Dataset Information

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: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.

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.

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