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HemodynamicsPhase 4InductionNCT02807610

Etomidate vs Propofol-Induction Characteristics

A Phase 4 study testing Inj Etomidate and Injection Propofol in people with Hemodynamics and Side Effects, run by Maharashtra University of Health Sciences.

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

The ideal induction agent for day care surgery should have properties of rapid, smooth induction, better haemodynamic profile, faster recovery and devoid of side effects in the form of pain on injection, involuntary movements, respiratory depression and post-operative nausea/vomiting. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Hemodynamics, Side Effects
What is being tested?
Inj Etomidate and Injection Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
No sites listed yet
Study dates
Mar 2011to Apr 2013
Phase
Phase 4
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 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • ASA I and II Female patients
  • Elective Medical Termination of Pregnancy (MTP) surgery

Who cannot join

  • Hemo-dynamically unstable patients
  • Allergic to egg protein
  • Patients with epilepsy

About this study

Official title: Comparison of Induction Characteristics of Two Anaesthetic Agents-Etomidate Lipuro and Propofol

The ideal induction agent for day care surgery should have properties of rapid, smooth induction, better haemodynamic profile, faster recovery and devoid of side effects in the form of pain on injection, involuntary movements, respiratory depression and post-operative nausea/vomiting. Propofol is the drug being used for day care surgeries because of its rapid, smooth induction and faster recovery. But its use is associated with pain on injection (even with added lidocaine), hypotension and respiratory depression. So the need for an agent with better hemodynamic control and lesser side effects was felt. The introduction of etomidate lipuro revolutionised the anaesthesia practice. It possesses many of the properties of an ideal induction agent. This newer formulation of etomidate in lipid emulsion i.e. etomidate lipuro is known to have rapid, smooth induction, haemodynamic stability and lesser side effects than older etomidate with propylene glycol (hypnomidate).

Hence, investigators devised a prospective randomized controlled open trial and compared this newer lipid formulation of etomidate with propofol in terms of - induction time, haemodynamic parameters and side effect profile.

Read the detailed description

The administration of a suitable drug by intravenous route for induction of anaesthesia has been an important component of anaesthetic management.The ability to deliver safe and effective anaesthesia with minimal side effects and rapid recovery is critically important to ensure safe and early discharge. An ideal intravenous (IV) anaesthetic agent should, have rapid onset, rapid recovery, be without undesirable cardiac and respiratory depression and lesser untoward effects like pain on injection, nausea, vomiting etc.No single drug is ideal.

Propofol (propofol 1%) has a smooth and rapid induction, rapid recovery, cerebro-protective effect but it causes hypotension, bradycardia, respiratory depression pain on injection.Etomidate is a hypnotic agent causing minimal histamine release and very stable hemodynamic profile. In the present study, investigators evaluated the induction characteristics and side effect profile of this newer lipid formulation of etomidate and compared it with propofol in same lipid formulation.

Material and Methods: Hundred ASA I \& II patients in the age group 18-60 yrs, scheduled for dilatation and curettage procedure were randomly allocated in two groups based on induction agent Etomidate lipuro or Propofol.

Both groups received intravenous midazolam 0.02mg /kg and fentanyl 2 µg /kg as premedication. After induction with the desired agent titrated to bispectral index Entropy 40, the time to achieve BIS values to 40 (BIS 40 time) were measured. Heart rate, mean arterial pressures were recorded at baseline, induction and upto 10 minutes. Patients were asked for pain at the injection site, postoperative nausea and observed visually for myoclonus, apnea and thrombophlebitis.

Being tested
Inj Etomidate, Injection Propofol, Placebo for Propofol
Keywords
Etomidate lipuro, Induction characteristics

What participants receive

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

  • Inj EtomidateDrug

    Also called Etomidate Lipuro

    Induction of anesthesia using IV Etomidate 0.3mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0'.2mg kg-1 and IV Fentanyl 2ug kg-1.

  • Injection PropofolDrug

    Induction of anesthesia using IV Propofol 2mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0.2mg kg-1 and IV Fentanyl 2ug kg-1

  • Placebo for PropofolDrug

    After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given.

Study groups in NCT02807610
Study groupRoleWhat they receive
IV Propofol and IV Etomidate lipuroExperimentalAfter premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group P Patients received IV Propofol 2mg kg-1 slowly over 60 seconds till Entropy of 40 as a comparator agent in patients undergoing Medical termination of pregnancy(MTP) and Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP
Receives: Drug: Inj Etomidate; Drug: Injection Propofol
IV Etomidate Lipuro and PlaceboActive comparatorAfter premedication with IV midazolam 0.2mg kg-1, IV Fentanyl 2ug kg-1, Group ' E' Patients received IV Etomidate Lipuro 0.3mg kg-1 slowly over 60 seconds till Entropy of 40 as intervention agent in patients undergoing MTP and placebo group received normal saline
Receives: Drug: Inj Etomidate; Drug: Placebo for Propofol

What is being measured

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

  1. Heart rate per minute

    Mean of Heart rate per minute at above mentioned time intervals was measured and any study drug causing bradycardia (Heart rate <50 was noted .

    Measured: Change in Heart rate per minute from baseline value every five minutes for 30 minutes.

  2. Mean Arterial Pressure

    Mean value of Mean Arterial Pressures(Summation of MAP divided by number of patients) at above mentioned time intervals was noted and study drug causing Hypotension(MAP< 90mm of Hg) was noted.

    Measured: Change in Mean Arterial Pressure(MAP) in mm of Hg from baseline value every 5 minutes for 30 minutes

Secondary outcomes (3)

  1. Side effects of the drugs in the form of Pain on injection

    1. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. 0. No pain. I. Verbal complaint of pain. II. Withdrawal of arm. III. Both verbal complaint and withdrawal of arm. Pain on injection was measured using scale as 0 no pain,1verbal complaint to pain,2 withdrawal of arm,3 both verbal complaint and withdrawal of arm

    Measured: 2 minutes after injection of study drug.

  2. Myoclonic movements

    Using Myoclonus scale as 0.No myoclonic movement. I. Minor myoclonic movement. II. Moderate myoclonic movement. III. Major myoclonic

    Measured: 60 seconds after injection of study drug

  3. Thrombophlebitis

    Presence or absence of inflammation of vein through which the drug was injected.

    Measured: 24 hours postoperatively

Timeline

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

  1. First posted21 Jun 2016 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

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 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02807610
Sponsor's protocol ID
PS/IEC-HR/DISS/38
Acronym
Induction
Status last verified
Jun 2016
First submitted
9 Jun 2016
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data will be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inj Etomidate and Injection Propofol in people with Hemodynamics and Side Effects, run by Maharashtra University of Health Sciences.

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 2 inclusion and 3 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Heart rate per minute (time frame: Change in Heart rate per minute from baseline value every five minutes for 30 minutes.). The study lists 2 primary outcomes in all. 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 NCT02807610.

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 21 Jun 2016.

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