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TIVA vs Inhalational Mode of Anaesthesia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807297
Enrollment
100
Registered
2019-01-16
Start date
2019-01-10
Completion date
2019-12-30
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Awareness

Keywords

total intravenous anesthesia

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.

Interventions

DRUGInjection dexmedetomidine

alpha 2 a agonist used for sedation, analgesia

DRUGInjection, Propofol, 10 Mg

non barbiturate type of intravenous anaesthetic drug

OTHERsevoflurane

inhalational anaesthetic agent

OTHERnitrous oxide

inhalational anaesthetic agent

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
total intravenous anesthesia3 hoursIntraoperative Bispectral index maintenance between 40-60

Secondary

MeasureTime frameDescription
Cost - effectiveness3 hourscost of drugs consumed per patient in both groups

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026