None listed
Conditions
Brief summary
Rocuronium is a commonly used steroidal non-depolarizing neuromuscular blocking agent with a rapid onset of action and an intermediate duration. However, even in unconscious patients during anesthetic induction, rocuronium causes withdrawal movement of the injected hand or arm, or generalized movements of the body after intravenous injection even leading to reflux of gastric contents and pulmonary aspiration. Pain from the injection of rocuronium is experienced by 75-100% of patients and 84% during induction of anesthesia after loss of consciousness. Although no patient complained of pain or recall after recovery, this withdrawal movement was most likely due to pain at the site of injection. Dexketoprofen is the S(+) enantiomer of ketoprofen, which is a COX-1 and COX-2 inhibitor arylpropyonic acid. It is a newly developed, centrally acting NSAID with potency similar to that of mu-opioid agonists. In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability profile after oral administration. Therefore arvelles might be suitable for preventing this distressing side-effect. However, no report has examined as to whether arvelles pretreatment reduces the withdrawal movement caused by rocuronium injection. The aim of this study was to compare the efficacy of pretreatment with oral arvelles with plasebo tablets, without tourniquet, for the prevention of withdrawal response from rocuronium injection. After Institutional Ethic Comitee approval and written, informed consent, will enroll 150 patients into the study, aged 18 to 75 years, belonging to American Society of Anesthesiologists physical status classification I and III patients will be scheculed for elective surgery with general anesthesia. Patients with difficult venous access on the dorsum of the hand, NSAID allergy, existence of serious hepatic, renal and gastric disease, history of peptic ulcer disease and coagulopathy, use of corticosteroids within the last 7 days; and use of anticoagulants within the last month, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, will be excluded from the study. Using a computer-generated randomized table in a sealed envelope, patients will randomly assigned to recieve either placebo tablets or arvelles 25 mg 30 minutes before induction. After 3 min of preoxygenation, 2.5% thiopental sodium 5 mg/kg will be injected. When the verbal response and the eyelash reflex were abolished, an intubating dose of rocuronium 0.6 mg/kg is injected over 5 seconds and intravenous fluid is continously be administer for 10 seconds. While rocuronium is being injected, withdrawal movement will be graded by an investigator, who is blinded to patient group assigned as follows: grade 0 = no response, grade 1 = movement/withdrawal at the wrist only, grade 2 = movement/withdrawal involving the arm only (elbow/shoulder), and grade 3 =generalized response with movement/withdrawal in more than one extremity, cough, or breath-holding .
Interventions
Dexketoprofen Trometamol (arvelles as the commercial name)is the S(+) enantiomer of ketoprofen, which is a COX-1 and COX-2 inhibitor arylpropyonic acid. It is a newly developed, centrally acting NSAID with potency similar to that of mu-opioid agonists. In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability profile after oral administration. Therefore arvelles might be suitable for preventing this distressing side-effect. However, no report has examined as to whether arvelles pretreatment reduces the withdrawal movement caused by rocuronium injection. The aim of this study was to compare the efficacy of pretreatment with oral arvelles with plasebo tablets, without tourniquet, for the prevention of withdrawal response from rocuronium injection. We will administer an oral capsule of 25 mg single dose 30 minutes before induction
Sponsors
Study design
Eligibility
Inclusion criteria
After Institutional Ethic Comitee approval and written, informed consent, will enroll 150 patients into the study, aged 18 to 75 years, belonging to American Society of Anesthesiologists physical status classification I and III patients will be scheculed for elective surgery with general anesthesia.
Exclusion criteria
Patients with difficult venous access on the dorsum of the hand, NSAID allergy, existence of serious hepatic, renal and gastric disease, history of peptic ulcer disease and coagulopathy, use of corticosteroids within the last 7 days; and use of anticoagulants within the last month, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, will be excluded from the study.