Skip to main content
OpenTrials
Completed

NCT Number: NCT03807297

TIVA vs Inhalational Mode of Anaesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Awareness Intraoperative Awareness Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection dexmedetomidine

Drug

alpha 2 a agonist used for sedation, analgesia

Other names: dexmed

Injection, Propofol, 10 Mg

Drug

non barbiturate type of intravenous anaesthetic drug

Other names: propofol spiva

sevoflurane

Other

inhalational anaesthetic agent

Nitrous Oxide

Other

inhalational anaesthetic agent

Primary outcomes

  1. total intravenous anesthesia

    Time frame: 3 hours

    Intraoperative Bispectral index maintenance between 40-60

Secondary outcomes

  1. Cost - effectiveness

    Time frame: 3 hours

    cost of drugs consumed per patient in both groups

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.