TIVA vs Inhalational Mode of Anaesthesia
- Conditions
- Anesthesia Awareness
- Interventions
- Other: sevofluraneDrug: Injection, Propofol, 10 MgOther: nitrous oxide
- Registration Number
- NCT03807297
- Lead Sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Age group: 30-65 yrs
- ASA status: 1-3
- Use of endotracheal tube for securing the airway
- CKD, CLD patients
- Cardiac dysfunction
- Psychotic and neurotic disorders
- Drug addiction
- BMI > 30
- Use of supraglottic device
- Use of any nerve blocks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhalational anaesthesia sevoflurane In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia TIVA - total intravenous anaesthesia Injection dexmedetomidine only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia TIVA - total intravenous anaesthesia Injection, Propofol, 10 Mg only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia Inhalational anaesthesia nitrous oxide In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
- Primary Outcome Measures
Name Time Method total intravenous anesthesia 3 hours Intraoperative Bispectral index maintenance between 40-60
- Secondary Outcome Measures
Name Time Method Cost - effectiveness 3 hours cost of drugs consumed per patient in both groups
Trial Locations
- Locations (1)
Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳New Delhi, Delhi, India