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.
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
- Recruiting
Kasr Alaini Hospital
Cairo, 11562
Anesthesia, Pain Management and Surgical ICU Department, 00201222224057, Anesthesia.kasralainy@gmail.com
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)}
- Conditions
- Postinduction Hypotension, Elderly
- 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 group | Role | What they receive |
|---|---|---|
| fentanyl group | Active comparator | Not described Receives: Drug: fentanyl |
| lidocaine group | Active comparator | Not described Receives: Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
total norepinephrine dose
mcg
Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
Secondary outcomes (8)
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
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
Incidence of hypertension
mean arterial pressure 120% of baseline
Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
tachycardia
heart rate >120% of baseline
Measured: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
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
total propofol dose
mg/kg
Measured: 1 second after starting drug injection until one second after loss of consciousness
intubation time
second
Measured: 1 second after insertion of direct laryngoscopy into the mouth till one second after its removal after tracheal intubation
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.
- First posted21 Sep 2021
- Study start1 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postinduction HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hemodynamic Effects of Opioid-based Versus Lidocaine-based Induction of Anesthesia With Propofol in Elderly: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05051007
- Acronym / sponsor ID
- MD-239-2021
- Conditions
- Postinduction Hypotension, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
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)}
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl group | Active comparator | Drug: fentanyl |
| lidocaine group | Active comparator | Drug: Lidocaine IV |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists I-III,
- scheduled for elective non-cardiac surgery under general anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanylpatients will receive 1 mcg/kg of fentanyl (the drug will be diluted to 10 mcg/mL) | Drug | fentanyl group |
| Lidocaine IVpatients will receive 1 mg/kg lidocaine (the drug will be diluted to10mg/mL) | Drug | lidocaine group |
Primary outcome
total norepinephrine dose
Time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
mcg
8 secondary outcomes
Incidence of post-induction hypotension
Time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
Incidence of severe post-induction hypotension
Time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
Incidence of hypertension
Time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
tachycardia
Time frame: 1 minute after induction of anesthesia until 15 minutes after induction or surgical incision
loss consciousness time
Time frame: 1 second after starting drug injection until one second after loss of consciousness
total propofol dose
Time frame: 1 second after starting drug injection until one second after loss of consciousness
intubation time
Time frame: 1 second after insertion of direct laryngoscopy into the mouth till one second after its removal after tracheal intubation
incidence of postoperative delirium
Time frame: at 24 and 48 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.