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Anesthesia AwarenessPhase 2NCT03807297

TIVA vs Inhalational Mode of Anaesthesia

A Phase 2 study testing Injection dexmedetomidine, Injection, Propofol, 10 Mg and sevoflurane in people with Anesthesia Awareness, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia Awareness
What is being tested?
Injection dexmedetomidine, Injection, Propofol, 10 Mg and sevoflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndia
Study dates
10 Jan 2019to 30 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, National Capital Territory of Delhi, 110085

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
Injection dexmedetomidine, Injection, Propofol, 10 Mg, sevoflurane, nitrous oxide
Keywords
total intravenous anesthesia
Medical subject headings
Intraoperative Awareness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection dexmedetomidineDrug

    Also called dexmed

    alpha 2 a agonist used for sedation, analgesia

  • Injection, Propofol, 10 MgDrug

    Also called propofol spiva

    non barbiturate type of intravenous anaesthetic drug

  • sevofluraneOther

    inhalational anaesthetic agent

  • nitrous oxideOther

    inhalational anaesthetic agent

Study groups in NCT03807297
Study groupRoleWhat they receive
TIVA - total intravenous anaesthesiaOtheronly intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
Receives: Drug: Injection dexmedetomidine; Drug: Injection, Propofol, 10 Mg
Inhalational anaesthesiaOtherIn this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
Receives: Other: sevoflurane; Other: nitrous oxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total intravenous anesthesia

    Intraoperative Bispectral index maintenance between 40-60

    Measured: 3 hours

Secondary outcomes (1)

  1. Cost - effectiveness

    cost of drugs consumed per patient in both groups

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start10 Jan 2019
  3. Primary completion30 Nov 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807297
Sponsor's protocol ID
RajivGCIRC2
Status last verified
Feb 2020
First submitted
5 Jan 2019
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Injection dexmedetomidine, Injection, Propofol, 10 Mg and sevoflurane in people with Anesthesia Awareness, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total intravenous anesthesia (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03807297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.

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