The occurrence of myalgia’s vary within different groups of patients and it has generally understood that it occurs more frequently in women, for reasons yet not fully understood. Propofol has been shown in some studies to reduce the incidence of muscle fasciculations and postoperative myalgias, to a greater degree than with pretreatment alone. However, Smith et al.. (1993) concluded that Propofol did not significantly reduce the incidence of postoperative myalgia, however, the selection of an all female group may be a confounding factor in the results. The results of the studies in women effectively demonstrate a decreased occurrence of myalgias with the use of Propofol prior to succinylcholine. It could perhaps be concluded that the incidence would be further reduced in men and is the basis for selecting an all male group and controlling for this potential confounding factor.
Method
Research Question
This study seeks to determine the incidence and severity of fasciculations and myalgias associated with the administration of Succinylcholine. Is there an association between incidence and severity of fasciculation’s and myalgias and does the administration of Propofol or Pentothol reduce the occurance after rapid sequence inductions?
Design
This study design will be quasi-experimental in nature and will be a prospective, randomized, single-blinded design.
Population & Sample
The convenience sample will be obtained by reviewing the surgical schedule for the next day and selecting candidates that prospectively meet the criteria for inclusion. The study is open only to males with no restriction on ethnicity. ASA is the American Society of Anesthesiology risk categories that rates patients as healthy, ASA 1, to moribund, ASA 5. Inclusion criteria includes: Age 35 years and older, preoperative ASA classification of 1 through 3, Surgical procedure which requires general surgery with rapid sequence induction.
Exclusion criteria include: known hypersensitivity to Pentathol, Propofol or Succinylcholine; personal or familial history of malignant hyperthermia; patients undergoing emergency surgery, surgery of the neck and shoulder area, or laproscopic surgery of the abdomen; body weight deviations greater than 25% from ideal; known neuromuscular disorder; preexisting neck or shoulder discomfort: failure, inability or unwillingness to give informed consent. Patients that are unable to receive either Pentothol or Propofol in each case will not be included in the study.
Setting
The experimental study will be conducted at the Minneapolis Veterans Administration Medical Center. The treatment will be administered in the operating room. The subjects will be monitored using routine methods for ECG, blood pressure, oxygen saturation, temperature, muscle paralysis and end tidal carbon dioxide.
Measurements
Fasciculations
Fasciculations are the involuntary muscle activity observed after the administration of Succinylcholine. The rating of Muscle fasciculatio’s tool used will be a standardized numeric scale ranging from 0 through 3. Fasciculation’s will be observed by the anesthesia personnel administering the anesthetic. Criteria used to describe fasciculation’s will be described as: nil (0); fine tremors of the face and neck (1); moderate fasciculation’s affecting the neck and limbs (2); severe vigorous, widespread fasciculation’s (3). These conditions are ranked according to criteria similar to that used by Demers-Pelletier, etal.. (1997). No validity are given by raters for this measurement. However, a high level of rater reliability will be attained since the primary investigator will be present to observe each case.
The occurance of fasciculation’s will be monitored by the investigator by assessing for muscle tremors and contractions immediately following the administration of Succinylcholine until three minutes post administration. Succinylcholine is known to have a rapid onset, generally occurring at the 60 to 90 second mark. The observations will be rated and recorded on the standardized assessment tool.
Myalgia
Myalgia is the presence of muscle discomfort. May range from slight aching to pain that limits activities. In this study, the pain experienced purportedly caused by the administration of Succinylcholine. The rating of postoperative myalgia will be a subjective measure reported by the patient instructed in the scale measurement. The rating will be a standardized numeric scale ranging from 0 through 10. Patients will be contacted at 24 hours postoperatively and asked to rate their myalgia. Patients reporting no myalgia will rate a 0, increasing in intensity to 10. The neck and shoulders commonly exhibit symptoms of Succinylcholine induced muscle myalgia, and will be the area assessed for myalgia. Rater reliability will be attained since the primary investigator will contact and record the results in each case.
