TIVA vs Inhalational Mode of Anaesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Awareness
• Intervention / Treatment: Drug: Injection dexmedetomidine; Drug: Injection, Propofol, 10 Mg; Other: sevoflurane; Other: nitrous oxide

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: TIVA - total intravenous anaesthesia; only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia	Drug: Injection dexmedetomidine; alpha 2 a agonist used for sedation, analgesia; Other Names: dexmed; Drug: Injection, Propofol, 10 Mg; non barbiturate type of intravenous anaesthetic drug; Other Names: propofol spiva
OTHER: Inhalational anaesthesia; In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia	Other: sevoflurane; inhalational anaesthetic agent; Other: nitrous oxide; inhalational anaesthetic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total intravenous anesthesia	Intraoperative Bispectral index maintenance between 40-60	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost - effectiveness	cost of drugs consumed per patient in both groups	3 hours

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: NITESH GOEL, MBBS,DA,DNB, Rajiv Gandhi Cancer Institute and Research Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: January 5, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (ACTUAL): January 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: total intravenous anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Dexmedetomidine; Sevoflurane; Nitrous Oxide
• Other Study ID Numbers: RajivGCIRC2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No