HypertensionPhase 4NCT06557473
Lidocaine Versus Fentanyl for Hemodynamic Stability
A Phase 4 study testing Lidocaine IV and Fentanyl in people with Hypertension and Fentanyl, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Fentanyl, Lidocaine
- What is being tested?
- Lidocaine IV and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Jul 2024
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA II, Hypertensive patients with the following criteria:
- Diagnosed with hypertension more than 5 years and on continuous medications.
- Controlled hypertension (systolic pressure < 140 mm Hg and the diastolic < 90 mm Hg).
- Age: 18-60 years of both sexes.
- Elective non cardiac surgery requiring general anesthesia.
Who cannot join
- Uncontrolled hypertension (SPB > 140 mm Hg) OR (DBP < 90 mm HG).
- SVV (stroke volume variability) ≥ 13.
- Patients with suspected difficult intubation as judged by the attending anesthetist during the preoperative assessment and patients for whom an alternative device other than an endotracheal tube will be considered.
- Pregnancy.
- History of drug abuse.
- Obese patients (BMI ≥ 35kg/m2).
- Allergy to any of the used medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Stability of Fentanyl Based Versus Lidocaine Based Induction of Anesthesia in Hypertensive Adults
Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. arterial hypotension defined as hypotension during the first 20 min after anesthesia induction, or from anesthesia induction until the beginning of surgery) and 'early intraoperative hypotension' (eIOH; i.e. arterial hypotension occurring during the first 30 min of surgery). Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
Read the detailed description
Since post induction hypotension is mainly caused by anesthetic drugs, developing a technique for the induction of anesthesia that provides adequate hypnosis with stable hemodynamics during surgery is critical, especially for hypertensive patients. (4) Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. (5) Opioid drugs are usually added to propofol to potentiate its hypnotic effect; however, they also potentiate propofol's negative hemodynamic effect at the same degree, even with low doses of propofol (5).
Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. (6) Lidocaine/ketamine combination showed a favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients [14]. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
- Conditions
- Hypertension, Fentanyl, Lidocaine
- Being tested
- Lidocaine IV, Fentanyl
- Keywords
- Hypertension, Postinduction hypotension, Lidocaine, Fentanyl
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
1.5mg/kg IV for induction of GA
FentanylDrug
Fentanyl IV 2 µg/kg for GA induction
| Study group | Role | What they receive |
|---|---|---|
| The lidocaine group | Active comparator | Anesthesia will be induced using 1.5 mg/kg lidocaine in the lidocaine group (L), 2mg/kg propofol, and 0.5 mg atracurium. Receives: Drug: Lidocaine IV |
| The fentanyl group | Placebo comparator | Anesthesia will be induced using 2 µg/kg fentanyl in the fentanyl group (F), 2mg/kg propofol, and 0.5 mg atracurium. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP
Mean Arterial blood pressure 1 minute after induction of anesthesia.
Measured: 1 minute after GA induction
Secondary outcomes (1)
Number of hypotensive episodes
MAP less than 65 mmHg.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Apr 2023
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison of lidocaine and fentanyl in hemodynamic stability after induction of general anesthesia in hypertensive patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshira sayed mohamed, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557473
- Sponsor's protocol ID
- PT (812)
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available upon request from the principal investigator
Publications
Yancey R. Anesthetic Management of the Hypertensive Patient: Part II. Anesth Prog. 2018 Fall;65(3):206-213. doi: 10.2344/anpr-65-03-17.
PubMed 30235430Aissaoui Y, Jozwiak M, Bahi M, Belhadj A, Alaoui H, Qamous Y, Serghini I, Seddiki R. Prediction of post-induction hypotension by point-of-care echocardiography: A prospective observational study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101090. doi: 10.1016/j.accpm.2022.101090. Epub 2022 May 1.
PubMed 35508291Hu AM, Qiu Y, Zhang P, Zhao R, Li ST, Zhang YX, Zheng ZH, Hu BL, Yang YL, Zhang ZJ. Higher versus lower mean arterial pressure target management in older patients having non-cardiothoracic surgery: A prospective randomized controlled trial. J Clin Anesth. 2021 May;69:110150. doi: 10.1016/j.jclinane.2020.110150. Epub 2021 Jan 6.
