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feasibility of enrollment
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The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | 1 mg/kg lidocaine to a max of 100 mg |
|
| Esmolol | Active Comparator | 0.5 mg/kg esmolol to a max of 50 mg |
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| Placebo | Placebo Comparator | Saline water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain Score | pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable | following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | heart rate is measured as numbers on a scale with normal 60-100 | heart rate is measured each minute for the first 10 minutes following induction |
| Systolic Blood Pressure | blood pressure measured in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Norton, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | 1 mg/kg lidocaine to a max of 100 mg Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| FG001 | Esmolol | 0.5 mg/kg esmolol to a max of 50 mg Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| FG002 | Placebo | Saline water Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | 1 mg/kg lidocaine to a max of 100 mg Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| BG001 | Esmolol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Pain Score | pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction |
|
10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | 1 mg/kg lidocaine to a max of 100 mg Lidocaine: 1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Norton, MD | Wake Forest University Health Sciences | 336-716-8791 | mnorton@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2022 | Aug 9, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2022 | Oct 5, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C036604 | esmolol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
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assessor asking for pain scores will be blinded from the randomization
| Esmolol | Drug | 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
|
| Placebo | Other | saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
|
| Systolic Blood Pressure is measured each minute for the first 10 minutes following induction |
| Oxygen Saturation Percentage | oxygen saturation is measured on a percentage, with normal range >90% | Oxygen saturation measured each minute for the first 10 minutes following induction |
0.5 mg/kg esmolol to a max of 50 mg Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| BG002 | Placebo | Saline water Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used | Count of Participants | Participants |
|
| Race (NIH/OMB) | PIV in location that was excluded, surgery cancelled BMI exclusion, surg cx, exclusionary med to be used exclusionary med to be used | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG002 | Placebo | Saline water Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. |
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| Secondary | Heart Rate | heart rate is measured as numbers on a scale with normal 60-100 | Posted | Mean | Standard Deviation | beats per minute | heart rate is measured each minute for the first 10 minutes following induction |
|
|
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| Secondary | Systolic Blood Pressure | blood pressure measured in mmHg | Posted | Mean | Standard Deviation | mm Hg (millimeters of mercury) | Systolic Blood Pressure is measured each minute for the first 10 minutes following induction |
|
|
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| Secondary | Oxygen Saturation Percentage | oxygen saturation is measured on a percentage, with normal range >90% | Posted | Mean | Standard Deviation | percentage | Oxygen saturation measured each minute for the first 10 minutes following induction |
|
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Esmolol | 0.5 mg/kg esmolol to a max of 50 mg Esmolol: 0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Placebo | Saline water Placebo: saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | 0 | 6 | 0 | 6 | 0 | 6 |
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| Aniline Compounds |
| D000588 | Amines |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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