Design
Subjects will be randomized into two treatment groups using the last digit of their social security number (SSN). Subjects will be assigned to Group A if their SSN ends with zero through four. Subjects will be assigned to Group B is their SSN ends with five through nine. Both groups will receive a defaciculating dose of Rocuronium, being 10% of the induction dose, followed three minutes later by induction. Group A will begin induction by receiving 1.5 mg/kg to 2 mg/kg of Propofol, followed within 3 minutes by the administration of 1.5 mg/kg of Succinylcholine. Group B will begin induction by receiving 3 mg/kg to 5 mg/kg of Pentathol, followed within 3 minutes by receiving 1.5 mg/kg to 2 mg/kg of Succinylcholine.
The CRNA performing the anesthetic will conduct drug preparation after determining the group to which a given subject was assigned.
Proceedure
Subjects will be greeted in the operating room holding area. The investigator and the case CRNA will conduct the standard anesthetic preoperative interview. Criteria for exclusion will be addressed with the case CRNA, and the case anesthesiologist at that time. Patients will be informed of the study and consent will be attained if subjects agree to participate. An intravenous catheter will be placed in either arm.
Once consent has been attained, the subjects will be transported to the operating room. The standard monitoring devices will be placed on the subject. All subjects will routinely be medicated with 2mg of Midazolam and 3-5 CC of Fentanyl for sedation and amnesia prior to the administration of the defasciculating dose of Rocuronium. The usual induction will begin with preoxygenation, consisting of placing mask over the mouth and nose and applying 8-12 L/minute flow to the patient. All medications will be administered via the intravenous line as per usual routine.
Pretreatment is the intravenous administration of 10% of the calculated intubating dose of Rocuronium three minutes prior to administering Succinylcholine. Once the investigator and case anesthesia personnel are prepared for induction, a pretreatment is calculated as 10% of the intubating dose of Rocuronium and will be administered as the defasciculation dose. Patients are monitored at this time for any changes in breathing or muscle weakness. At the three minute mark, Group A will receive a bolus dose (1.5 mg/kg to 2 mg/kg) of Propofol, and Group B will receive a bolus dose of Pentathol (3mg/kg). Induction will proceed within 3 minutes with the administration of a bolus dose of Succinylcholine (1.5 mg/kg).
The usual rationale for utilizing either Pentathol or Propofol is based on the patients ability to hemodynamically withstand the depressant effects of these two agents. The usual circumstance allows for either agent to be utilized equally. Because of the occurance of vascular pain upon the injection of Propofol, the administration of Lidocaine (.0.5mg/kg) will be injected prior to administering Propofol. Lidocaine stabilizes membranes and could potentially affect the action of Succinylcholine. The use of Lidocaine will therefore be standardized at 0.5 mg/kg. Following the induction and intubation, the patients general anesthetic will be administered in the usual routine
The patient will be contacted by the investigator at 24 hours time. The patient will be asked to rate the presence of any muscle ache (myalgia) or pain in the neck and shoulders area. The patient will be asked to rate the intensity of myalgia on a scale of 0 to 10. The rating will be recorded on the standardized scale by the investigator.
Limitations
This study will follow the designs for quantitative comparison between two groups. Limitations are that quantitative measures are assigned to qualitative observations. Numbers can be satisfactorily applied to these measures, but different individuals my interpret the qualitative experience differently and therefore assign varied quantitative measures to similar events. All variables that may confound the data must be controlled. Confounding variables may be present without awareness and are subsequently uncontrolled. Results obtained from small groups may not have the power to detect real differences in groups. Dosing calculations or timing may not be exact and vary so as to confound the results. The drug properties may vary somewhat from lot to lot and alter therapeutic effects.
There are several limitations to this design, however, if methodology is followed closely, confounding variables may be sufficiently controlled. Anesthesia personnel understand the value of research and are competent enough to make precise calculations when administering drugs and can be entrusted to correctly follow study protocol.
