consultant Anaesthesia
Principal Investigators
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NITESH GOEL, MBBS,DA,DNB
Role: PRINCIPAL_INVESTIGATOR
Rajiv Gandhi Cancer Institute And Research Centre
Locations
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Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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RajivGCIRC2
Identifier Type: -
Identifier Source: org_study_id
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