TIVA vs Inhalational Mode of Anaesthesia
Condition: Anesthesia Awareness
MeSH terms: Intraoperative Awareness
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): Injection dexmedetomidine; Injection, Propofol, 10 Mg; sevoflurane; nitrous oxide
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): alpha 2 a agonist used for sedation, analgesia; non barbiturate type of intravenous anaesthetic drug; inhalational anaesthetic agent; inhalational anaesthetic agent
Other intervention name(s): dexmed; propofol spiva
Intervention MeSH terms: Dexmedetomidine; Nitrous Oxide; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: total intravenous anesthesia