Protection of Rights of Participants
Researchers are asking patients to participate in an experimental study. The patients are asked to listen to the study requirements, benefits and risks, and at such time they are satisfied with study issues, consent to enter the study. This study does not place patients at any greater risk of adverse effects than the current risk already in existence for their operative procedure and anesthetic administration. The medications administered to either of the groups are used routinely and are accepted anesthetics. The participants are not being forced or coerced to enter the study against their will. Risks are less than the benefits and it is concluded that this study adds no risk, and has the potential for benefiting future practice. The potential benefits gained through this study is the knowledge gained in administering anesthesia in a manner that reduces postoperative myalagia caused by the administration of Succinylcholine. It is theorized that the results of this study will provide information on the more efficacious course of action to minimize fasciculation’s and myalgias.
The patients will receive full disclosure before being asked to consent, and will be treated respectfully throughout the study and all results will remain confident in order to preserve the patients anonymity. Vulnerable subjects will not be considered for entry into the study without the consent of the legal guardian. This proposal will be presented to the Institutional Review Board for approval.
Patients will be screened for absolute contradictions for the study. Patients whom have demonstrated sensitivity to any of the drugs included within the study design will not be entered. Patients who are not cardiovascularly stable, and require induction with an agent with less hypotensive properties will not be considered. No patient’s anesthetic will be modified to facilitate this study so as to place the patient at increased risk. Participants in both groups will be given a drug that is directly responsible for fasciculation’s and myalgias, and no definitive treatment is being withheld that reduces the intensity.
Data Analysis Plan
A Chi square (X2) test for independence with frequencies for myalgias and fasciculations will be utilized. The mean, median and mode will be analyzed and presented.
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References
Demers-Pelletier, J., Drolet, P., Girard, J., & Donati, F. (1997). Comparison of rocuronium and d-tubocurarine for prevention of succinylcholine-induced fasciculations and myalgia. Canadian Journal of Anaesthesia, 44, 1144-1147.
Harvey, S. C., Roland, P., Bailey, M. K., Tomlin, M. K., & Williams, A. (1998). A randomized, double-blind comparison of rocuronium, d-tubocurarine, and “mini dose” succinylcholine for preventing succinylcholine-induced muscle fasciculations. Anesthesia & Analgesia, 87, 719-722.
Maddineni, V. R., Mirakhur, R. K., & Cooper, A. R. (1993). Myalgia and biochemical changes following suxamethonium after induction of anaesthesia with thiopentone or Propofol. Anaesthesia, 48, 626-628.
McClymont, C. (1994). A comparison of the effect of Propofol or thiopentone on the incidence and severity of suxamethonium-induced myalgia. Anaesthesia & Intensive Care, 22, 147-149.
Smith, I., Ding, Y., & White, P.F. (1993). Muscle pain after outpatient laproscopy–influence of Propofol versus thiopental and enflurane. Anesthesia & Analgesia, 76, 1811-1184.
Tsui, B. C., Reid, S., Gupta, S., Kearney, R., Mayson, T., & Finucane, B. (1998). A rapid precurarization technique using rocuronium. Canadian Journal of Anasthesia, 45, 397-401.
Variable Measurement Form
Height:__________ Age:____________
Weight:_________ ASA: ___________
Treatment Group A: 1.5 mg/kg-2 mg/kg Propofol
B: 3 mg/kg-5 mg/kg Pentothol
Pt Complaints after defasciculation dose: Dyspnea Muscle weakness Other:____________
Time of Bolus after defasciculation dose ( in minutes): 1 1.5 2 2.5 3 3.5
Drugs: Fentanyl (cc)__________ Versed (mg)__________ Lidocaine (mg/kg)_________
Propofol (mg/kg)________ Rocuronium (mg/kg):_________
Rating of Fasciculations
0 1 2 3
None Mild tremors of Moderate contractions Severe, vigorous and
Face and neck of the neck and/or limbs widespread
Rating Postoperative myalgia
Hours postoperative patient contacted:_______
0 1 2 3 4 5 6 7 8 9 10
None mild moderate severe
BIOSKETCH
Supply Budget
Supplies:
- copying costs, free to student at VA Hospital clinical site
- paper, free to student at Va Hospital clinical site
- transportation costs, incurred by student
- drug cost, supplied by clinical site anesthesia dept.
