General Anesthesia, Intravenous Anesthesia
Conditions
Keywords
Intravenous Anesthesia, General Anesthesia
Brief summary
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.
Detailed description
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: 1. Lidocaine 50 mg in a 10 cc syringe 2. Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe 3. 0.9% saline in a 10 cc syringe 4. Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe 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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* All adults American Society of Anesthesiologists (ASA) physical status 1 and 2 patients selected for general anesthesia.
Exclusion criteria
* age \< 18 years * allergy to local anesthetics * end stage renal disease * pregnancy * prisoners * patients requiring a rapid sequence induction * refusal to participate and patients already participating in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Pain With Injection of Propofol | Approximately 10 seconds following administration 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). |
| Number of Patients With Pain Associated With Injection of Propofol. | < 1 minute. | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between 6/2011 and 10/2011.
Pre-assignment details
200 participants were consented. The participants were distributed between the groups as follows, 39 participants in the control group, 38 in the lidocaine group, 44 in the magnesium group, and 37 in the magnesium/lidocaine group. Participants did not receive study drug if ASA score or peripheral IV inserted was not a 20 gauge.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Lidocaine 50 mg in a 10 cc syringe | 38 |
| Magnesium Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe | 44 |
| Lidocaine/Magnesium Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe | 37 |
| Control 0.9% saline in a 10 cc syringe | 39 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 12 | 6 | 13 | 11 |
Baseline characteristics
| Characteristic | Magnesium | Lidocaine/Magnesium | Lidocaine | Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 3 Participants | 8 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 33 Participants | 35 Participants | 31 Participants | 140 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 17.2 | 44.3 years STANDARD_DEVIATION 16.2 | 45.4 years STANDARD_DEVIATION 15.3 | 45.3 years STANDARD_DEVIATION 18.6 | 45.1 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment United States | 44 participants | 37 participants | 38 participants | 39 participants | 158 participants |
| Sex: Female, Male Female | 21 Participants | 14 Participants | 22 Participants | 14 Participants | 71 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 16 Participants | 25 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 50 | 25 / 50 | 15 / 50 | 18 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Number of Patients With Pain Associated With Injection of Propofol. | 11 participants reporting pain |
| Magnesium | Number of Patients With Pain Associated With Injection of Propofol. | 25 participants reporting pain |
| Lidocaine/Magnesium | Number of Patients With Pain Associated With Injection of Propofol. | 15 participants reporting pain |
| Control | Number of Patients With Pain Associated With Injection of Propofol. | 18 participants reporting pain |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Percentage of Participants Reporting Pain With Injection of Propofol | 29 percentage of patients reporting pain |
| Magnesium | Percentage of Participants Reporting Pain With Injection of Propofol | 57 percentage of patients reporting pain |
| Lidocaine/Magnesium | Percentage of Participants Reporting Pain With Injection of Propofol | 41 percentage of patients reporting pain |
| Control | Percentage of Participants Reporting Pain With Injection of Propofol | 46 percentage of patients reporting pain |