TIVA vs Inhalational Mode of Anaesthesia

Study Overview
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Brief Summary
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Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small duration cases. But in recent times, concept of rapid discharge, day care procedures, and green environment has created the need of new modalities of anaesthesia for such cases. Considering such factor, investigators have planned using TIVA i.e. total intravenous anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is feasible, cost effective and comparable to inhalational anaesthesia in terms of intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile. This comparison and analysis will help to determine if TIVA can be used as the sole mode of anaesthesia during MRM as it will initiate early discharge of patient and will contribute to the Green OT concept.

Detailed Description
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Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified Radical Mastectomy 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.

Official Title
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Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy

Conditions
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Anesthesia Awareness

Intervention / Treatment
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* Drug: Injection dexmedetomidine
* Drug: Injection, Propofol, 10 Mg
* Other: sevoflurane
* Other: nitrous oxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group: 30-65 yrs ASA status: 1-3 Use of endotracheal tube for securing the airway Exclusion Criteria: CKD, CLD patients Cardiac dysfunction Psychotic and neurotic disorders Drug addiction BMI > 30 Use of supraglottic device Use of any nerve blocks

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TIVA - total intravenous anaesthesia<br>only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia | Drug: Injection dexmedetomidine<br>* alpha 2 a agonist used for sedation, analgesia<br>* Other names: dexmed;Drug: Injection, Propofol, 10 Mg<br>* non barbiturate type of intravenous anaesthetic drug<br>* Other names: propofol spiva;|
| Other: Inhalational anaesthesia<br>In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia | Other: sevoflurane<br>* inhalational anaesthetic agent<br>Other: nitrous oxide<br>* inhalational anaesthetic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total intravenous anesthesia | Intraoperative Bispectral index maintenance between 40-60 | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost - effectiveness | cost of drugs consumed per patient in both groups | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total intravenous anesthesia