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Post Induction HypotensionNCT05462847

Comparing the Hemodynamic Effects of Volume Loading vs Non-loading During Induction of Anesthesia in Fluid Responder Patients With Coronary Artery Disease Undergoing Elective Coronary Artery Bypass Graft Surgery: a Randomized Controlled Study.

A study testing Ringer acetate in people with Post Induction Hypotension, run by Kasr El Aini Hospital at 1 site in Egypt.

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

All preoperative cardiac medications will be continued till the morning of the surgery, except angiotensin converting enzyme inhibitors. Patients will be pre-medicated with intramuscular morphine at 0.1 mg.kg-1 one hour before surgery. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Post Induction Hypotension
What is being tested?
Ringer acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 May 2021to 1 May 2022
Phase
Interventional
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
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients with coronary artery disease ASA physical status III-IV scheduled for elective CABG surgery.

Who cannot join

  • • left ventricular systolic dysfunction (LVSD) <40%,
  • persistent serious arrhythmias,
  • congestive cardiac failure, on mechanical ventilation,
  • intra-aortic balloon pump (IABP),
  • emergency surgery,
  • un controlled diabetes (HbA1C >8)
  • those with known allergy to any of the study's drugs,
  • severe systemic non-cardiac disease,

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Al Ainy

    Cairo, 12566

Other trials in Egypt

About this study

All preoperative cardiac medications will be continued till the morning of the surgery, except angiotensin converting enzyme inhibitors. Patients will be pre-medicated with intramuscular morphine at 0.1 mg.kg-1 one hour before surgery. Upon arrival to the operating room, Initial monitoring included five lead electrocardiograms, non-invasive blood pressure, and pulse oximetry. At the attending anesthetists discretion, intravenous midazolam (0.05 mg/kg) will be administered for anxiolysis. Under local anesthesia an arterial line will be placed in the right radial artery and central venous line will be placed in the right internal jugular vein.

Before induction of anesthesia for all study patients, Electrical cardiometry device (ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4 electrodes at the following sites: Below the left ear, Above the midpoint of the left clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the third electrode. Stroke volume variability (SVV) was measured while patient maintaining standard calm breathing at 8 breath/minute for one-minute. Patients with SVV less than 13% will be excluded from the study. Thus, all patients included will be considered fluid responders[5]. The baseline data in the form of heart rate, systolic, diastolic, and mean systemic arterial pressures, CO, CI, SV, SVI, SVV, SVR, and SVRI will be recorded during the study period in all the patients.

Read more

Patients will then be randomly divided into two groups; control group will receive nothing before induction, while patients in volume loading group will receive volume loading of 8ml/kg Ringer acetate over 10 minutes. The volume loading will be repeated until SVV would be below 13%. The volume loading would be given by an anesthesia resident not involved in data collection.

For induction, Patients in both groups will receive 3 mcg/kg of fentanyl. Then in all patients, propofol will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments every 20 s till clinical loss of consciousness. Clinical loss of consciousness (defined as no response to auditory command) will be assessed by asking the patients repeatedly every 20 s to open their eyes. After loss of consciousness, atracurium 0.5 mg/kg will be administered to facilitate tracheal intubation. The stress response to laryngoscopy and tracheal intubation is secondary to marked increase in sympathetic activity and manifested in general as tachycardia and hypertension and will be managed with increments 0..25mcg fentanyl. Hemodynamic changes; 20 beats/ minute or 20 mmHg difference in heart rate and blood pressure respectively were considered to be significant. Anesthesia will be maintained by isoflurane (1-1.2 %). Patients will be mechanically ventilated to have target of PO2 above 300mmhg and PCO2 between 35-40mmg.

Any episode of hypotension (defined as mean arterial pressure [MAP] < 80% of the baseline reading and/or MAP <60 mmHg) will be managed by 5 mcg norepinephrine (which could be repeated if hypotension persists for 2 minutes).

If bradycardia occurred (defined as heart rate less than 50 bpm), it will be managed by IV atropine bolus (0.5 mg).

Hemodynamic data will be recorded 1-minte before the induction, 1-and 2-minutes after loss of consciousness, 1-minutes after intubation, then every 2-minutes for 15-minutes after intubation., the end point of the present study. Throughout this period the lungs will be mechanically ventilated with 50% air-oxygen mixture, to maintain an end-tidal carbon dioxide between 35 and 40 mmHg.

Being tested
Ringer acetate

What participants receive

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

  • Ringer acetateDrug

    8ml/kg Ringer acetate over 10 minutes

Study groups in NCT05462847
Study groupRoleWhat they receive
Volume loadingExperimentalNot described
Receives: Drug: Ringer acetate
ControlActive comparatorNot described
Receives: Drug: Ringer acetate

What is being measured

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

  1. Incidence of post-induction hypotension

    Incidence of post-induction hypotension from start of induction of anesthesia till 15-minutes

    Measured: 15 minutes

Secondary outcomes (1)
  1. Incidence of post-induction hypertension, bradycardia, and tachycardia

    Incidence of post-induction hypertension, bradycardia, and tachycardia

    Measured: 15 minutes

Timeline

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

  1. First posted18 Jul 2022
  2. Study start1 May 2021
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05462847
Sponsor's protocol ID
MS-618-2021
Status last verified
Jul 2022
First submitted
14 Jul 2022
Last updated
18 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Ringer acetate in people with Post Induction Hypotension, run by Kasr El Aini Hospital at 1 site in Egypt.

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 1 inclusion and 8 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 18 Jul 2022. 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 Egypt. 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.

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?

Incidence of post-induction hypotension (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Jul 2022.

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