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Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study.

ABSTRACT: BACKGROUND:Intranasal dexmedetomidine, a well-tolerated and convenient treatment option, has been shown to induce a favorable perioperative anxiolysis in children. We investigate intranasal dexmedetomidine as a sedative premedication for anesthesia recovery in an adult population. METHODS:A prospective randomized controlled trial; 81 adult patients scheduled for elective suspension laryngoscopy received intranasal dexmedetomidine (1 ?g?kg-1) or a placebo 45-60 min before anesthetic induction. Extubation time was used as the primary outcome measure. Secondary variables included the levels of sedation (Observer's Assessment of Alertness/Sedation scale, OAA/S) and anxiety (4-point anxiety score), anesthetic and analgesic requirements, hemodynamic fluctuations, and anesthesia recovery as well as side effects. RESULTS:The levels of sedation and anxiety differed significantly between the two groups at anesthesia pre-induction (p < 0.001 and = 0.001, respectively). Repeated-measure general linear model determined no significant interaction effect between group and time on the targeted concentration of propofol (F = 1.635, p = 0.200), but a significant main effect of group existed (F = 6.880, p = 0.010). A moderate but significant decrease in the heart rate was recorded in the dexmedetomidine group at pre-induction. Episodes of tachycardia and hypertension after tracheal intubation and extubation were more frequent in the placebo group. CONCLUSIONS:Intranasal dexmedetomidine as a sedative premedication induced a favorable perioperative anxiolysis without prolongation in anesthesia recovery; the hemodynamic effect was modest. TRIAL REGISTRATION:ClinicalTrials.gov NCT 02108171.

SUBMITTER: Lu C

PROVIDER: S-EPMC4873234 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study.

Lu Chengxiang C Zhang Li-Ming LM Zhang Yuehong Y Ying Yanlu Y Li Ling L Xu Lixin L Ruan Xiangcai X

PloS one 20160519 5

<h4>Background</h4>Intranasal dexmedetomidine, a well-tolerated and convenient treatment option, has been shown to induce a favorable perioperative anxiolysis in children. We investigate intranasal dexmedetomidine as a sedative premedication for anesthesia recovery in an adult population.<h4>Methods</h4>A prospective randomized controlled trial; 81 adult patients scheduled for elective suspension laryngoscopy received intranasal dexmedetomidine (1 μg∙kg-1) or a placebo 45-60 min before anestheti ...[more]

PMID: 27196121

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Project description:Functional Endoscopic Sinus Surgery (FESS) has been performed under controlled hypotension to increase operating field visibility. Intranasal (IN) dexmedetomidine is easy, noninvasive, and possesses lower C max, accompanied by lower pharmacodynamic action, including hypotension, bradycardia, and sedation. This trial aimed to compare IN and intravenous (IV) dexmedetomidine for hypotensive anesthesia during FESS. This randomized, controlled, triple-blinded clinical trial involved sixty cases scheduled for FESS. Patients were divided into two equal groups by random manner. 45-60 min before anesthesia induction, group IN: received 1 μg/kg IN dexmedetomidine diluted in 10 ml of saline 0.9 % intranasally preoperative. Group IV: received 1 μg/kg dexmedetomidine diluted in 10 ml of saline 0.9 % infused over 10 min. The primary outcome was the total amount of administered atropine. The secondary outcomes included hemodynamic, through 1 h before surgery, intraoperatively and postoperatively at different time intervals. The quality of the operative field, sedation, adverse reactions and hemostatic stuffing after FESS were also assessed. The total amount of consumed atropine decreased significantly in group IN compared to group IV. Preoperative Ramsay Sedation scores at T0, T5, T50 and T60 were comparable between the two groups, while at T10, T15, T20, T30, and T40 were lower significantly in the IN group compared with the IV group. Preoperative mean arterial blood pressure at T0, T5 and T60 had comparable differences across both groups while reduced at T10 to T 45 significantly in the IV group than IN group. Both groups had comparable satisfaction, postoperative Ramsey sedation, hemostatic suffering, quality of operative field and complications. In conclusion, IN dexmedetomidine administration is relatively simple and appropriate; moreover, it decreases first-pass metabolism. Onset is prolonged relative to IV dosing; thus, it should be administered nearly 1 h before surgery and recommended in adult patients as they require minor sedation preoperatively.

