TIVA vs Inhalational Mode of Anaesthesia

NCT03807297 | Completed Phase 2 DMC

• 1 other identifier: RajivGCIRC2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Awareness

Keywords

total intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• total intravenous anesthesia

  Intraoperative Bispectral index maintenance between 40-60

  3 hours

Secondary Outcomes (1)

• Cost - effectiveness

  3 hours

Study Arms (2)

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

Drug: Injection dexmedetomidine; Drug: Injection, Propofol, 10 Mg

Inhalational anaesthesia

OTHER

In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia

Other: sevoflurane; Other: nitrous oxide

Interventions

Injection dexmedetomidine DRUG

alpha 2 a agonist used for sedation, analgesia

Also known as: dexmed

TIVA - total intravenous anaesthesia

Injection, Propofol, 10 Mg DRUG

non barbiturate type of intravenous anaesthetic drug

Also known as: propofol spiva

TIVA - total intravenous anaesthesia

sevoflurane OTHER

inhalational anaesthetic agent

Inhalational anaesthesia

nitrous oxide OTHER

inhalational anaesthetic agent

Inhalational anaesthesia

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group: 30-65 yrs
• ASA status: 1-3
• Use of endotracheal tube for securing the airway

You may not qualify if:

• CKD, CLD patients
• Cardiac dysfunction
• Psychotic and neurotic disorders
• Drug addiction
• BMI \> 30
• Use of supraglottic device
• Use of any nerve blocks

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (1)

Rajiv Gandhi Cancer Institute and Research Centre

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

Location

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Injections; Propofol; Sevoflurane; Nitrous Oxide

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• NITESH GOEL, MBBS,DA,DNB

  Rajiv Gandhi Cancer Institute And Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nitesh Goel - Consultant Anaesthesia

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

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 16, 2019
• Study Start: January 10, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

IN (1)