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Analgesia, Sufentanil, Dexmedetomidine, Pain, Postoperative, What&,rsquo s Known Intrathecal additive drugs have emerged as favorites in spinal anesthesia. Dexmedetomidine has shown promise in previous reports as an additive agent in combination with different anesthetics in spinal anesthesia. What&,rsquo s New The combination of sufentanil and dexmedetomidine for spinal anesthesia yielded favorable results. The combined effects of sufentanil and dexmedetomidine can cause the earlier onset and later regression of sensory and motor blocks, longer postoperative analgesia, and lower analgesic use without significant side effects or hemodynamic changes. IntroductionSpinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs owing to its quick effect and cost-effectiveness. 1, - 4, In recent years, intrathecal additive drugs have been used more often on the strength of their positive effects on the duration of blocks, the success rate, the patient&,rsquo s satisfaction, the use of anesthetics, the need for general anesthesia, and the recovery time. They have been reportedly effective in the prolongation of intraoperative and postoperative analgesia. 5, Several drugs such as fentanyl, sufentanil, ketamine, tramadol, neostigmine, and magnesium sulfate are used as additives. 6, Since dexmedetomidine was proposed as a short-acting and fast-acting alpha-2 agonist, it has been used as an intravenous sedative in patients admitted to intensive care units. The consumption of alpha-2 agonists reduces the need for anesthetics and causes hemodynamic stability in patients as these drugs have sympatholytic effects. Alpha-2 agonists are also effective in reducing postoperative pains and shivering. In addition, the use of alpha-2 adrenergic agonist drugs as prodrugs not only causes somnolence and relieves anxiety in patients but also decreases their heartbeat and blood pressure during anesthesia. 5, , 7, Most clinical studies on intrathecal alpha-2 adrenergic drugs have been conducted using clonidine. 8, - 10, Dexmedetomidine is approximately 10 times more alpha-2&,ndash selective than clonidine. 11, , 12, As little as 3 &,mu g of dexmedetomidine can prolong motor and sensory blocks without hemodynamic compromises. 7, , 13, Moreover, dexmedetomidine, similar to opioids and midazolam, has been used to relieve intra-articular pains. 14, , 15, It has also been proposed that intrathecal dexmedetomidine can induce better postoperative analgesia with trivial side effects, when used along with bupivacaine for spinal anesthesia. 13, , 16, However, few studies have investigated the efficacy and safety of this new alpha-2 adrenergic agonist as an adjunct drug in spinal anesthesia. 5, , 6, , 17, Therefore, we aimed to evaluate the effects of dexmedetomidine on the quality and duration of spinal anesthesia with sufentanil in patients undergoing lower abdominal or lower extremity surgery.Patients and MethodsEthical Considerations and Study SettingsThis double-blind randomized controlled trial was carried out in the general surgery and orthopedics departments of Ghaem Hospital and Imam Reza Hospital, affiliated with Mashhad University of Medical Sciences, Mashhad, Iran, between 2017 and 2018.Written informed consent was obtained from all the patients. The study was approved by the Ethics Committee of the Medical School of Mashhad University of Medical Sciences (approval code, IR.MUMS.fm.REC.1394.547). The study has been registered with the Iranian Registry of Clinical Trials (IRCT) at http,//irct.ir (registered number, IRCT2017082833680N3).Study PopulationKeeping an alpha error of 0.05 and a beta error of 0.2 with an 80% study power, according to the study by Yekta&,#351 and others, we calculated the sample size to be a minimum of 42 (21 patients in each group).18 We used the following formula, considering the mean&,plusmn SD of group 1 and group 2 to be 220.75&,plusmn 112.7 and 371.5&,plusmn 223.5, respectively. 19, n = ( Z 1 - &,alpha 2 + Z 1- &,beta ) 2 ( S 1 2 + S 2 2 ) ( X - 1 - X - 2 ) 2 Nonetheless, we extended the sample size to 60 (30 patients in each group), assuming a possible 30% dropout rate in this population. Finally, 60 patients undergoing surgery on the lower abdomen or the lower extremities in our center were recruited via simple random sampling method.The study was performed on 60 patients undergoing surgery on the lower abdomen or the lower extremities in the general surgery and orthopedics wards of Ghaem Hospital and Imam Reza Hospital. The inclusion criteria were comprised of being between 18 and 60 years old, being classified as Class I or II of the American Society of Anesthesiologists (ASA) classification, and having the indications of spinal anesthesia for the upcoming lower abdomen or lower extremity surgery.Patients with drug addiction, diabetes mellitus, neuropathy, neuromuscular diseases, known allergies to the study drugs, or any contraindications of spinal anesthesia (e.g., raised intracranial pressure, localized sepsis, non-immobilization during puncture, or septic shock) were excluded from the study.InterventionThe patients were randomly assigned to two groups of intervention (n=30) and control (n=30), after they provided written informed consent. Random allocation was done using a simple randomization technique and a table of computer-generated random numbers. Assignment concealment was done using sealed opaque envelopes. The investigators involved in data collection and analysis were blinded.A fellow researcher, who was not involved in data collection and analysis, prepared the drugs according to the study protocol in concealed syringes, and then delivered them for injection to an anesthesiologist in the research team, who was blinded to the assignment of the patients. Spinal anesthesia was performed by the blinded anesthesiologist for all the participants in the sitting position with a 25-gauge Quincke spinal needle (Dr. Japan co. Ltd., China) through L3&,ndash L4 or L4&,ndash L5 spaces under standard sterile conditions.The control group patients were injected intrathecally with 15 mg of bupivacaine (Marcaine&,reg , AstraZeneca, Sweden) and 3 &,mu g of sufentanil (Sufiject&,reg , Aburaihan Iran). The intervention group received 15 mg of bupivacaine, 3 &,mu g of sufentanil, and 10 &,mu g of dexmedetomidine (Precedex&,reg , Hospira, US) injections. After injection, the patients were immediately placed in the supine position. The patients and the person collecting the information were blinded to the group labels and the type of medications received.Data GatheringBefore transferring the patients to the operating room, their baseline characteristics were documented. Demographic data, including age and gender, as well as clinical data, including past medical history and drug history (with an especial focus on hypertension), were recorded in a checklist.Following the standard conditions, the basic monitoring of vital signs, including systolic, diastolic, and mean arterial blood pressures, the heart rate, and O2 saturation, was applied in all the patients. Vital signs were recorded every five minutes during the first 30 minutes and then every 10 minutes until the end of the operation. Vital signs were also recorded in the recovery room every 15 minutes for 60 minutes.Any decline in the mean arterial pressure of more than 20% of the preoperative record was treated using a 6 mg intravenous ephedrine (STEROP, Belgium) injection. Reductions in the heart rate of below 50 beats per minute were also treated using 0.5 mg intravenous atropine injections.A blinded researcher evaluated the sensory dermatome level bilaterally by cold sensation along the midclavicular line using an alcohol swab. The preoperative assessment was done every one minute until the sensory block level reached the T10 dermatome, and remained constant for two consecutive evaluations. After surgery, the time needed for regression to the S1 dermatome was also recorded.The same investigator blindly assessed the motor dermatome level every one minute according to the modified Bromage scale, where zero means no block, one indicates an inability to move the hip, two denotes the inability to move the hip and the knee, and three shows the inability to move the hip, the knee, and the ankle. The times needed to reach Bromage three before surgery, and regress to Bromage zero after surgery were recorded.All the times were recorded with reference to the time of spinal injection as time zero. In cases whose sensory levels of anesthesia on both sides were not equal, the side with a higher level was recorded.The patients were instructed to use a 10-point visual analog scale (VAS) for the description of their pain severity, with zero indicating no pain at all and 10 denoting the most painful experience. The extent of analgesia was evaluated using VAS at 1, 3, 6, 12, and 24 hours after surgery. If the patients reported VAS scores of greater than four, they received a 0.5 mg intravenous injection of pethidine (Exir co., Iran).The amount of analgesic consumption during the first 24 hours after surgery, the time of becoming able to urinate for the first time following surgery, and the side effects of the drugs including nausea, vomiting, itching, shivering, and headache were recorded for all the patients.Statistical AnalysisAll the data were analyzed using the SPSS software, version 16 (IBM Statistics, Chicago, USA). The results were described using mean&,plusmn SD, and frequencies (percentages) or values. Data normality was assessed using the Kolmogorov&,ndash Smirnov test. The between-group comparison of the data was performed using the repeated measures ANOVA test, the independent samples t test, and the chi-square or Fisher exact test. A P value of less than 0.05 was considered statistically significant.ResultsOverall, 60 patients in two groups of intervention (n=30) and control (n=30) were studied (figure 1,). The study groups had no significant differences regarding gender (P=0.08) and age (P=0.42). Nevertheless, they showed no difference concerning the medical history of hypertension or the drugs related to it. Table 1, indicates the comparison of the baseline demographic and clinical characteristics of the patients between the intervention and control groups.VariableControl (Bupivacaine+Sufentanil) Group (n=30)Intervention (Bupivacaine+Sufentanil+Dexmedetomidine) Group (n=30)P valueAge 38.10&,plusmn 13.8440.76&,plusmn 11.990.420a,GenderMale25 (83.33%)19 (63.33%)0.080b,Female5 (16.67%)11 (36.67%)Hypertension drug history2 (6.7%)2 (6.67%)1.000b,Hypertension history2 (6.7%)2 (6.67%)1.000b, aIndependent samples t test was used bChi-square test or the Fisher exact test was used |