AzTrials
AzTrials

Postinduction HypotensionPhase 4NCT05051007

Opioid-based Versus Lidocaine-based Induction of Anesthesia With Propofol in Elderly

A Phase 4 study testing fentanyl and Lidocaine IV in people with Postinduction Hypotension and Elderly, run by Kasr El Aini Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Advances in the medical service and public health increased longevity; hence, more elderly patients (>65 years) are encountered by the anesthetists for variety of surgical interventions. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Postinduction Hypotension, Elderly
What is being tested?
fentanyl and Lidocaine IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Oct 2021to Dec 2022
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American society of anesthesiologists I-III,
  • scheduled for elective non-cardiac surgery under general anesthesia

Who cannot join

  • Patients with severe cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions, metabolic equivalent less than 4),
  • patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications,
  • patients with uncontrolled hypertension,
  • patients with body mass index <18 or > 35 Kg/m2,
  • patient with allergy of any of the study drugs

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Kasr Alaini Hospital

    Cairo, 11562

    Anesthesia, Pain Management and Surgical ICU Department, 00201222224057, Anesthesia.kasralainy@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Comparison of the Hemodynamic Effects of Opioid-based Versus Lidocaine-based Induction of Anesthesia With Propofol in Elderly: A Randomized Controlled Study

Advances in the medical service and public health increased longevity; hence, more elderly patients (>65 years) are encountered by the anesthetists for variety of surgical interventions. Even with the absence of comorbidity, older patients represent a challenge to the anesthetist in comparison to the younger patients due to their limited physiologic reserve and their aberrant response to the varies perioperative medications.

Intraoperative hypotension increases the risk of postoperative kidney injury, myocardial injury, cerebral ischemia, and perioperative mortality. Postinduction hypotension is mainly caused by anesthetic drugs. Hence, developing a technique for induction of anesthesia that provide adequate hypnosis with stable hemodynamics during surgery is critical, especially for elderly patients. The elderly patients are at increased risk of post-induction hypotension due to increased drug sensitivity.

Read more

Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. Opioid drugs are usually added as analgesics to propofol during induction of anesthesia. However, addition of opioids to propofol potentiates the risk of postinduction hypotension. Furthermore, opioids increase the risk of postoperative delirium in elderly patients and this risk is further increased with intraoperative hypotension.

Lidocaine is a local anesthetic drug with multiple systemic uses. Lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during procedural sedation. Lidocaine/ketamine combination showed favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients. Therefore, the use of lidocaine as an adjuvant to propofol might provide a stable cardiovascular profile during induction of anesthesia in elderly compared to fentanyl. To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with propofol in elderly

Read the detailed description

Upon arrival to the operating room, patient's airway will be assessed by trained anesthetist (modified Mallampati test, mouth opening, jaw protrusion, thyromental height, neck extension, dentation). If the patient is considered to be difficult and alternative device other than endotracheal tube is considered, the patients will be excluded. Routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications {ranitidine 50 mg, dexamethasone 4 mg (0.5 mg/ml slow I.V injection)} will be administrated. Baseline preoperative blood pressure will be recorded form the preoperative visit in the supine position as average of 3 readings with difference less than 5 mmHg.

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 ≥ 13% will be considered fluid responder and will receive a fluid bolus of 8 mL/kg Ringer acetate over 10 minutes. The fluid bolus will be repeated until the SVV is less than 13%.

Patients will be allocated into two groups: lidocaine group and fentanyl group. In all patients, propofol will be injected slowly in 0.25 mg/kg increments every 20 s till clinical loss of consciousness or reaching a maximum dose of 1-1.5 mg/kg in addition to the study drug. Clinical loss of consciousness (defined as no response to auditory command and disappearance of a patient's eyelash reflex) will be assessed by asking the patients repeatedly every 10 s to open their eyes, when there is no response to auditory commands, the eyelid reflex will be tested. After loss of consciousness, rocuronium (0.6 mg/kg) will be administered, and anesthesia will be maintained by isoflurane (0.9-1% end-tidal). Endotracheal tube will be inserted after 2-minutes of mask ventilation. Ringer lactate solution will be infused at a rate of 2 mL/kg/hour. If the patient did not achieve adequate hypnosis, an additional bolus of propofol (0.5 mg/kg) will be administered.

Any episode of hypotension (defined as mean arterial pressure ≤ 70% of the baseline reading and/or mean arterial pressure <60 mmHg) will be managed by 5 mcg norepinephrine (which can be repeated if hypotension persisted for 2 minutes).

Severe post-induction hypotension defined as mean arterial pressure ≤60% of baseline, will be managed by 5 mcg norepinephrine and the blood pressure will be measure at 1-min interval. Norepinephrine bolus will be repeated if severe hypotension persisted for 1-minute.

If bradycardia occurred (defined as heart rate less than 45 bpm), it will be managed by IV atropine bolus (0.5 mg).

After skin incision, hemodynamic and anesthetic management will be according to the attending anesthetist discretion.

Postoperative Confusion assessment method (CAM) assessment will be performed by trained research member at and 24- and 48-hours after surgery. CAM will be assessed through a four-step algorithm identifying the following: 1) acute onset of mental status changes or a fluctuating course, 2) inattention, 3) disorganized thinking, 4) an altered level of consciousness. Patients will be diagnosed to be delirious if both features {(1) and (2)} will be present plus either feature (3) or (4)}

Being tested
fentanyl, Lidocaine IV

What participants receive

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

  • fentanylDrug

    patients will receive 1 mcg/kg of fentanyl (the drug will be diluted to 10 mcg/mL)

  • Lidocaine IVDrug

    patients will receive 1 mg/kg lidocaine (the drug will be diluted to10mg/mL)

Study groups in NCT05051007
Study groupRoleWhat they receive
fentanyl groupActive comparatorNot described
Receives: Drug: fentanyl
lidocaine groupActive comparatorNot described
Receives: Drug: Lidocaine IV

What is being measured

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

  1. total norepinephrine dose

    mcg

    Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

Secondary outcomes (8)
  1. Incidence of post-induction hypotension

    mean arterial pressure ≤70% of baseline or < 60 mmHg

    Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

  2. Incidence of severe post-induction hypotension

    mean arterial pressure ≤60% of baseline

    Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

  3. Incidence of hypertension

    mean arterial pressure 120% of baseline

    Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

  4. tachycardia

    heart rate >120% of baseline

    Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

  5. loss consciousness time

    time to achieve no response to auditory command and disappearance of a patient's eyelash reflex

    Measured: 1 second after starting drug injection until one second after loss of consciousness

  6. total propofol dose

    mg/kg

    Measured: 1 second after starting drug injection until one second after loss of consciousness

  7. intubation time

    second

    Measured: 1 second after insertion of direct laryngoscopy into the mouth till one second after its removal after tracheal intubation

  8. incidence of postoperative delirium

    Confusion assessment method will be assessed through a four-step algorithm identifying the following: 1) acute onset of mental status changes or a fluctuating course, 2) inattention, 3) disorganized thinking, 4) an altered level of consciousness. Patients will be diagnosed to be delirious if both features {(1) and (2)} will be present plus either feature (3) or (4)}

    Measured: at 24 and 48 hour 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 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05051007
Sponsor's protocol ID
MD-239-2021
Status last verified
Dec 2022
First submitted
10 Sep 2021
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fentanyl and Lidocaine IV in people with Postinduction Hypotension and Elderly, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 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.

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?

Results are not available in the source record.

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

Contact ahmed hasanin (01095076954, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total norepinephrine dose (time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision). 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 9 Dec 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in