Clinical trial NCT03807297: TIVA vs Inhalational Mode of Anaesthesia
Official title: Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia Awareness
Keywords: total intravenous anesthesia
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: total intravenous anesthesia
timeFrame: 3 hours
Secondary outcomes:
measure: Cost - effectiveness
timeFrame: 3 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
state: Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute And Research Centre
name: NITESH GOEL, MBBS,DA,DNB
role: PRINCIPAL_INVESTIGATOR
References: