| Aims: 1.To investigate the effects of different doses of oxycodone hydrochloride on rocuronium injection pain.2.To investigate oxycodone hydrochloride inhibited the half effective dose(ED50),95% effective dose(ED95)and their 95% confidence interval(CI)of rocuronium injection pain by Dixon sequential method.Methodology:Part Ⅰ: The effects of different doses of oxycodone hydrochloride on rocuronium injection pain1.We select 150 patients undergoing endotracheal intubation for general anesthesia,ranging from 18 to 65 years in age,ASA grade I or II,45 to 75 kg in weight,BMI 18 to 30 kg/m2.2.Patients were fasted for 8 hours before surgery and banned for 2 hours.Routine monitoring ECG,non-invasive blood pressure,pulse oximetry,puncturing the right forearm thick venous,and continuously infusing compound sodium chloride injection by 10ml/kg×h.3.With computer generated random numbers,150 patients were randomly divided into five groups with 30 in each group.Group N: normal saline(10ml);group Q1: oxycodone hydrochloride 0.06mg/kg(10ml);group Q2: oxycodone hydrochloride 0.09mg/kg(10ml);group Q3: oxycodone hydrochloride 0.12mg/kg(10ml);group Q4: oxycodone hydrochloride 0.15 mg/kg(10 ml).4.Induction of anesthesia: First,each group was pretreated with the following scheme: normal saline or oxycodone hydrochloride.Three minutes after the pretreatment,injecting midazolam 0.05mg/kg.And five minutes later,injecting 1% rocuronium 0.6mg/kg within 10 s.Then we evaluate the pain scores and withdrawal scores after injection of rocuronium.After the evaluation,etomidate 0.3mg/kg and sufentanil 0.3 to 0.5ug/kg were used for intubation,immediately.5.Recorded data: We recored the systolic blood pressure(SBP),diastolic blood pressure(DBP),heart rate(HR),Pulse oximetry(Sp O2)at the following time: 1)5 minutes after entering the room(T0);2)before the injection of rocuronium(T1);3)after the injection of rocuronium(T2).At the same time,we recored the pain scores and withdrawal scores after injection of rocuronium.Also,we record the number of adverse reactions during induction period.During 24 hours after operation,patients were followed up for signs of pain,blisters,swelling,plaques,allergies,and other adverse reactions.The patients were asked whether there was any special discomfort during the Induction period and whether there was any postoperative respiratory depression.Part Ⅱ: ED50,ED95 and corresponding 95% CI of oxycodone hydrochloride for preventing rocuronium injection painThe study case selection and preoperative preparation are the same as the first part.Induction method is considered as the following.Each patient is pretreated with oxycodone hydrochloride.According to Dixon’s modified sequential method,the dose of oxycodone hydrochloride start from 0.12 mg/kg,and the pre-dose of the next patient is determined based on the reflection of the previous one: If the patient develops pain,the next dose of oxycodone hydrochloride rises by one level;if no pain appearerd,the next pre-dose decreases by one level.The increment of oxycodone hydrochloride doses is 0.02mg/kg.Rocuronium(1%,0.6mg/kg)was injected 5 minutes after oxycodone hydrochloride pretreatment,push for 10 s.After injecting the drug,the patient was asked whether pain appears.After the evaluation,midazolam 0.05mg/kg,etomidate 0.3mg/kg,sufentanil 0.3 ~ 0.5ug/kg were intubated immediately.The patient before the first positive pain reaction is considered as the beginning of this trial study.The study was terminated when seven consecutive positive or negative knee points of pain reaction occurred.Results:Part Ⅰ:1.Vital Signs: Comparing the SBP,DBP,HR T1 in group N,group Q1,group Q2 with those in T0,the difference was not statistically significant(P>0.05).The SBP,DBP,HR T1 in group Q3 and group Q4 were lower than those in T0,and the difference was statistically significant(P<0.05).The SBP,DBP,HR T2 of group N were significantly higher than that of T1,the difference was statistically significant(P<0.05).Comparing the SBP,DBP,HR T2 in group Q1,group Q2,group Q3 and group Q4 with those in T1,the difference was not statistically significant(P>0.05).There was no significant difference between the time of Sp O2 T1 and T0 and the time of T2 and T1 in the five groups(P>0.05).2.Adverse reactions: The incidence of adverse reactions in group Q3 and Q4 group was higher than that in group N,group Q1,group Q2(P < 0.05).The incidence of adverse reactions in group Q4 was higher than that in the group Q3,the difference was statistically significant(P < 0.05).3.Pain response: The incidence of pain in the group Q1,group Q2,group Q3,group Q4 were lower than in the group N(P<0.05);the incidence of pain in the group Q3 and group Q4 were lower than in the group Q1,group Q2,the difference was statistically significant(P<0.05).4.Limb extremity: group Q1,group Q2,group Q3,group Q4 had a significantly lower incidence of limb amputation than group N(P<0.05);group Q4 had a lower incidence of limb amputation than group Q2.The difference was statistically significant(P<0.05).5.Postoperative follow-up: No adverse reactions such as pain,swelling,blisters,plaque,and allergic reactions were observed in the injection site within 24 hours after the operation.The patient experienced no special discomfort during the induction period and no postoperative respiratory depression.Part Ⅱ: The ED50 of oxycodone hydrochloride injection inhibited the rocuronium injection pain was 0.120 mg/kg,95% CI [0.013-1.018 mg/kg],ED95 was 0.195 mg/kg,95% CI [0.052-1.340 mg/kg].Conclusions:1.Injecting oxycodone hydrochloride before induction of anesthesia can significantly reduce the incidence and severity of rocuronium injection pain;oxycodone hydrochloride dose of 0.12mg/kg is better,for the incidence of adverse reactions can be lower,with higher feasibility and safety.2.The ED50 of oxycodone hydrochloride injection inhibited the rocuronium injection pain was 0.120 mg/kg,95% CI [0.013-1.018mg/kg],ED95 was 0.195 mg/kg,95% CI [0.052-1.340 mg/kg]. |
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