PubMed 33418429
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Stability of Fentanyl Based Versus Lidocaine Based Induction of Anesthesia in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT06557473
- Acronym / sponsor ID
- PT (812)
- Conditions
- Hypertension, Fentanyl, Lidocaine
- Keywords
- Hypertension, Postinduction hypotension, Lidocaine, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Aug 2024 (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.
Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. arterial hypotension defined as hypotension during the first 20 min after anesthesia induction, or from anesthesia induction until the beginning of surgery) and 'early intraoperative hypotension' (eIOH; i.e. arterial hypotension occurring during the first 30 min of surgery). Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
Detailed description
Since post induction hypotension is mainly caused by anesthetic drugs, developing a technique for the induction of anesthesia that provides adequate hypnosis with stable hemodynamics during surgery is critical, especially for hypertensive patients. (4) Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. (5) Opioid drugs are usually added to propofol to potentiate its hypnotic effect; however, they also potentiate propofol's negative hemodynamic effect at the same degree, even with low doses of propofol (5).
Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. (6) Lidocaine/ketamine combination showed a favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients [14]. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison of lidocaine and fentanyl in hemodynamic stability after induction of general anesthesia in hypertensive patients.
| Arm | Type | Receives |
|---|---|---|
| The lidocaine group | Active comparator | Drug: Lidocaine IVAnesthesia will be induced using 1.5 mg/kg lidocaine in the lidocaine group (L), 2mg/kg propofol, and 0.5 mg atracurium. |
| The fentanyl group | Placebo comparator | Drug: FentanylAnesthesia will be induced using 2 µg/kg fentanyl in the fentanyl group (F), 2mg/kg propofol, and 0.5 mg atracurium. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA II, Hypertensive patients with the following criteria:
- Age: 18-60 years of both sexes.
- Elective non cardiac surgery requiring general anesthesia.
Key exclusion criteria (7 listed)
- Uncontrolled hypertension (SPB > 140 mm Hg) OR (DBP < 90 mm HG).
- SVV (stroke volume variability) ≥ 13.
- Patients with suspected difficult intubation as judged by the attending anesthetist during the preoperative assessment and patients for whom an alternative device other than an endotracheal tube will be considered.
- Pregnancy.
- History of drug abuse.
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 |
|---|---|---|
| Lidocaine IV1.5mg/kg IV for induction of GA | Drug | The lidocaine group |
| FentanylFentanyl IV 2 µg/kg for GA induction | Drug | The fentanyl group |
Primary outcome
MAP
Time frame: 1 minute after GA induction
Mean Arterial blood pressure 1 minute after induction of anesthesia.
1 secondary outcome
Number of hypotensive episodes
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 30235430Yancey R. Anesthetic Management of the Hypertensive Patient: Part II. Anesth Prog. 2018 Fall;65(3):206-213. doi: 10.2344/anpr-65-03-17.
- Background: PubMed 35508291Aissaoui Y, Jozwiak M, Bahi M, Belhadj A, Alaoui H, Qamous Y, Serghini I, Seddiki R. Prediction of post-induction hypotension by point-of-care echocardiography: A prospective observational study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101090. doi: 10.1016/j.accpm.2022.101090. Epub 2022 May 1.
- Background: PubMed 33418429Hu AM, Qiu Y, Zhang P, Zhao R, Li ST, Zhang YX, Zheng ZH, Hu BL, Yang YL, Zhang ZJ. Higher versus lower mean arterial pressure target management in older patients having non-cardiothoracic surgery: A prospective randomized controlled trial. J Clin Anesth. 2021 May;69:110150. doi: 10.1016/j.jclinane.2020.110150. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No. data will be available upon request from the principal investigator
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lidocaine IV and Fentanyl in people with Hypertension and Fentanyl, run by Theodor Bilharz Research Institute 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 5 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 23 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
MAP (time frame: 1 minute after GA induction). 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 NCT06557473, which also lists 3 linked publications.
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 23 Aug 2024.