Time Line
4/2000 – Proposal complete
6/2000 – Submit proposal packet to University of Minnesota advisor and VA hospital IRB
8/2000 – Conduct research
9/2000 – Compile data, analyze findings
10/2000 – Complete plan B
Bibliography
References
Demers-Pelletier, J., Drolet, P., Girard, J., & Donati, F. (1997). Comparison of rocuronium and d-tubocurarine for prevention of succinylcholine-induced fasciculations and myalgia. Canadian Journal of Anaesthesia, 44, 1144-1147.
Harvey, S. C., Roland, P., Bailey, M. K., Tomlin, M. K., & Williams, A. (1998). A randomized, double-blind comparison of rocuronium, d-tubocurarine, and “mini dose” succinylcholine for preventing succinylcholine-induced muscle fasciculations. Anesthesia & Analgesia, 87, 719-722.
Maddineni, V. R., Mirakhur, R. K., & Cooper, A. R. (1993). Myalgia and biochemical changes following suxamethonium after induction of anaesthesia with thiopentone or Propofol. Anaesthesia, 48, 626-628.
McClymont, C. (1994). A comparison of the effect of Propofol or thiopentone on the incidence and severity of suxamethonium-induced myalgia. Anaesthesia & Intensive Care, 22, 147-149.
Smith, I., Ding, Y., & White, P.F. (1993). Muscle pain after outpatient laproscopy–influence of Propofol versus thiopental and enflurane. Anesthesia & Analgesia, 76, 1811-1184.
Tsui, B. C., Reid, S., Gupta, S., Kearney, R., Mayson, T., & Finucane, B. (1998). A rapid precurarization technique using rocuronium. Canadian Journal of Anasthesia, 45, 397-401.
Variable Measurement Form
Height:__________ Age:____________
Weight:_________ ASA: ___________
Treatment Group A: 1.5 mg/kg-2 mg/kg Propofol
B: 3 mg/kg-5 mg/kg Pentothol
Pt Complaints after defasciculation dose: Dyspnea Muscle weakness Other:____________
Time of Bolus after defasciculation dose ( in minutes): 1 1.5 2 2.5 3 3.5
Drugs: Fentanyl (cc)__________ Versed (mg)__________ Lidocaine (mg/kg)_________
Propofol (mg/kg)________ Rocuronium (mg/kg):_________
Rating of Fasciculations
0 1 2 3
None Mild tremors of Moderate contractions Severe, vigorous and
Face and neck of the neck and/or limbs widespread
Rating Postoperative myalgia
Hours postoperative patient contacted:_______
0 1 2 3 4 5 6 7 8 9 10
None mild moderate severe
BIOSKETCH
Education
MS (2001) Nursing (Plan B: Nurse Anesthesia)
University of Minnesota, Minneapolis
BS 1997 Nursing
University of Arkansas for Medical Sciences, Little Rock
Professional Employment
1999 Student Registered Nurse Anesthestist, Anesthesia Dept.
Veterans Affairs Hospital, Minneapolis, MN
1997-99 Staff Nurse, Surgical Intensive Care Unit
Veterans Affairs Hospital, Little Rock, AR
1996-97 Student Nurse Technician, Surgical Intensive Care Unit
Veterans Affairs Hospital, Little Rock, AR
Certifications/Registrations
Nursing Liscense: Arkansas, 2000
Minnesota, 2001
Wisconsin, 2001
BLS, 1995 to current
ACLS, 1997 to current
Critical Care, 1997
ECG, 1997
Professional Memberships
Sigma Theta Tau, Nursing Honor Society, 1997
Supply Budget
Supplies:
- copying costs, free to student at VA Hospital clinical site
- paper, free to student at Va Hospital clinical site
- transportation costs, incurred by student
- drug cost, supplied by clinical site anesthesia dept.
Time Line
4/2000 – Proposal complete
6/2000 – Submit proposal packet to University of Minnesota advisor and VA hospital IRB
8/2000 – Conduct research
9/2000 – Compile data, analyze findings
10/2000 – Complete plan B