Project description:BackgroundChildren under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients' compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation.MethodsIn this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov-Smirnov Z, chi-square, Wilcoxon, and Mann-Whitney U tests. A P-value < 0.05 will be considered statistically significant.DiscussionThe MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period.Trial registrationClinicalTrial.gov NCT05192629 . Registered on 14 January 2022. Protocol version 2.1.

Project description:ImportancePerioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia, and they may be affected by the administration of preoperative sedatives.ObjectiveTo investigate the effect of intranasal dexmedetomidine or midazolam used for premedication on the occurrence of PRAEs.Design, setting, and participantsThis single-center, double-blind, randomized clinical trial was conducted among children aged 0 to 12 years undergoing elective tonsillectomy and adenoidectomy from October 2020 to June 2021 at Children's Hospital of Xuzhou Medical University, Xuzhou, China. Data analysis was performed from June to October 2021.InterventionsChildren were randomly assigned to 3 groups: the midazolam group received intranasal midazolam (0.1 mg/kg), and the dexmedetomidine group received intranasal dexmedetomidine (2.0 μg/kg) for premedication. The normal saline group received intranasal 0.9% saline for control.Main outcomes and measuresThe primary outcome was the difference in the incidence of PRAEs among the 3 groups. The secondary outcomes were the frequency of the individual PRAEs, including the incidence of such events during the induction and recovery periods, postoperative emergence delirium, postoperative pain score, sedation success rate, and heart rate values.ResultsA total of 384 children (median [IQR] age, 7 [5-10] years; 227 boys [59.1%]) were enrolled and randomized; 373 data sets were available for intention-to-treat analysis (124 children in the midazolam group, 124 children in the dexmedetomidine group, and 125 children in the normal saline group). After the data were adjusted for age, sex, American Society of Anesthesiologists physical status, body mass index, obstructive sleep apnea, upper respiratory tract infection, and passive smoking, children in the midazolam group were more likely to experience PRAEs than those in the normal saline group (70 of 124 children [56.5%] vs 51 of 125 children [40.8%]; adjusted odds ratio [aOR], 1.99; 95% CI, 1.18-3.35), whereas the dexmedetomidine group had a significantly lower PRAEs incidence than the normal saline group (30 of 124 children [24.2%] vs 51 of 125 children [40.8%]; aOR, 0.45; 95% CI, 0.26-0.78). Compared with the dexmedetomidine group, the midazolam group had a higher risk of PRAEs (aOR, 4.44; 95% CI, 2.54-7.76), but no other serious clinical adverse events were observed.Conclusions and relevanceIn this randomized clinical trial, intranasal midazolam used for premedication was associated with increased incidence of PRAEs, whereas premedication with intranasal dexmedetomidine was associated with reduced incidence of PRAEs. Where clinically appropriate, anesthesiologists should consider using intranasal dexmedetomidine for sedation in children undergoing tonsillectomy and adenoidectomy.Trial registrationChinese Clinical Trial Register Identifier: ChiCTR2000038359.

