Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified Radical Mastectomy
Objective:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA - total intravenous anaesthesia | Other | only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia |
|
| Inhalational anaesthesia | Other | In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection dexmedetomidine | Drug | alpha 2 a agonist used for sedation, analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| total intravenous anesthesia | Intraoperative Bispectral index maintenance between 40-60 | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cost - effectiveness | cost of drugs consumed per patient in both groups | 3 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| NITESH GOEL, MBBS,DA,DNB | Rajiv Gandhi Cancer Institute And Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajiv Gandhi Cancer Institute and Research Centre | New Delhi | National Capital Territory of Delhi | 110085 | India |
Not provided
| ID | Term |
|---|---|
| D058926 | Intraoperative Awareness |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D010636 | Phenols |
Not provided
Not provided
two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Not provided
Not provided
participants will be alloted in two groups as per chit system and won't be aware of type of anaesthesia, investigator won't be aware of type of anaesthesia and will record the data.
| Injection, Propofol, 10 Mg | Drug | non barbiturate type of intravenous anaesthetic drug |
|
|
| sevoflurane | Other | inhalational anaesthetic agent |
|
| nitrous oxide | Other | inhalational anaesthetic agent |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |