A Phase 4 interventional study of Magnesium Sulfate and Lidocaine in General Anesthesia and Intravenous Anesthesia, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
Since the introduction of propofol into routine anesthesia practice, the phenomena of pain on injection has plagued anesthesia providers. Propofol, an unstable phenol, triggers the release of bradykinin on injection. This release causes a painful burning sensation in the patient at the site of injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. Currently, pretreatment with lidocaine is commonly administered to prevent propofol injection pain. No studies to date have looked at the combination of lidocaine and magnesium in a single syringe for the pretreatment of pain on injection caused by propofol. In addition, the administration protocols that have been studied thus far do not mirror clinical practice at the University of Wisconsin. The investigators propose studying the use of magnesium and lidocaine in a single syringe for pretreatment of propofol related pain on injection.
This study will involve little if any change from the typical induction of general anesthesia. Considering that lidocaine is routinely used for the induction of anesthesia, and that some anesthesia staff also inject magnesium prior to propofol, there will be little variation in the induction of anesthesia. Patients will be randomly assigned (by microsoft excel program providing a random number 1-4) to one of four groups:
Study drugs will be prepared in identical syringes by the Pharmaceutical Research Center (PRC). Study personnel will receive a syringe labeled with the study number as well as a data collection sheet labeled with the study number. A 20 gauge angiocatheter will be inserted into the dorsum of the hand for IV fluids and medication administration. Subjects will be given preoperative 1-2 mg intravenous midazolam for sedation when the subject is en route to the operating room as is typically done at the discretion of the anesthesia provider caring for the patient. After instituting standard monitors and providing preoxygenation, the study drug will be injected. Twenty seconds later, 50 mg of propofol will be injected. Ten seconds after infusion of propofol, the subjects will then be asked a standard question about pain on injection "Are you having pain at your IV site?". Any behavioral signs such as facial grimacing, arm withdrawal, or tears will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears). Study key personnel will do these pain assessments; the behavioral signs and self-reporting of pain will be recorded separate from one another. The induction of anesthesia will then by completed with the appropriate amount of propofol. Formally assessing pain following injection is not something that is standard care but all patients are currently warned prior to injection that they may experience some warmth or burning at the site of their intravenous line.
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lidocaine 50 mg in a 10 cc syringe
Drug: Magnesium Sulfate · Drug: Lidocaine
Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
Drug: Magnesium Sulfate
Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
Drug: Magnesium Sulfate · Drug: Lidocaine/Magnesium
0.9% saline in a 10 cc syringe
Drug: Magnesium Sulfate · Drug: Control
We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
Percentage of Participants Reporting Pain With Injection of Propofol
Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).
Time frame: Approximately 10 seconds following administration of propofol.
Number of Patients With Pain Associated With Injection of Propofol.
Ten seconds following injection of propofol, subjects were asked "Are you having pain at your IV site?" Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).
Time frame: < 1 minute.
Participants were recruited between 6/2011 and 10/2011.
| Milestone | Lidocaine | Magnesium | Lidocaine/Magnesium | Control |
|---|---|---|---|---|
| Started | 50 | 50 | 50 | 50 |
| Completed | 38 | 44 | 37 | 39 |
| Not completed | 12 | 6 | 13 | 11 |
| Withdrew: Protocol violation | 12 | 6 | 13 | 11 |
Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).
| percentage of patients reporting pain | Lidocaine | Magnesium | Lidocaine/Magnesium | Control |
|---|---|---|---|---|
| Percentage of Participants Reporting Pain With Injection of Propofol | 29 (17 to 45) | 57 (42 to 70) | 41 (26 to 56) | 46 (32 to 61) |
Ten seconds following injection of propofol, subjects were asked "Are you having pain at your IV site?" Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).
| participants reporting pain | Lidocaine | Magnesium | Lidocaine/Magnesium | Control |
|---|---|---|---|---|
| Number of Patients With Pain Associated With Injection of Propofol. | 11 | 25 | 15 | 18 |
Collected over Less than one minute following injection in intravenous propofol.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lidocaine | — | 0/50 (0%) | 11/50 (22%) |
| Magnesium | — | 0/50 (0%) | 25/50 (50%) |
| Lidocaine/Magnesium | — | 0/50 (0%) | 15/50 (30%) |
| Control | — | 0/50 (0%) | 18/50 (36%) |
| Event | Lidocaine | Magnesium | Lidocaine/Magnesium | Control |
|---|---|---|---|---|
| Pain with injection of propofolGeneral disorders | 11/50 | 25/50 | 15/50 | 18/50 |
| Age, Categorical(Participants) | Lidocaine | Magnesium | Lidocaine/Magnesium | Control | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 41 | 33 | 31 | 140 |
| >=65 years | 3 | 3 | 4 | 8 | 18 |
| Age, Continuous(years) | Lidocaine | Magnesium | Lidocaine/Magnesium | Control | Total |
|---|---|---|---|---|---|
| Mean | 45.4 ± 15.3 | 44.4 ± 17.2 | 44.3 ± 16.2 | 45.3 ± 18.6 | 45.1 ± 16.5 |
| Sex: Female, Male(Participants) | Lidocaine | Magnesium | Lidocaine/Magnesium | Control | Total |
|---|---|---|---|---|---|
| Female | 22 | 21 | 14 | 14 | 71 |
| Male | 16 | 23 | 23 | 25 | 87 |
| Region of Enrollment(participants) | Lidocaine | Magnesium | Lidocaine/Magnesium | Control | Total |
|---|---|---|---|---|---|
| United States | 38 | 44 | 37 | 39 | 158 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Wisconsin, Madison