Project description:Objective: This study was determined to investigate the impact of intranasal dexmedetomidine (DEX) on postoperative sleep quality in older patients (age over 65) with chronic insomnia during their hospitalization after surgery. Design: A randomized double-blind controlled trial was conducted to compare the effects of intranasal dexmedetomidine spray with a placebo group. Setting and Participants: The study was carried out at Xiangya Hospital, Central South University. 110 participants with chronic insomnia were analyzed. Methods: This trial enrolled older patients who underwent total hip/knee arthroplasty and randomized them to receive intranasal dexmedetomidine (2.0 μg/kg) or saline daily at around 9 p.m. after surgery until discharge. The primary outcomes were subjective sleep quality assessed with the Leeds Sleep Evaluation Questionnaire (LSEQ). The secondary outcomes included the objective sleep quality measured with the Acti-graph, the Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI). The other outcomes included the incidence of delirium, levels of inflammatory factors, visual analog scale (VAS) pain scores, postoperative opioid consumption, and treatment-related adverse events. Results: 174 patients were screened for eligibility, and 110 were recruited and analyzed. The DEX group had significantly higher scores on both the LSEQ-Getting to sleep and LSEQ-Quality of Sleep at each time point compared to the placebo (p < 0.0001), The least squares (LS) mean difference in LSEQ-GTS score at T0 between placebo group and DEX group was 2 (95% CI, -1-6), p = 0.4071 and at T5 was -14 (95% CI, -17 to -10), p < 0.0001; The LS mean difference in the LSEQ-QOS score at T0 was -1 (95% CI, -4 to 1), p = 0.4821 and at T5 was -16 (95% CI, -21 to -10), p < 0.0001. The DEX group exhibited significant improvement in Total Sleep Time (TST), Sleep Onset Latency (SOL), and Sleep Efficiency (SE), at each time point after treatment compared to the placebo group (p < 0.0001). The PSQI and ISI scores in the DEX group were reduced after treatment (p < 0.001). No significant adverse events were reported with the use of dexmedetomidine. Conclusion and Implications: This study demonstrates that intranasal administration of dexmedetomidine improves postoperative sleep quality in older patients with chronic insomnia who undergo surgery, without increasing the incidence of adverse effects. Clinical Trial Registration: http://www.chictr.org.cn/, identifier ChiCTR2200057133.

Project description:BackgroundThe efficacy and safety of spinal anesthesia by intrathecal dexmedetomidine (DEX) for parturients undergoing cesarean section are still lack of evidence. This aim of our study was to evaluate the efficacy and safety of intrathecal DEX for parturients undergoing cesarean section to provide more data evidence for intrathecal applications.MethodsThree hundred parturients undergoing cesarean section under spinal anesthesia were randomly assigned into three groups: group B: 9.0 mg (1.2 ml) of 0.75% bupivacaine with saline (1 ml); group FB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 20 μg of fentanyl (1 ml); group DB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 5 μg of DEX (1 ml). Intraoperative block characteristics, parturients' postoperative quality of recovery, maternal and neonatal outcomes and the plasma concentration of DEX were measured. All parturients were followed up for 30 days to determine whether nerve injury occurred.ResultsCompared with group B, the duration of sensory block in group FB and group DB were significantly prolonged (108.4 min [95% Confidence Interval (CI) = 104.6-112.3] in group B, and 122.0 min [95% CI = 116.8-127.3] in group FB, 148.2 min [95% CI = 145.3-151.1] in group DB). The overall score of quality recovery in group DB (71.6 [95% CI = 71.0-72.2]) was significantly higher than that in group FB (61.5 [95% CI = 60.8-62.2]) and group B (61.7 [95% CI = 61.0-62.4]). There was no statistically significant difference among the three groups for PH, PaO2, and PaCO2 of newborn. The plasma concentration of DEX in umbilical artery and umbilical vein was low and cannot be detected. The 30-days follow-up of parturients did not show any new onset of back, buttock or leg pain or paresthesia.ConclusionsDEX is a potential local anesthetic adjuvant that the intrathecal combination of 5 μg DEX can safely exhibit a facilitatory block effect and improve parturients' recovery quality.Trial registrationChinese Clinical Trial Registry (Registration number # ChiCTR1900022019 ; Date of Registration on March 20th, 2019).

Dataset Information

Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study.

Publications

Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study.

Similar Datasets

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